About the job
About Spectrum Vascular
Spectrum Vascular is a pioneering medical device firm dedicated to enhancing vascular access and medication management. Our mission is to improve patient outcomes globally by equipping caregivers with high-quality, innovative products and exceptional customer service. Formed through the integration of a trusted portfolio of widely used products, innovation remains a strategic pillar of our journey. Our designs focus on delivering antimicrobial and antithrombogenic protection, catering to critical care and pediatric patient needs. This role offers a unique chance to join a dynamic team with established products and an entrepreneurial spirit.
Role Overview:
The Regulatory Affairs Specialist plays a crucial role in supporting global regulatory submissions and ensuring compliance for medical device products throughout their lifecycle. This position requires collaboration with Quality, Engineering, Clinical, and Manufacturing teams to effectively prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.
- Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation, Health Canada, and other global filings).
- Maintain regulatory files, declarations of conformity, and device registrations.
- Respond to regulatory agency requests for additional information (AIs, deficiency letters, technical queries).
- Support U.S. and EU market approval processes, ensuring adherence to regulatory standards.
- Assist with post-market submissions (progress reports, annual reports, etc.).
- Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers.
- Communicate with distributors concerning information requests, regulatory inquiries, and support for regulatory filings.
Compliance & Quality System Support
- Collaborate with Quality Assurance to maintain compliance with relevant regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.
- Participate in internal audits, management reviews, and preparations for external audits as necessary.