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Senior Regulatory Affairs Specialist

Company Name: Mainstay Medical Job Location: 2159 India Street Suite 200 San Diego, CA 92101 Position Title: Senior Regulatory Affairs Specialist Position Type: Full time General Job Description Mainstay Medical is seeking a driven and passionate Senior Regulatory Affairs Specialist to work on PMA Class III/active implantable devices. This individual will be managing the regulatory processes for both the U.S. FDA and International (CE mark, Australia, and others) markets at Mainstay Medical in San Diego, California. You will develop regulatory strategies, organizing regulatory information and execute regulatory submissions to both the U.S. FDA and international regions. You will also review and advise on labeling or advertising/promotional materials for compliance with the regulatory filings. We hope you will join us on this journey to ReActiv8 life. Responsibilities: Good understanding of medical device regulation (FDA, EU and international), quality systems requirements (FDA and ISO 13485) Ability to work independently and with all levels of managers, associates, and teams Plan, generate, and coordinate worldwide regulatory submissions for product approvals, and maintenance of existing regulatory approvals, including submitting PMA and IDE annual reports, CE mark, PMA supplements and PMA 30-day notices Review engineering change orders or project deliverables such as: design verification and design validation protocol and reports as well as process validation protocols and reports. Develop and maintain technical documentation files/design dossier in accordance with the EU regulations Review labeling and ad-promo materials to ensure compliance Support audits and continuous improvement activities, develop and update procedures Communicate with the regulatory bodies Complete all other related duties assigned. Qualifications: B.S. degree in engineering, medical, biological, or related fields 3+ years’ experience in medical device regulatory affairs submissions RAC certification Experience with AIMDD and US Class III devices regulatory submissions Excellent written and verbal communication skills Project management experience Excellent verbal communication and interpersonal skills. Demonstrated excellent organizational skills with attention to detail. Proficient in computer operations, including Microsoft Word, Outlook, Excel PowerPoint, and basic database management. Problem solver and capable to find solutions to challenges. Application Information & Contact (How to Apply) Forward your resume to: careers@mainstay-medical.com Learn more about the company here

Senior Design Quality/Design Assurance Engineer

Company Name: Mainstay Medical Job Location: 2159 India Street Suite 200 San Diego, CA 92101 Position Title: Senior Design Quality/Design Assurance Engineer Position Type: Full time General Job Description Mainstay Medical is seeking a driven and passionate Senior Design Quality/Design Assurance Engineer. This individual will actively participate in product development teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled. Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the lifetime of the device. We hope you will join us on this journey to ReActiv8 life. Responsibilities: Good understanding of medical device regulation (FDA, EU and international), quality systems requirements (FDA and ISO 13485) Familiarity with IS0 14971 and product stands such as IEC60601, 10993, and other medical device standards. Ability to work independently and with all levels of managers, associates, and teams Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the lifetime of the device. Generates and/or reviews related project deliverables such as: design verification and design validation protocol and reports as well as process validation protocols and reports. Coordinates with Production development in the review of technical documentation. Works with Product Development/Manufacturing in the development of test fixtures, develop production acceptance criteria and test methodology. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination. Provides support in conducting root cause analyses, preparation of CAPA and Product Risk Assessment. Draft and update SOPs as required. Support audits and continuous improvement activities Complete all other related duties assigned. Qualifications: B.S. degree in Engineering or related fields 3+ years’ experience in Design Assurance, including Quality systems, standards, metrics, and tools. Advanced degrees will substitute for 1 year of experience. Certified Quality Engineer (CQE) Excellent verbal communication and interpersonal skills. Demonstrated excellent organizational skills with attention to detail. Proficient in computer operations, including Microsoft Word, Outlook, Excel PowerPoint, and basic database management. Problem solver and capable to find solutions to challenges. Application Information & Contact (How to Apply) Forward your resume to: careers@mainstay-medical.com Learn more about the company here

