Job Overview: Seeking an experienced Director of Regulatory Affairs to join a dynamic Regulatory Affairs team in a hybrid role, with some onsite presence required at our Redwood City, CA offices.
San Francisco: Hybrid Schedule
Role Responsibilities:
- Lead and manage regulatory submissions (e.g., 510(k), PMA, IDE) in the U.S. and international markets, ensuring compliance with regulations and timely completion.
- Offer strategic regulatory guidance across teams (R&D, clinical, operations, legal, marketing) to align with regulatory requirements throughout the product lifecycle.
- Serve as the primary contact for regulatory authorities, handling communications including pre-submissions, Q-subs, and regulatory meetings.
- Oversee preparation and submission of post-market reports and filings to maintain compliance.
- Review product claims, labeling, advertising, and promotion to ensure adherence to FDA and international regulations.
- Partner with clinical teams on trial design and regulatory submissions to meet clinical regulatory standards.
- Assess preclinical, clinical, and manufacturing changes, identifying regulatory impacts and submission needs.
- Provide regulatory intelligence, updating teams on global regulatory changes and assessing their impact on products.
- Prepare cross-functional teams for interactions with regulatory authorities, including advisory and panel meetings.
- Develop regulatory policies to streamline processes and enhance compliance oversight.
- Manage relationships with external consultants, vendors, and notified bodies for submission processes and certifications.
- Communicate regulatory risks, strategies, and product impacts to senior leadership for informed decision-making.
- Train and mentor internal teams on regulatory compliance and keep leadership updated on regulatory changes affecting product development and market access.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field (advanced degree preferred).
- RAC certification required.
- Minimum 12 years of regulatory affairs experience in the medical device sector, including managing 510(k), PMA, and IDE submissions.
- Proven capability in presenting complex regulatory strategies and risks to senior leadership.
- Strong knowledge of FDA, EU MDR, and global medical device regulations, with experience in regulatory strategy.
- Experience in post-market activities for commercialized products.
- Solid background in regulatory submissions; PMA experience is highly preferred.
- Familiarity with international regulatory requirements.
- Strong project management, communication, and leadership skills with experience in leading cross-functional teams.
