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Medical Device Product Development Specialist
1 week ago
- Collaborate with cross-functional teams to design, develop, and maintain software applications intended for use as medical devices.
- Work closely with regulatory affairs to ensure software products meet all necessary regulatory requirements and obtain required certifications and approvals.
Key Responsibilities include ensuring software design complies with relevant medical device regulations and standards (e.g., IEC 62304, ISO 13485). The successful candidate will also prepare and maintain documentation required for regulatory submissions and audits.