Senior Quality Engineer

Company Name: Mainstay Medical Job Location: 2159 India Street Suite 200 San Diego, CA 92101 Position Title: Senior Quality Engineer Position Type: Full time General Job Description Mainstay Medical is seeking a driven and passionate Senior Design Quality/Design Assurance Engineer. This individual will actively participate in product development teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled. Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the lifetime of the device. We hope you will join us on this journey to ReActiv8 life. Responsibilities: Good understanding of medical device regulation (FDA, EU and international), quality systems requirements (FDA and ISO 13485) Familiarity with IS0 14971 and product stands such as IEC60601, 10993, and other medical device standards. Ability to work independently and with all levels of managers, associates, and teams Leads Risk Management (ISO 14971) activities. May lead cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the lifetime of the device. Generates and/or reviews related project deliverables such as: design verification and design validation protocol and reports as well as process validation protocols and reports. Coordinates with Production development in the review of technical documentation. Works with Product Development/Manufacturing in the development of test fixtures, develop production acceptance criteria and test methodology. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination. Provides support in conducting root cause analyses, preparation of CAPA and Product Risk Assessment. Draft and update SOPs as required. Support audits and continuous improvement activities Complete all other related duties assigned. Qualifications: B.S. degree in Engineering or related fields 3+ years’ experience in Design Assurance, including Quality systems, standards, metrics, and tools. Advanced degrees will substitute for 1 year of experience. Certified Quality Engineer (CQE) Excellent verbal communication and interpersonal skills. Demonstrated excellent organizational skills with attention to detail. Proficient in computer operations, including Microsoft Word, Outlook, Excel PowerPoint, and basic database management. Problem solver and capable to find solutions to challenges. Application Information & Contact (How to Apply) Forward your resume to: careers@mainstay-medical.com Learn more about the company here

MEMBER APPRECIATION EVENT

Register Here MEMBER APPRECIATION EVENT Please join us on Tuesday, 12 October 2021 Starting at 6:00pm for a very special online interactive Member Appreciation Event SUPERHERO ACADEMY FLYER Event Agenda: Date: Tuesday, 12 Oct 2021 Time: 6:00 – 7:30 PM Program Topic: Here we are again! For our second online member appreciation event, please join us on Tuesday, 12 October 2021 at 6:00pm for our virtual Superhero Academy team building experience! Let’s have as much fun as we did last year! For 1.5 hours, an expert Super-visor will guide you and your team through your Super-mission. You will have to solve puzzles, and combine each of your team’s Superhero strengths to overcome the Supervillains and win your mission! Get ready for some (virtual) action-packed physical challenges! We need your help to defeat Supervillains and save the world!! Plus, don’t miss the opportunity drawing with the chance to win free annual memberships and monthly programs! Please make your reservation early for this annual Members Only event! Location: Not applicable - This is an online event Online registration (ends 10Oct2021):

