Regulatory Affairs Director
4 days ago
Are you a seasoned professional in regulatory affairs looking for a challenging opportunity to lead a team and drive business growth?
We are seeking an experienced Regulatory Affairs Manager to join our client's manufacturing organization in Gloucester, UK. As a key member of the leadership team, you will be responsible for ensuring business compliance with relevant legislation and quality standards.
The successful candidate will have a strong background in medical devices and experience in managing regulatory affairs teams. You will be required to maintain current knowledge of domestic and international regulatory requirements and communicate this information effectively to management and project teams.
Key responsibilities include maintaining the Quality Management System in alignment with ISO 13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745, and ISO 14971. You will also be responsible for issuing advisory notices as necessary, developing high-quality technical files, and preparing documentation for regulatory submissions and approvals.
We offer a competitive salary package, including 25 days holidays plus bank holidays, pension, and single Vitality Healthcare upon successful completion of the probationary period. Our company is committed to equality and diversity, and we welcome applications from all qualified candidates.
Please note that this job description is intended to provide a general overview of the role and responsibilities. For more information, please visit our website or contact us directly. Estimated salary range: £60,000 - £80,000 per annum depending on experience.
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