Regulatory Affairs Manager
Location: Gloucester
Job Type: Permanent / Onsite
We are seeking a highly skilled Regulatory Affairs Manager to join our client, a global leading manufacturer in the medical device industry.
Role and Responsibilities
In this role, you will ensure business compliance, regulations, and quality standards are maintained to support the company's overall goal of maintaining correct market access for devices internationally.
* Stay up-to-date with 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)
* ISSUE 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
To be successful in this role, you will need:
* Proven experience within regulatory affairs, preferably in a managerial position
* Medical device experience is essential
* Lead auditor training
* MDR experience is strongly desirable
Benefits
We offer a competitive package including:
* 25 days annual leave + Bank Holidays
* Private health care options
* Employee assistance programmes
* Competitive pension scheme
Candidates who currently hold a Regulatory Affairs Manager, Compliance & Regulatory Affairs Manager, Regulatory Affairs Director, or Regulatory Affairs Specialist role may be suitable for this position.