Senior Regulatory Affairs Manager
Apply NowCompany: BioTalent
Location: Sunnyvale, CA 94087
Description:
Position Overview
We are seeking an experienced Manager of Regulatory Affairs to lead and oversee regulatory strategies and submissions for our medical device and IVD products. This role requires a hands-on leader who thrives in a fast-paced environment, ensuring compliance with global regulatory requirements while supporting product innovation and market expansion.
Key Responsibilities
Qualifications
We are seeking an experienced Manager of Regulatory Affairs to lead and oversee regulatory strategies and submissions for our medical device and IVD products. This role requires a hands-on leader who thrives in a fast-paced environment, ensuring compliance with global regulatory requirements while supporting product innovation and market expansion.
Key Responsibilities
- Regulatory Strategy: Develop and implement regulatory strategies for new and existing products, ensuring alignment with business goals and global regulatory requirements.
- Submissions: Prepare, review, and submit regulatory documents, including 510(k)s, PMAs, Technical Files, Design Dossiers, and other regulatory submissions for FDA, EU MDR/IVDR, and other international markets.
- Compliance: Ensure products meet applicable regulatory standards, including ISO 13485, FDA QSR, EU MDR/IVDR, and other relevant regulations.
- Team Leadership: Manage and mentor a team of regulatory professionals, fostering professional growth and high performance.
- Cross-Functional Collaboration: Partner with R&D, Quality, Marketing, and other departments to support product development, labeling, and market access strategies.
- Risk Management: Assess and mitigate regulatory risks, keeping the leadership team informed of potential challenges and opportunities.
- Regulatory Intelligence: Stay up-to-date on changes in global regulatory requirements and communicate implications to relevant stakeholders.
Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field (Master's or advanced degree preferred).
- 5+ years of experience in regulatory affairs within the medical device or IVD industry.
- Proven track record of successful regulatory submissions (e.g., 510(k), PMA, CE Mark).
- Strong knowledge of global regulations, including FDA, EU MDR/IVDR, Health Canada, and other international requirements.
- Experience with Quality Management Systems (ISO 13485, FDA QSR).
- Excellent communication, leadership, and project management skills.
- RAC certification is a plus.