How Remoteville checks and expires listings
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- 3 to 5 years relevant experience in a related field
- BS or BA degree
- Required experience with medical device development or pharmaceutical operations in a cGMP environment
- Understanding of change controls in a regulated industry
- Experience with project management
- Working knowledge of US EU and international medical device and pharmaceutical regulations
- Experience with Veeva Vault
- Ability to coordinate with team members vendors suppliers and contract manufacturers
Nice to have
- organized
- time management
- cross-functional coordination
- regulatory aware
- detail oriented
Day to day
- Coordinate and manage combination product change control records across product and manufacturing process changes.
- Initiate route and close design and development change records while maintaining design control documentation.
- Compile post-market surveillance information generate annual risk summaries and support risk management file updates.
- Support complaint investigations and serve as a central hub across cross-functional teams vendors suppliers and manufacturers to protect supply continuity.