Demo

Senior Regulatory Affairs Specialist

BioTalent Ltd
Agoura Hills, CA Full Time
POSTED ON 1/21/2025
AVAILABLE BEFORE 4/18/2025

Regulatory Specialist

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My client is seeking a Regulatory Specialist to join our growing team. As a Regulatory Specialist, you will play a crucial 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 :

  • B.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.
  • Hands-on EU MDR, APAC, and LATAM regulatory experience.
  • 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 My Client :

    My client 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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