Title: Principal Regulatory Affairs Specialist
A leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products.
Responsibilities:
- Act as the regulatory representative on core product development teams and provide input related to FDA and international product registrations and licensing requirements
- Develop global strategies for new and modified products
- Prepare and submit PMA and IDE submissions and supplements
- Compile and submit international product registrations and licensing applications
- Maintain licensing, registration, and listing information
- Support the product release process by creating GTS licenses
- Review and advise on labeling, product claims, and ad promo brochures
Qualifications
- 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 of 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