$10 SDRAN Member For Questions Email: membership@sdran.org

Unique Device Identification (UDI): Implementation and its real world use cases

Register Here SDRAN Monthly Program Unique Device Identification (UDI): Implementation and its real world use cases Program Speaker: Terrie Reed Director Partner Relationships, Symmetric Health Solutions FLYER Event Agenda: Date: Wednesday, 20 Oct 2021 Time: 6:00 – 6:05 PM Welcome and Announcements 6:05 – 7:05 PM Program Presentation 7:05 – 7:30 PM Q & A Program Topic: Unique Device Identification (UDI): Implementation and its real world use cases The UDI system was created by the International Medical Device Regulators Forum (IMDRF) providing guidelines to establish UDI as a standard for device identification that manufacturers would be required to apply to a device label and submit information about the model/version of the device to a publicly available database in each participating jurisdiction. While participation in the UDI System is voluntary, the FDA, followed by Europe and many other jurisdictions have chosen to implement UDI. The goals in the US and Europe include using UDI to improve regulatory processes as well as have a positive impact on clinical care, patient safety and clinical evaluation of devices. This session will include a review of the history of the global UDI system, current state of UDI in the US and a personal view of the opportunities and challenges of implementing the US UDI System by panelists who are experts in US regulation, health IT software development, and hospital supply chain operations. Speaker Biography: Terrie Reed – Director Partner Relationships, Symmetric Health Solutions. Former Associate Director of Informatics at the Food and Drug Administration (FDA) Terrie has spent the past 15 years advocating for a safer, better functioning medical device ecosystem. As Associate Director of Informatics, she led the FDA’s development of the Global Unique Device Identification Database (GUDID), the foundation of recent efforts to introduce data standards and transparency to stakeholders ranging from health systems to manufacturers, distributors, researchers, and patients. In her role as Director, Partner Relationships at Symmetric Health Solution, Ms. Reed has seen first-hand the power of UDI to improve the efficiency of the healthcare supply chain and clinical data in hundreds of hospitals that are choosing to replace custom product identifiers with a scannable globally unique identifier tied to standard information stored in FDA’s AccessGUDID. As UDI adoption increases, further improvements in patient safety, post-market surveillance of medical devices, and device innovation are becoming possible, not only in the US but globally as the European Union, Korea, and other jurisdictions are creating their own UDI databases based upon internationally harmonized principles of a global UDI System. Ms. Reed continues to influence global efforts through consultancies with the WHO, participation in public private partnerships and cross-stakeholder communities where she contributes to efforts to document and share best practices on the use of UDI to promote interoperability in health IT standards. Location: Not applicable - This is an online event Online registration (ends 19Oct2021):

$10 SDRAN Member $15 Non-Member For Questions Email: programs.committee@sdran.org

Clinical Supply Chain Management: Dude, Where's My Patient Benefit?

Register Here SDRAN Monthly Program Clinical Supply Chain Management: Dude, Where's My Patient Benefit? Program Speaker: Dr. Lequina Myles, DRSc, MS, MBA, RAC, PMP, PMI-ACP Senior Director of Quality Assurance and Regulatory Affairs Phenomenex (a Danaher Company) FLYER Event Agenda: Date: Wednesday, 15 Sep 2021 Time: 6:00 – 6:05 PM Welcome and Announcements 6:05 – 7:05 PM Program Presentation 7:05 – 7:30 PM Q & A Program Topic: Clinical Supply Chain Management: Dude, Where's My Patient Benefit? The objectives of this discussion are to: General Overview of Clinical Supply Chain Management and how it fits into the Drug Development Cycle Understand Operational and Regulatory Landscape of Clinical Supply Chain Overview of Good Distribution Practices Challenges and Opportunities for Clinical Supply Chain (eg, temperature sensitive biopharmaceuticals, cell therapies, gene therapies, alternative distribution models: Direct to Patient) Supply Chain Management during COVID-19 Speaker Biography: Dr. Lequina Myles, DRSc, MS, MBA, RAC, PMP, PMI-ACP has over ten years of experience within the pharmaceutical and biotechnology industries. Lequina currently works as a Director of Quality Assurance and Regulatory Affairs. Her previous role was Regional Quality Director providing quality oversight for international and domestic life science, medical product, and clinical trial supply chain management and distribution. Lequina started her career in the Quality Control Biochemistry Laboratories and moved up through the ranks managing and supporting global projects, which increased organizational efficiency, productivity, and improved client retention and strategic partnerships. Also, Lequina has provided expertise in project management, continuous improvement, and training and development to various organizations. Lequina holds a B.S. in Biochemistry from the University of California, Los Angeles (UCLA) and a Master of Business Administration (MBA) with an emphasis in Project Management from Mount Saint Mary's University. Lequina also obtained a Master of Regulatory Science and Doctor of Regulatory Science (DRSc) from the University of Southern California. Lequina is a certified Project Management Professional (PMP) and holds a Regulatory Affairs Certification (RAC) in both drugs and devices. In addition to industry experience, Lequina is an Adjunct Faculty in the MBA Program at Mount Saint Mary's University teaching project management and serves as a Guest Lecturer at the University of Southern California at the School of Pharmacy. Lequina is passionate about learning and solving innovative and complex problems. Lequina’s research interests are innovative therapies such as cell and gene therapies and developing clinical and commercial strategies to improve patient access and address unmet medical needs. She also enjoys traveling, mentoring others, and teaching. Location: Not applicable - This is an online event Online registration (ends 14Sep2021):

