Regulatory Affairs Specialist Europe
Regulatory Affairs Specialist
Marlborough - Close to Swindon
£42,000 + Bens
The role incumbent will demonstrate the relevant talents for the role and will display the virtues aligned to principles:
Responsible for EU product submissions, license renewals, and periodic updates and registrations to regulatory agencies (FDA and EU regulatory entities). Organizes regulatory information (Design History Files and associated Technical Dossiers), tracking/control of submissions, review of labeling for compliance with regulatory filings, review product changes for impact on regulatory filings in the EU, and advisement to Senior Quality Management Staff of regulatory changes that impact the organization on an on-going basis. Represent Regulatory Affairs on R&D/Product Development project teams to ensure all regulatory requirements are met throughout the development process
Escalate process failures to Senior Management.
Essential experience/ qualifications:
- Knowledge of Corporate requirements, global Regulatory and Quality requirements for the manufacturer and marketing of drugs and medical devices
- Knowledge of Quality systems and manufacturing processes in medical device and pharma industries
- Demonstrated experience interfacing with FDA/Regulatory inspectors and customers during customer audits
- Strong Project Management, technical, analytical & problem solving skills.
- Ability to respond to customers in a timely manner
- Excellent verbal, presentation, and written communication skills.
Excellent interpersonal/communication/influencing/negotiation skills
- Ability to solicit feedback and information from others in an open environment.
- Ability to communicate effectively at all levels of the organization and influence accordingly
- Strong regulatory affairs working knowledge and experience with quality systems regulations and guidelines, ISO 13485, ISO 14971, GMP (21 CFR 820), Medical Device Directive (MDD), Medical Device Regulation (MDR and US FDA regulatory requirements.
- A minimum of 5 years’ relevant experience within the regulatory affairs discipline, including Medical Device, Biotechnology, and/or Pharmaceutical experience.
- Experience with Class II devices mandatory, Class III desirable
- Sound analysis, ability to prioritize acts and effectively direct others with a thorough understanding of Quality Management requirements & processes.
- Represents Regulatory Affairs on product life cycle management project teams to ensure all regulatory requirements are met throughout the development process
- Enforce a culture of compliance and performance to the quality management system and regulatory requirements.
- Complete submissions to FDA and EU regulatory entities as required
- Provide regulatory knowledge expertise to ensure compliance to all regulatory requirements and laws
Desirable skills/ experience/ qualifications:
- Good Laboratory Practices (21 CFR Part 58)
- Bioburden, Biocompatibility, and Microbiological Testing
- Lead Auditor
- ISO 13485 Audit
- Lean/Six Sigma
- FDA 510K Submissions
- Recall Experience
- Medical and Manufacturing Experience
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