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Regulatory Affairs Manager

2 months ago

United Kingdom Advanced Resource Managers Full time
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.

Key Responsibilities

- 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.

Required Skills:

- 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 teamwork, establishing strong relationships, and communicating effectively with clients globally.
- Demonstrated efficiency in time management.

Experience:
 

- Extensive international exposure, particularly in complying with US/EU regulations, within the realm of Combination Products.
- Proficient in creating and enhancing Design History Files for Combination Products.
- Skilled in overseeing the lifecycle of Medical Devices and Combination Products.
- Familiarity with the functionality of the Veeva Vault document management system.

Management Role:
No people management responsibility, this role is project based.

The company provides a competitive salary for this full-time, permanent position. Candidates have the option to be located in the UK, Portugal, Estonia, or Slovakia for this role.

If you are interested in hearing more details on this role please send a copy of your CV over to vik.patel@arm-talent.com