Job description
Provide support for new product development and transform the on-market product development documentation in alignment with the latest regulatory requirements.
Must have EU MDR experience.
Focus on improvement of the technical files and risk management documentation including reviewing product/manufacturing process changes, supplier changes, new and revised engineering protocols, and reports, and reviewing product labeling.
Ensure compliance with the design control process and with the Quality Management System.
Mentor more junior Regulatory employees.
The position will work closely with the R&D/Engineering group as well as QA/RA.
BS or BE in a relevant science or engineering discipline.
Must possess knowledge of domestic (FDA) and foreign regulatory requirements for the manufacture and distribution of medical devices (especially design control and technical file compilation).
Job Type: Full-time
Salary: $100,000.00 - $1,100,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to commute/relocate:
- Billerica, MA 01821: Reliably commute or planning to relocate before starting work (Required)
Experience:
- EU MDR: 2 years (Preferred)
Work Location: One location
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