What are the responsibilities and job description for the Regulatory Compliance Specialist position at Bolt Medical?
Bolt Medical requires a Senior Quality Engineer to provide quality engineering support and leadership for Manufacturing Process development and implementation.
This role involves working closely with Manufacturing in the manufacture of disposable medical catheters in compliance with applicable regulatory and statutory requirements.
Main responsibilities include:
- Overseeing EO sterilization validation processes.
- Supporting environmental monitoring and clean room verifications.
- Reviewing and approving manufacturing validation test plans, protocols, and test reports.
- Leading the completion of risk management deliverables.
- Supporting and leading test method validation activities.
A strong understanding of GMP principles and experience working within ISO 13485, ISO 14976, and FDA 21 CFR Part 820 environments is essential.
