Job Overview
Omega Resource Group is seeking an experienced Regulatory Affairs Manager to ensure business compliance with regulations and quality standards in the medical device industry.
Responsibilities:
* Maintain up-to-date knowledge on domestic and international regulatory requirements, effectively communicating with management and project teams.
* Support the process to maintain the Quality Management System in accordance with ISO13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745, and ISO14971.
* Issue advisory notices as required, adhering to MDD, MDR, and FDA regulatory requirements (21 CFR 803).
* Develop, prepare, and maintain high-quality technical files, design dossiers, and necessary applications for regulatory submissions and approvals.
Requirements:
* Proven experience within regulatory affairs, preferably in a managerial position.
* Extensive medical device experience is essential.
* Lead Auditor training is desired.
* MDR experience is highly valued.
Benefits:
* 25 days annual leave + Bank Holidays.
* Private Health Care Options.
* Employee Assistance Programs.
* Competitive Pension Scheme.