Regulatory Affairs Lead

2 weeks ago


San Diego, California, United States Werfen Full time
Job Summary

The Staff Regulatory Affairs Specialist plays a pivotal role in ensuring the company's products meet global regulatory requirements. This key position involves product registrations, acting as the company representative with regulatory authorities, and representing Regulatory Affairs on product development teams.

Duties and Responsibilities
  • Design Control: Provide strategic guidance on global regulatory requirements to support product marketing authorizations, review product design and change documentation, and perform regulatory assessments.
  • Regulatory Projects: Independently lead multiple long-term projects, interact with manager as required, and model effective team dynamics behavior.
  • Marketing Authorizations: Assess and document regulatory marketing requirements for global markets, schedule milestones, generate supporting documentation, and provide deliverables for assigned regulatory applications and renewals.
  • Regulatory Intelligence: Acquire and maintain current knowledge of applicable regulatory requirements and scientific issues in marketed geographies, monitor and analyze the development of new and emerging regulations, and coordinate evaluation of new and emerging standards with Subject Matter Experts.
Requirements
  • Bachelor's degree in a life science, engineering, or equivalent required, advanced degree preferred.
  • Minimum 6 years of experience in Regulatory Affairs, of which a minimum of 4 years must be in IVD Regulatory Affairs.
  • Regulatory Affairs Certification preferred, experience in regulatory submissions including 510(k) and IVDR technical documentation required.


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