Regulatory Affairs Manager

Omega; Gloucester; On-site; GBP 45,000 - 75,000; Full time

Job summary

A forward-thinking company is seeking a Regulatory Affairs Manager to ensure compliance and quality standards in the medical device industry. This role involves maintaining market access for devices, supporting the Quality Management System, and developing high-quality regulatory submissions. The ideal candidate will have extensive experience in regulatory affairs, particularly within the medical device sector, and will be responsible for communicating regulatory requirements effectively. Join a dynamic team where your expertise will contribute to the success of innovative medical solutions, ensuring that the highest standards of quality and compliance are met.

Benefits

25 days annual leave + Bank Holidays

Private Health Care Options

Employee Assistance Programmes

Qualifications

• Proven experience in regulatory affairs, especially in managerial roles.
• Strong knowledge of medical device regulations and quality systems.

Responsibilities

• Ensure compliance with international regulatory requirements.
• Maintain Quality Management System according to relevant standards.
• Develop and maintain technical files for regulatory submissions.

Skills

Regulatory Affairs Management

Quality Management Systems

ISO Standards (ISO13485, ISO14971)

Medical Device Regulations

Lead Auditor Training

Education

Experience in Regulatory Affairs

Medical Device Experience

Job description

Omega Gloucester, England, United Kingdom

Regulatory Affairs Manager

Our client, a global leading manufacturer in the medical device industry, is 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 company's 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).
• Issue advisory notices as required, in accordance with 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 –

• Proven experience within regulatory affairs with an extensive amount being in a managerial position.
• Medical device experience is essential.
• Lead Auditor training.
• MDR experience strongly desirable.

Benefits –

• 25 days annual leave + Bank Holidays.
• Private Health Care Options.
• Employee Assistance Programmes.

For more information regarding this Regulatory Affairs Manager role, please contact Ben Herd on 01453 829523 or [e-mail].

Omega Resource Group is acting as an Employment Agency in relation to this vacancy.

Seniority Level: Mid-Senior level

Employment Type: Full-time

Job Function: Quality Assurance, Manufacturing, and Engineering

Industries: Industrial Machinery Manufacturing, Medical Equipment Manufacturing, and Manufacturing