Teams at Spectrum Vascular

The Regulatory Affairs Specialist supports global regulatory submissions and compliance, ensuring medical devices meet regulatory requirements throughout their lifecycle. Responsibilities include preparing filings, maintaining regulatory documents, collaborating with cross-functional teams, and supporting market approval processes.

The Regulatory Affairs Manager develops and implements regulatory strategies for product registrations, ensures compliance with regulations, and handles regulatory submissions and documentation for medical devices.

Receive, document, investigate, and resolve medical device product complaints per FDA, ISO 13485, and EU MDR. Coordinate cross-functional investigations, communicate with HCPs and regulators, submit regulatory reports, support CAPA and PMS, maintain complaint records, and prepare trend analyses.