About the Role
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This Regulatory Affairs Manager position requires an experienced professional to ensure business compliance with regulations and quality standards in support of the company's overall goal.
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Key Responsibilities
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* Maintaining accurate knowledge of both domestic and international regulatory requirements and effectively communicate this to management and project teams.
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* Ensuring the Quality Management System adheres to relevant regulations and quality standards, including ISO 13485, 21 CFR 820, MDD 93/42/EEC, and Regulation (EU) 2017/745.
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* Preparing and maintaining technical files, design dossiers, and other required documents for regulatory submissions and approvals.
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Qualifications and Experience
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* Prior experience within Regulatory Affairs, ideally in a senior role, with substantial involvement in the medical device sector.
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* Medical Device industry background is fundamental.
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* Lead Auditor certification is a significant advantage.
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Benefits
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* An attractive annual salary of £60,000-£70,000, commensurate with skills and experience.
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* Beneficial Leave entitlements, including 25 days annual leave + Bank Holidays.
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* Top-tier Private Health Care provision.
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* Employee Support Programmes.
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* A Comprehensive Pension Plan.
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