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Regulatory Affairs Manager
2 months ago
Regulatory Affairs Manager CMC (combination device) Fully remote
I am presently looking for a skilled Regulatory professional in the CMC combination device field for a long-term client. Depending on your experience, my client is open to considering candidates from Lead level to Associate Director.
Develop and maintain top-notch Design History Files to ensure regulatory compliance for inhaled and injectable combination products.
- Update Design History Files for Combination Products based on current US and EU regulatory standards.
- Aid in creating General Safety and Performance Requirements (GSPR) checklists for devices.
- Support in planning regulatory strategies for Combination Product submissions.
Proficient in regulatory affairs for Medical Devices and Combination Products in CMC.
- Proven capability to concentrate on tasks with precision and retain essential data.
- Skilled in overseeing the lifecycle of Medical Devices and Combination Products.
- No people management responsibility, this role is project based.
The company provides a competitive salary for this full-time, permanent position. patel@arm-talent.
