Regulatory Affairs Manager
Location: Remote
Compensation: To Be Discussed
Staff Reviewed: Fri, Oct 25, 2024
This job expires in: 22 days
Job Summary
A company is looking for a Regulatory Affairs Manager to oversee regulatory initiatives for implant and prosthetic solutions.
Key Responsibilities:
- Develop and implement regulatory strategies for global medical device clearances and approvals
- Manage regulatory submissions and communications with FDA and EU notified bodies
- Provide regulatory guidance to cross-functional teams throughout the product lifecycle
Required Qualifications:
- Bachelor's degree in life sciences, regulatory affairs, or a related discipline
- 5+ years of experience in regulatory affairs, preferably in the medical device industry
- In-depth knowledge of FDA and international regulations (e.g., EN ISO 13485, EU MDR)
- Regulatory Certification (such as RAC) or a Master's degree in a scientific discipline is a plus
- Proficiency with regulatory software and Microsoft Office Suite
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