Regulatory Affairs Specialist Lead

1 week ago


San Diego, California, United States BioTalent Full time

**Job Overview:**

BioTalent is seeking a highly experienced and skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our products with global regulations.

**Responsibilities:**

  • Regulatory Compliance: Ensure that all product registrations are compliant with applicable regulations in domestic and international markets.
  • Regulatory Projects: Lead multiple long-term projects, interacting with supervisors as required on activities, issues, or turning points.
  • Marketing Authorizations: Assess and document assessments of regulatory marketing requirements for global markets, schedule milestones, generate supporting documentation, and provide deliverables for assigned regulatory applications and renewals.
  • Maintaining Current Knowledge: Maintain current knowledge of applicable regulatory requirements and scientific issues in marketed geographies, monitor and analyze the development of new and emerging regulations, guidance, and standards.

Qualifications:

  • Education: Bachelor's degree in a life science, engineering, or equivalent required, advanced degree preferred.
  • Experience: Ten (10) years of work experience in the IVD or MD industry, of which five (7) should be Regulatory, experience in regulatory submissions including 510(k) and notified body technical documentation required.
  • Certifications: Regulatory Affairs Certification preferred.


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