Regulatory Affairs Specialist - Medical Devices

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.

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