Regulatory Affairs Specialist - Medical Devices
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.
HRGO Recruitment offers permanent and temporary jobs across the UK
Required skills
- FDA
- Medical Devices
- Regulatory Affairs
- MDR
- ISO 13485
- MDD
- ISO13485
- MDSAP
Reference: 52808613
Please note Reed.co.uk does not communicate with candidates via Whatsapp, and we will never ask you to provide your bank, passport or driving licence details during the application process. To stay safe in your job search and flexible work, we recommend visiting JobsAware, a non-profit, joint industry and law enforcement organisation working to combat labour market abuse. Visit the JobsAware website for information and free expert advice for safer work.
Report this jobNot quite what you are looking for? Try these similar searches
Replace a job alert
Replace a job alert
Get Job Alerts straight to your inbox
"Office Assistant jobs in London"
Your Job Alert has been created and your search saved.
'Saved search name'