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Senior Regulatory Affairs Specialist
- Posted 07 January 2025
- LocationAgoura Hills
- Job type Permanent
- Reference209166
- Contact NameJeremy Burling
Job description
Regulatory Specialist
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:
My client is a growth stage medical device company dedicated to improving the quality of life for women.
Benefits:
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.
- 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.
- Experience with clinical studies.
- Strong project management and problem-solving skills.
- Experience with medical device software regulations.
- Regulatory Affairs Certification (RAC).
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
