Regulatory Affairs Specialist

7 days ago


Los Angeles, California, United States BioTalent Full time
Regulatory Affairs Specialist

BioTalent is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a critical role in ensuring our medical devices comply with global regulations.

Key Responsibilities:

  • Develop and implement regulatory strategies to obtain timely approvals from worldwide regulatory bodies.
  • Prepare and submit regulatory submissions for new products and product changes.
  • Review protocols and reports to support regulatory submissions.
  • Maintain proficiency in global quality and regulatory requirements.
  • Provide regulatory input to product lifecycle planning.
  • Support clinical studies and regulatory documentation.

Qualifications:

  • Bachelor's degree in a related field (biomedical, biotechnology, regulatory sciences).
  • 3-5 years of experience in International Regulatory Affairs, preferably in the Medical Device industry.
  • Experience with Class II medical devices, including implants.
  • Knowledge of ISO 13485 and ISO 14971 standards.

Preferred Qualifications:

  • Experience with clinical studies.
  • Strong project management and problem-solving skills.
  • Experience with medical device software regulations.
  • Regulatory Affairs Certification (RAC).

About BioTalent:

BioTalent is a growth stage medical device company dedicated to improving the quality of life for women.

Benefits:

  • Competitive compensation
  • Comprehensive benefits package
  • Unlimited vacation
  • Paid maternity leave
  • 401(k) with matching contributions


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