Regulatory Affairs Expert

23 hours ago


California, United States BioTalent Full time

Job Summary

We are seeking a highly skilled Regulatory Affairs Expert to join our team at BioTalent. As a key member of our regulatory team, you will be responsible for driving regulatory strategies and submissions for medical devices.

Key Responsibilities

  • Develop and Implement Regulatory Strategies: Collaborate with cross-functional teams to develop and implement global regulatory strategies for clinical applications in various markets.
  • Manage Regulatory Submissions: Oversee the preparation and submission of regulatory documents, including 510(k)s, PMAs, and IDEs, to FDA and international bodies.
  • Ensure Compliance: Collaborate with clinical and cross-functional teams to ensure compliance with regulatory requirements, including adverse event reporting.
  • Lead Technical File Preparation: Lead the preparation of technical files for CE marking and post-market regulatory activities.

Requirements

  • Education and Experience: Bachelor's degree in a related field; 5+ years of regulatory experience in the medical device or biotech industry.
  • Regulatory Knowledge: Strong knowledge of FDA regulations, EU MDR, ISO 13485, and experience with high-risk devices.
  • Communication Skills: Excellent communication skills and ability to work in a fast-paced, dynamic environment.
  • Travel Requirements: Ability to travel up to 10% (including international travel).

What We Offer

  • Competitive Compensation: Competitive salary ($105K - $130K), stock options, 401k, and health insurance plans.
  • Benefits and Perks: Paid time off, flexible schedule, wellness programs, and growth opportunities.

Our Commitment to Diversity

We are committed to diversity and providing equal employment opportunities to all individuals.



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