Regulatory Affairs Specialist
4 days ago
Job Title: Principal Regulatory Affairs Specialist
About the Role:
EPM Scientific is seeking a highly skilled Principal Regulatory Affairs Specialist to support the growth of our medical device and diagnostics portfolio. As a key member of our regulatory team, you will play a critical role in ensuring compliance with FDA and international regulations.
Key Responsibilities:
- Act as the regulatory representative on core product development teams, providing input on FDA and international product registrations and licensing requirements.
- Develop global strategies for new and modified products, ensuring compliance with regulatory requirements.
- Prepare and submit PMA and IDE submissions and supplements, as well as international product registrations and licensing applications.
- Maintain licensing, registration, and listing information, ensuring accuracy and compliance.
- Support the product release process by creating GTS licenses, ensuring timely and compliant product launches.
- Review and advise on labeling, product claims, and ad promo brochures, ensuring regulatory compliance.
Requirements:
- Minimum 5+ years of experience in Regulatory Affairs, with at least 3 years working directly on class III medical devices.
- Must have 510k and PMA submission experience.
- RAC Certification.
- Experience working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
- Experience with medical device software requirements and software regulations.
What We Offer:
EPM Scientific offers a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to apply.
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