Job Description
Position: Regulatory Affairs Manager
Location: Gloucester
Job Type: Permanent / Onsite
Our client, a global leading manufacturer in the medical device industry are on the hunt for a Regulatory Affairs Manager.
Role and Responsibilities –
In this role, You will ensure business compliance, regulations and quality standards in support of the companies overall goal. This will be to maintain the correct market access for the device internationally.
Other responsibilities include:
* Maintain up-to-date knowledge on both domestic and International Regulatory requirements, effectively communicating to management and project teams.
* Support the process to ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements (including ISO13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745 and ISO14971)
* Issues advisory notices as required, in accordance to the MDD, MDR, and FDA regulatory requirements (21 CFR 803)
* Develop, prepare, and maintain high quality technical files, design dossiers and other necessary applications for regulatory submissions and approvals
Experience or Qualifications –
1. Proven experienc...