$10 SDRAN Member $15 Non-Member For Questions Email: programs.committee@sdran.org

VIRTUAL NETWORKING EVENT

Register Here Join us for an hour of networking and fun on Zoom breakout rooms! Our first special networking event this year! Perfect opportunity if you are looking to transition or just started in regulatory affairs Network with other SDRAN members and regulatory affairs professionals Hop onto different “Drugs” or “Devices” breakout rooms Come prepared with a 2-minute elevator speech…and one peculiar fact about you! FLYER Date: Wednesday, August 25, 2021 Time: 6:00 pm – 7:00 pm PST 25 attendees minimum!! Registration is Free! Registration ends Sunday August 22, 2021 You will receive the Zoom meeting link before the event. Questions? Email: Membership@sdran.org Location: Not applicable - This is an online event

Associate Director/Director, Regulatory Affairs

Company Name: Longboard Pharmaceuticals Job Location: United States/Remote Position Title: Associate Director/Director, Regulatory Affairs Position Type: Full time General Job Description Working in a team environment, the Associate Director/Director, Regulatory Affairs will be responsible for development of regulatory strategy as well as hands-on management of all technical and operational aspects related to the regulatory lifecycle (e.g., from preclinical candidate designation through registration) of assigned Longboard Pharmaceutical products. Responsibilities: Strategic Planning: Represent the Regulatory Affairs department on multidisciplinary product development teams, develop and implement regulatory strategy for one or more programs, research regulatory precedent related to product class and therapeutic area(s) and assess implications for LP product development/registration, contribute to global product development plans and target product profiles, lead preparation of pediatric investigation plans and rare disease designation applications Operations: Manage all operational aspects of regulatory submissions, including maintaining timelines; organizing submission content; and coordinating the internal/external authoring and review of components of original investigational drug applications, amendments, safety and annual reports, interface with external Regulatory Operations group in the compilation of regulatory submissions in electronic common technical document format, serve as primary liaison for communication with regulatory health authority on assigned programs, prepare team for and lead the conduct of milestone development meetings with regulatory health authority Compliance: Review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure compliance of all development activities with applicable US and international regulations and guidelines, participate in the development and review of standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements, monitor company progress toward fulfillment of regulatory commitments Qualifications: Bachelor’s degree in life sciences required; advanced degree preferred Regulatory Affairs Certification (RAC) a plus Minimum 7 years pharmaceutical Regulatory Affairs experience with focus in development of drugs/biologics Direct experience in preparation, submission and lifecycle management of investigational/marketing applications, including as primary regulatory author Experience negotiating and directly interfacing with US and international regulatory authorities In depth knowledge of GxP/ICH guidelines and regulations Experience in CNS-related therapeutic area and rare disease development a plus Strong written and verbal communication, and ability to communicate regulatory strategy to key stakeholders at all levels of the organization High level of analytical, organizational, and interpersonal skills Ability to work in a dynamic environment with a high degree of flexibility Proven ability to interact effectively across multiple functional groups and projects Ability to travel up to 20% (US and International) Application Information & Contact (How to Apply) Please email your resume to careers@longboardpharma.com Learn more about the company here

