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BioTalent

Senior Regulatory Affairs Manager

BioTalent, San Jose

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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
  • 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
  • Bachelors degree in Life Sciences, Engineering, or a related field (Masters 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.

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