Astute Medical, Inc.
3550 General Atomics Ct, Building 2, San Diego, CA 92121
Sr. Regulatory Specialist
General Job Description:
This position will provide support to the Vice President, Clinical & Regulatory Strategy in the implementation of global regulatory strategies for marketed and development products. This individual will lead or support regulatory activities for internal and external programs and will work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings.
Support management with development and implementation of departmental strategies and policies.
Manage, coordinate and review regulatory submission/registration documentation for domestic and international product registrations, including the Independent determination of the necessary design documentation (including language/labeling requirements).
Interpret regulations and provide regulatory guidance and strategy to cross functions project teams.
Develop gap and impact assessments of changing global regulatory requirements (e.g., IVDR) and revise or drafts new documentation accordingly.
Compile and maintain regulatory database of regulatory information, labeling and change requirements for international registrations to support market expansion.
Regulatory lead on product/project teams, providing regulatory guidance with respect to product development and design control (changes and processes) and responsible for the preparation and review of associated deliverables.
Independently research, prepare, and present on global regulatory topics to internal and external stakeholders. Contribute to the development and implementation of regulatory strategy to mitigate risks.
Assure compliance with all applicable (domestic and international) regulations.
Monitor regulatory trends and be able to apply learnings and provide guidance or strategy related to such trends.
Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
Ensure compliance with Company’s Quality Management System and ensure that all individuals reporting to him/her comply with the Company’s Quality Management System.
May mentor or lead other department staff.
Other duties as assigned.
Degree in a relevant field (BS/MS in engineering or science ideal) with 4-6 years relevant MD/IVD regulatory affairs experience (or equivalent combination education and/or work experience in another function with demonstrated transferable skills set dependent on the level of qualifications achieve.
IVD, clinical diagnostic, CLIA or similar experience is preferred.
General working knowledge of current and evolving state, federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR, CMDR, and other worldwide regulatory regulations as appropriate and standards, e.g., ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of IVDs.
Prior direct interactions with Health Authorities is desirable.
Highly self-motivated; works on assignments of moderate scope where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
Exceptional writing skills and verbal interpersonal skills to influence many diverse internal/external customer groups.
High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently.
Ability to work cohesively with multi-disciplinary scientific working groups.
Good organization, interpersonal and judgment skills to influence many diverse internal/external customer groups.
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio.
Application Information & Contact (How to Apply)
Please apply through their career page here.
Learn more about Astute Medical here.