IVDR Implementation: Key Considerations Amidst the Looming Deadline

Register Here Monthly Program event 'co-organized' by SDRAN and OCRA IVDR Implementation: Key Considerations Amidst the Looming Deadline Program Speaker: Gail Gasior, CCRA, RAC, RQAP-GCP Director, Clinical Compliance, Diagnostic Solutions Division Hologic, Inc. & Terrance (TJ) Thiel, RAC Director and Principal Consultant / Consulting Operations Brandwood CKC FLYER Event Agenda: Date: Wednesday, 18 Aug 2021 Time*: 5:30 - 5:40 PM Introductions SDRAN- Sasi Mudumba OCRA-Tommi Papson 5:40 – 6:25 PM TJ Presentation: MDR/IVDR comparison, PERs, and post marketsurveillance 6:25 – 7:10 PM Count-down to implementation, pitfalls and best practices 7:05 – 7:30 PM Q&A, hot topics panel Program Topic: As the IVDR implementation looms closer this program will provide valuable feedback and lessons learned from two thought leaders that are working closing for IVDR certifications. The program will address most recent developments of IVDR, including a status update about notified bodies and implementation deadlines. We will address possible points of confusion between MDR and IVDR as well as share best practices and pitfalls to avoid. Topics will include: Count-down to implementation Guidance and Feedback for Notified Bodies Pitfalls and best practices IVDR to MDR Comparison Performance Evaluation Reports High-Risk Product and Product Batch Release requirements Hot Topics Panel & Q&A at the End Speaker Biography: Gail Gasior, CCRA, RAC, RQAP-GCP Director, Clinical Compliance, Diagnostic Solutions Division, Hologic, Inc. I have 25 years of experience in in-vitro diagnostics clinical trial conduct, design and oversight. The last eleven years I have led the Clinical Compliance function at Hologic (formerly Gen-Probe). I lead the ongoing development and oversight of a robust Clinical Quality Management System to ensure that Clinical Affairs activities are in accordance with company policies and procedures, applicable current laws, regulations and guidelines. I collect and disseminate clinical regulatory intelligence by participating in industry and regulatory working groups and by working with divisional and corporate policy committees. I participate on the AdvaMed Clinical Trial Working Group on topics relevant to IVDs, and the MedTech Europe Clinical Evaluation Working Group. I sat on the ISO Working Group that developed and recently published the new standard ISO 20916, In vitro diagnostic medical devices – Clinical Performance Studies using specimens from human subjects – Good study practice. Terrance (TJ) Thiel, RAC, Director and Principal Consultant / Consulting Operations Brandwood CKC TJ Thiel has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches. TJ has prepared, submitted and achieved significant approvals for medical devices – including active implantables (AIMDs), implantables and Software as Medical Device (SaMD) – and in vitro diagnostics including point-of-care, self-testing and laboratory devices. TJ holds Regulatory Affairs Certification (RAC) and has delivered regulatory approvals including FDA 510(k), PMA and De Novo; CE-marking; Health Canada; TGA; PMDA and NMPA. Location: Not applicable - This is an online event Online registration (ends 17Aug2021):

$15 SDRAN Member $15 OCRA Member $20 Non-Member For Questions Email: programs.committee@sdran.org

Senior Regulatory Affairs Specialist

Company Name: Invivoscribe Job Location: San Diego, CA Position Title: Senior Regulatory Affairs Specialist Position Type: Full time General Job Description We are looking to add a Senior Regulatory Affairs Specialist will help develop the strategic direction and execute the tactical operational aspects of regulatory compliance and submissions for drug-device combination products. S/he will assure regulatory submission projects are completed on time and that related development files are maintained. Responsibilities: Responsible for generating submissions (Investigational Medicinal Product Dossier (IMPD), New Drug Application (NDA), Investigational New Drug (IND), etc.) to the FDA, NB and ROW agencies. Assess appropriateness of Design Control documents including discovery, CMC and clinical development. Supports IVD projects and submissions. Submits required clinical trial progress reports. Submits required adverse event reports. Submits required annual reports. Provides regulatory guidance to other departments. Qualifications: B.S. degree in Chemistry, Engineering, Biology, or scientifically related field with 5+ years’ experience in a Regulatory department (medical devices or pharmaceuticals.) and 3+ years’ experience with drugs, biologics, and/or combination products. Equivalent combination of education and experience will be considered. Demonstrated experience with all levels of regulatory submissions – IDE/IND, PMA, 510(k), NDA, etc. with knowledge of international regulatory processes preferred. Ability to inform and educate personnel on regulations and policies that impact company’s products and operations. Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint), and the ability to learn new software programs. Application Information & Contact (How to Apply) Apply here

