Principal Regulatory Affairs Specialist
Tandem Diabetes Care
- San Diego, CA
- $144,000-165,000 per year
- Permanent
- Full-time
- Provide strategic product direction to product teams and cross functional partners to advise on global medical device regulation. Interprets Medical Device regulations, with a particular emphasis on Digital Health, Software as a medical device (SaMD), Cybersecurity, AI/ML enabled devices and provide direction to product teams in understanding the impact of such regulations on existing and new Digital Health products and solutions.
- Identify gaps in product development plans that may pose regulatory issues and come up with novel development strategies.
- Evaluate proposed engineering, manufacturing, labeling and quality system changes and perform global regulatory impact assessment for regulatory filings and approvals.
- Ensuring data privacy and security plans are aligned with corporate quality system, regulatory requirements, and digital health regulatory models and initiatives.
- Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
- Serves as a lead on product design/development and sustaining engineering project teams.
- Acts as Tandem representative in FDA and other regulatory inspections as needed.
- Reviews and Complete US and OUS submissions as directed; liaising with the health authorities as needed.
- Reviews and analyzes project and customer requirements and assists project teams in tailoring and using regulatory procedures, methods, templates and tools.
- Bachelor’s degree in Science, Regulatory Affairs, Technology, Engineering, or Mathematics, Pharmacy or equivalent combination of education and applicable job experience.
- 11+ years of related experience with a Bachelor’s degree; or 8+ years and a Master’s degree; or a PhD with 5+ years of experience in regulatory function in medical device or health IT industry.
- Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.
- Demonstrated experience in leading, designing, writing, and submission of regulatory filings and correspondence and/or approvals, including experience authoring a range of global regulatory submissions, (e.g., 510(k), De Novo, CE Mark etc.) and preparing regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International registrations).
- Proficient knowledge of quality standards: ISO 9001, ISO 13485, ISO 14001, ISO 11137, 21CFR Part 820 and other appropriate industry standards.
- Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
- Significant experience with products containing software, including knowledge of the software life cycle.
- Working knowledge of IEC 60601-series standards, specifically IEC 62304.
- Prior experience with SaMD, MDDS, AI/ML, non-SaMD, and Digital Healthcare.
- Ability to translate and simplify technical content or regulations and communicate to stakeholders.
- Strong understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies globally for diagnostic/digital health tool development and approval, with particular focus on US, Canada, and EU/UK.
- Anticipates business and regulatory issues; recommends product, process, or service improvements. Fosters ongoing awareness of developments in technology within the team.
- Demonstrated experience communicating with regulatory agencies including FDA, Health Canada, and EU regulatory agencies.
- Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the product development and commercialization process.
- Ability to recognize non-conformances from accepted and documented practices.
- Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
- Skilled at creating a cooperative team environment.
- Ability to dive into details, translate and statistically analyze data, and effectively report results through written and/or graphical formats.
- A positive approach to people and problem solutions along with a strong sense of discretion and the ability to maintain confidentiality.