CPI Selection

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





Key Responsibilities:



  • Represent Regulatory Affairs for EU sites on product lifecycle development teams to ensure that all regulatory requirements are met throughout the development process

  • Updates and maintains all Design History Files and associated documents

  • Completes submissions to EU and FDA regulatory entities as needed

  • Creates and maintains product EU Technical Files

  • Collects and coordinates information and preparation of regulatory documentation for submissions to regulatory agencies and advise on the submission strategy

  • Maintains regulatory files/database and chronologies in order

  • Establishes and maintains a tracking system for changes in documents submitted to agencies and/or customers

  • Supports the sites in the timely renewal of certificates, licenses, and registrations

  • Audits and ensures standardization of all Product Technical Files.

  • Assist in creation and approval of product labelling, TDS, MSDS, and instructions for use (IFU)

  • Review and provide regulatory oversight for marketing literature for compliance with relevant regulatory requirements

  • Provide the regulatory review of customer complaints and define their regulatory report ability as needed in post market surveillance activities

  • By utilizing regulatory knowledge and expertise, provide support and expansion of the Regulatory Services function as part of the Product Life Cycle Management (PLM) process to customers

  • Maintain current knowledge of MDD, MDR, FDA and international regulations with guidance and standards applicable to products

  • Participate in research of regulatory issues and dissemination of regulatory information to Production, QA, QC, R&D department, and Senior Quality Management

  • Execute compliance GAP audits with remediation plans at EU sites

  • Support the acquisition of monthly regulatory quality metrics and KPIs.

  • Monitor CAPA activities for key accounts internally and externally.

    Escalate process failures to Senior Management.


  • Perform other activities as required.





  • Essential experience/ qualifications:



    Essential Experience:


    • 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

      Essential Qualifications:

    • 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.

      Essential Skills:

    • 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






    • Start: asap
    • Duration: Permanent
    • Rate: £40k - 42k per year
    • Location: Marlborough, Wiltshire, England
    • Type: Permanent
    • Industry: Medical
    • Recruiter: CPI Selection
    • Contact: Anneka Local
    • Email: to view click here
    • Reference: AWQA
    • Posted: 2019-07-11 20:47:05 -

    • View all Jobs from CPI Selection


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