Regulatory Affairs Specialist
4 weeks ago
We are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at EPM Scientific. This is an exciting opportunity to work with a leading medical device and diagnostics company, supporting their growing product portfolio.
Key Responsibilities:
- Develop and implement regulatory strategies for global product approvals
- Prepare and submit regulatory applications to FDA and international agencies
- Coordinate and compile regulatory submissions, including EU dossiers and PMA supplements
- Maintain annual licenses, registrations, and listing information
- Act as subject matter expert for audits and inspections with internal and external authorities
- Review and edit promotional materials
- Stay up-to-date with medical device regulations and ensure submission requirements are current and accurate
- Support product implementation by creating database licenses or reviewing/approving product release requests
Requirements:
- Minimum 5+ years of experience with Class II and/or Class III medical devices
- Experience authoring and submitting 510k applications and PMA supplements
- RAC Certification
- Experience with 21 CFR 820, ISO 13485, and relevant medical device directives
- Strong technical writing skills
- Familiarity with regulatory requirements for medical devices, including Quality Systems standards and clinical investigations
- Ability to travel 5%, including international travel
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