The Sr. Manager, Regulatory Affairs will oversee activities pertaining to successful pre-market development, new and continuing market entry, and post-market surveillance.
The right candidate will possess outstanding operational experience and skills including the demonstrated ability to creatively apply regulatory requirements to applicable (and innovative) processes. He/she will be responsible for working cross-functionally at all levels of the organization to support an agile development environment and ensure regulatory compliance.
This position is responsible for all activities related to regulatory approval to market devices. From development practices to post-market surveillance. He/she will be responsible for the assessment of device changes for regulatory impact and develop strategies for submissions and maintenance of documentation within the shifting framework of regulatory requirements worldwide in an efficient manner. He/she will establish strategic plans and procedures at all levels to ensure that the company fulfills its obligations under FDA and international regulations for medical device manufacturers, including reporting and post-market surveillance as applicable.
We have a talented regulatory team and a strong team culture of respect and collaboration; the right candidate will contribute to this culture and continue to build upon it. #LI-IB;
Job Responsibilities:
- Manage worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and market release. Review significant regulatory strategies with leadership team, as necessary, and negotiate submission steps with regulatory bodies.
- Keep informed of new regulations and requirements as they relate to continued compliance and interpret for regulatory education and guidance within the organization. Collaboration with key internal partners and other key stakeholders to support a globally effective and compliant organization.
- Prepare regulatory strategies/plans and worldwide requirements lists. Provide on-going support to core and project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations.
- Effectively monitor and ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines.
- Ensure all reporting requirements to external regulatory authorities are completed accurately and on time.
- Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling, promotional materials, changes to existing devices and documentation, including review of training, promotional and advertising pieces.
- Provide business and product information to enable development/strategies/requirements and communication of information to leadership team.
- Provide support as backup for the Person Responsible for Regulatory Compliance.
- Establish/maintain good relationships with regulatory authorities.
Skills Needed:
- Deep knowledge and understanding of worldwide product regulation/registration pathways, medical device regulations and applicable standards, including but not limited to ISO 13485, ISO 14971, IEC 62304, FDA CFR 21 parts 803 - 820, EU MDR (2017/745), Canadian Medical Devices Regulations, PMDA.
- Experience working with regulated software medical device, including application of 62304 and an agile/scrum development environment.
- Successful domestic and international regulatory submission track record. Skilled at preparing, reviewing, editing, filing, and supporting various types of submissions. including original and supplemental Investigational Device Exemptions (IDEs), Premarket Notifications w/ clinical data, and CE Design and Technical Dossiers.
- Utilizes knowledge of the regulatory requirements to support regulatory resources in determining the best risk management position to take on various issues. Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
- Good common sense approach and sound judgement when creating value through compliance. Approachable and able to interact and influence effectively at technical and management levels.
- Incredible team management skills, ability to lead, train and mentor team members at all levels. Excellent team player with ability to find and create consensus, and adept at working in the fast pace of a startup environment.
- Excellent verbal and written communications skills evidenced by short approval times for product submissions and successful interactions with colleagues, consultants, and various regulatory agencies worldwide.
- Direct experience with external audits/inspections both general audits for compliance and pre-approval inspections for product registrations/submissions.
- Demonstrated ability to independently assess risk and develop imaginative, thorough, and practical solutions to critical and difficult problems that are consistent with organizational objectives.
- Strong problem-solving skills. Ability to analyze a wide range of information, including conflicting and ambiguous inputs and propose solutions.
- Complete understanding and wide application of technical or regulatory principles, theories, and concepts. General knowledge of other related disciplines.
Educational Requirements & Work Experience:
- Bachelor’s Degree
- 8+ years regulatory medical device experience, including 5+ years management experience
- 5+ years working with software as a medical device, extreme familiarity with current regulatory thinking around software and AI
The pay range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to experience and training; skill sets; licensure and certifications; and other business and organizational needs. A reasonable estimate of the base salary compensation range is $170,000 to $220,000 per year (the higher end of the range is solely reserved for San Francisco Bay Area applicants), cash bonus, and stock options.
