Regulatory Affairs Expert

2 weeks ago


San Diego, California, United States BioTalent Full time
Job Overview

BioTalent is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global regulatory requirements and guiding the development of products through the regulatory approval process.

Key Responsibilities:
  • Design Control: Collaborate with cross-functional teams to provide strategic guidance on global regulatory requirements and implement required regulatory actions.
  • Regulatory Projects: Lead multiple long-term projects, interacting with supervisors as needed, and model effective team dynamics behavior.
  • Marketing Authorizations: Assess and document regulatory marketing requirements for global markets, schedule milestones, and generate supporting documentation.
  • Maintain current knowledge of applicable regulatory requirements and scientific issues in marketed geographies.

Requirements:
  • Bachelor's degree in a life science, engineering, or equivalent required; advanced degree preferred.
  • Regulatory Affairs Certification preferred.
  • Ten (10) years of work experience in the IVD or medical device industry, with five (7) years in regulatory roles.
  • Experience in regulatory submissions, including 510(k) and notified body technical documentation.
  • International registrations experience required.

Skills and Qualifications:
  • Advanced knowledge of in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations.
  • Ability to interpret and apply regulations, with knowledge of electronic publishing/file management systems.
  • Advanced verbal and written communication skills, including proofreading, scientific writing, presenting positive persuasive arguments, and presentation to various organizational levels.
  • Leadership, influence, and negotiation skills, with the ability to build collaborative relationships.


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