Manager, Regulatory Affairs and Quality Assurance (Medical Device Software)
12 Sigma Technologies
San Diego, CA
Manager, Regulatory Affairs and Quality Assurance (Medical Device Software)
Position Type:
Full Time
General Job Description:
The Regulatory Affairs (RA) and Quality Assurance (QA) manager will represent RA and QA on cross-functional project teams to provide support and guidance. The manager will implement overall regulatory strategy and quality management system (QMS) to ensure high quality submissions to FDA, in compliance with regulations and guidelines for medical devices, especially for software products.
Responsibilities:
Lead, coordinate, author, and review regulatory filing documents
Prepares FDA submissions and CE Mark Technical Documentation File, including 510(k) submissions, Device Master files, technical files, and post market surveillance, for product changes and/or new products as required to ensure timely clearance or approvals
Reviews clinical study documentation, including clinical protocols, informed consent, and clinical study recruitment materials
Collects documentation and coordinates with cross-functional teams to prepare regulatory submissions to regulatory agencies (or commercial partners)
Creates and maintains regulatory submission timelines and track deliverables to ensure company goals are met
Develop and execute company’s regulatory strategy in the US
Develops overall organizational regulatory and strategies
Provides strategic input and regulatory advice to project teams on development programs including new product development and changes to existing products
Conduct regulatory research and analysis
Keeps abreast of current regulatory landscape for medical device globally, e.g., 21st Century Cures Act and related FDA guidance documents, Medical Device Regulations (MDR), EU guidance documents, IEC 62304, AAMI TIR45, AGILE development, and etc
Familiar with Software as Medical Device (SaMD) and related regulations and guidance governing product development
Develops and communicates recommendations regarding new/emerging regulations to management and project teams
Identifies potential project issues proactively to allow implementation of appropriate regulatory strategies to mitigate risks
Interact with regulatory authorities
Represents the company and works directly with regulatory authorities on regulatory issues and submissions
Leads the preparation of responses to questions from regulatory authorities
Facilitates the preparation of meetings with regulatory authorities to support regulatory filings
Provide in-house training in quality / regulatory guidelines as applicable to team members
Supports international RA and QA efforts and collaborates with other teams across the company as needed
Manages and modifies a complete and comprehensive quality system to support development of Class II and Class III medical device products
Reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
Conducts on site audits of various products and processes and host regulatory agency audits as needed
Evaluates, authors and reviews SOPs, Guidelines and Work Instructions to ensure regulatory documents, submissions, and systems are well-controlled and comply with applicable regulations
Qualifications:
Regulatory and Quality experience
BS Degree or higher along with 5- 8 years of related work experience in Regulatory and/or Quality for medical devices and software
Demonstrated understanding of laws, regulations, standards, and guidance and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities
Experience in working with quality aspects of medical device and GMP in general, including implementation of FDA guidance on Cybersecurity Management and Software contained in Medical Device
Proven ability to successfully interact with regulatory authorities and manage major submissions and critical projects to meet deadlines
Proven track record and experience with regulatory submissions with a thorough understanding of FDA regulations
Preferred Qualifications
Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be a plus
RAC certification will be a plus
Experience in medical software development area is desirable but not required
Implementation of Regulatory/Quality along with medical device product development and manufacturing experience will be preferred
Prior working experience with FDA will be a plus.
Soft skills
Ability to manage and prioritize multiple tasks in a fast-paced environment while keeping with submission timelines
Self-motivated, well organized, detail oriented, and has excellent written and verbal communication skills
Works under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines
Strong leadership skills and experience, a team player, a fully engaged, hands-on professional capable of working collaboratively and independently
Computer technical skills
Experience with electronic submission building tools, document formatting and publishing standards
Experience using electronic document management system (EDMS)
Application Information & Contact (How to Apply)
Please apply by sending your resume to career@12sigma.ai
Learn more about 12 Sigma Technologies here