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Regulatory Affairs Professional

1 month ago

Gloucester, Gloucestershire, United Kingdom Omega Resource Group Full time
Job Title: Regulatory Affairs Professional

Company Overview: Our client, a global leading manufacturer in the medical device industry, is seeking a skilled Regulatory Affairs Professional to ensure business compliance with regulations and quality standards.

Estimated Salary: £60,000 - £80,000 per annum,

Job Description: As a Regulatory Affairs Professional, you will be responsible for maintaining up-to-date knowledge on domestic and international regulatory requirements, effectively communicating with management and project teams. You will also support the process to ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements, including ISO 13485, 21 CFR 820, MDD 93/42/EEC, and Regulation (EU) 2017/745.

Required Skills and Qualifications: Proven experience within regulatory affairs, with an extensive amount being in a managerial position, medical device experience is essential, lead auditor training, and proficiency in communication and teamwork.

Benefits: Competitive pension scheme, private healthcare options, employee assistance programmes, and 25 days annual leave plus bank holidays.