Manager/Sr. Manager, Regulatory Affairs

Company Name: Gossamer Bio Job Location: San Diego, CA Position Title: Manager/Sr. Manager, Regulatory Affairs Position Type: Full time General Job Description The Manager/ Sr. Manager, Regulatory Affairs will manage, evaluate, and complete regulatory projects consistent with company goals. The Sr. Manager, Regulatory Affairs will be responsible for tracking regulatory commitments, deliverables and submission content in each region. Responsibilities will span all clinical trials from early stage through NDA/BLA. The Sr. Manager, Regulatory Affairs will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. Working closely with departmental leadership, the Sr. Manager, Regulatory Affairs will represent Regulatory Affairs on cross-functional project teams, will provide departmentally aligned input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive. Responsibilities: Assist in the development and implementation of a global regulatory strategy for assigned projects, along with Global Regulatory Lead(s) and Regulatory CMC. Collaborate with Regulatory Operations to compile and review regulatory submissions for completeness and quality. Ensure that submissions are in conformance with the latest industry and health authority submission standards Assist with logging, tracking and filing of correspondence and submissions to/from regulatory authorities and ensure that no commitment remains outstanding. Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs. Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances, and current industry practice. Qualifications: Manager Level requires Bachelor’s degree in scientific discipline with 7 years pharmaceutical industry experience, including 5+ years in Regulatory Affairs. Sr Manager level requires Bachelor’s degree in scientific discipline with 9 years pharmaceutical industry experience, including 7+ years in Regulatory Affairs. Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical). Experience with CTD/eCTD. Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Working knowledge of FDA and ICH regulatory guidance and regulations. Experience of Regulatory Intelligence Management (RIM) or Electronic Document Management System (EDMS) would be an advantage. Strong organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. Self-motivated, takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary. Knowledgeable in industry trends for regulatory affairs. Clinical Study support experience required. Domestic and occasional International travel may be necessary. Application Information & Contact (How to Apply) Apply here

University of Georgia-FDA Regulatory Conference and Workshop

8th Annual Medical Device Regulations Conference September 21-23, 2021 Register Here Medical Device manufacturers, Biodesign Innovators, Regulatory and QA Professionals, and Academics can register now for the 8th Annual UGA/FDA Medical Device Regulations Conference! This conference is co-sponsored by the US Food and Drug Administration and the University of Georgia’s International Biomedical Regulatory Sciences. It will provide educational and networking opportunities to help shape and advance the future of medical device regulatory sciences. Using a tutorial approach, experienced leaders from the FDA, Notified Bodies, the medical device industry, and consulting firms will present and engage the audience on issues related to medical device regulations. The 8th Annual UGA Medical Device Regulations Conference will be held virtually by the University of Georgia College of Pharmacy on September 21-23, 2021. The conference will be of special interest to quality assurance and regulatory affairs professionals working in the medical device industry in the US. The broad range of topics outlined under the Agenda will be presented by highly experienced professionals and technical experts from FDA and medical device industry. Hotel reservations are the responsibility of the individual conferees. Proposed Topics for the conference: FDA Updates: CDRH and ORA Notified Bodies Updates International Updates COVID-19 EUA Lessons Learned Remote Regulatory Assessment Tissue-based Devices Digital Devices