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Regulatory Affairs Specialist - Medical Devices in Wiltshire

Regulatory Affairs Specialist – Medical Devices

Our client is a medical devices company that develops a range of specialist wound care products. They are seeking a regulatory affairs professional to join their team.

Role overview:

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.

Enforce a culture of compliance and performance to the quality management system and regulatory requirements.

Provide regulatory knowledge expertise to ensure compliance to all regulatory requirements and laws.

Candidate:

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), Canadian Medical Device Regulations (CMDR), Therapeutic Goods Administration, Australia (TGA) 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.

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.

Project Management, technical, analytical & problem solving skills. Excellent verbal, presentation, and written communication skills.

Desirable skills:

GLP (21 CFR Part 58).

Bioburden, Biocompatibility, and Microbiological Testing.

Lead Auditor qualified.

ISO 13485 Auditor.

Lean/Six Sigma.

FDA 510K Submissions.

Product Recall Experience.

Medical and Manufacturing Experience.

Reference

SH-RAMD

Location

Wiltshire
Wiltshire

Salary

£35,000 to £50,000
£35 to 45k

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