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Regulatory Affairs Specialist Salary: Attractive, with excellent benefits Location: Bishops Stortford, Essex/Herts Border A global medical device company seeks a Regulatory Affairs Specialist to ensure compliance across its global operations. You will support regulatory submissions, maintain technical files, and offer expert advice on design projects. Key Responsibilities: Regulatory Compliance: Stay updated on global medical device regulations, support compliance throughout the group, and interact with stakeholders. Task Completion: Complete tasks per regulations, report quality defects or potential risks. Professional Development: Update professional knowledge through courses and relevant literature. Product Approvals: Support the regulatory team in product approvals to facilitate sales of medical devices in domestic and foreign markets. Audit and Documentation: Support internal and external audits to demonstrate compliance with ISO 13485, UK MDR 2002, MDR 2017/745, MDD 93/42/EEC, MDSAP, and other related legislation. Prepare and maintain necessary QMS and regulatory documentation across the Group. Facilitate regulatory improvement initiatives CAPA Investigations: Conduct investigations and review customer complaints for vigilance. Key Tasks: Maintain compliant processes, review technical documentation, prepare regulatory submissions, coordinate risk files, analyse post-market data, and support CAPA and FSCA actions. Core Competencies: Experience: 5 years in the medical device industry, familiar with ISO 13485 and global regulations. Knowledge: Hands-on with medical device ISO standards, EU, UK, and FDA regulations; knowledge of ophthalmology and SaMD is a plus. Environment: Experience in medical device production/manufacturing. Technical Files: Create and maintain Technical/Design History Files per UK, EU, and US regulations. Risk Management: Knowledge of ISO 14971 principles. Problem Solving: Practical approach to problem-solving. Team Collaboration: Self-motivated, effective in cross-functional teams. Project Management: Ability to manage multiple projects. Regulatory Adherence: Manage stressful situations and influence regulatory outcomes. Communication Skills: Excellent verbal and written skills able to convey complex concepts clearly to co-workers, internal teams, distributors, regulatory bodies, authorities, and stakeholders. Adaptability: Flexibility to changing regulations. Meticulousness: Attention to detail in reviewing documents and ensuring compliance. IT Skills: Knowledge of ERP Systems and Microsoft 365 is beneficial. GMP & GDPR: Understanding of GMP & GDPR requirements. Benefits: 25 days holiday plus bank holidays Pension scheme (Company 7.5%, Employee 4.8%) Life Assurance and Long-Term Disability Insurance Location: Bishops Stortford, Essex/Herts Border Work remotely 2 days a week. Easily accessible, with free car parking near the M11/Stansted Airport junction. HRGO Recruitment offers permanent and temporary jobs across the UK