What are the responsibilities and job description for the Senior Engineering Regulatory Specialist position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- Maintain up-to-date knowledge of medical device regulations (IEC 60601, ISO 14971, UL, TUV, FDA).
- Develop and execute test protocols for electrical, system, and software tests.
- Monitor and assess product compliance with evolving standards.
- Update and maintain technical documentation.
- Provide technical input during design and development.
- Educate and collaborate with team members on regulatory standards.
Requirements :
