Regulatory Affairs Specialist

  • Salary: Up to £40,000
  • REF Number: 00052353
  • Consultant: Andy Leake
  • Contact: 01438 842 966
  • Date Published: 14.12.2021
  • Closed Date: 25.03.2022
  • Industry: Medical Devices, Healthcare
  • Location: Cambridge, UK, East Anglia
  • Functional Expertise: Regulatory Affairs

CK Group are recruiting for a Regulatory Affairs Specialist to join a global healthcare company. The role will work within Medical Devices and will support the regulatory activities across Europe. This will be based in Cambridge with some home working offered.

Principal Regulatory Affairs Specialist Role:

  • Support the planning, implementation, execution, and maintenance of regulatory compliance for new and existing EU Medical Devices, including Drug-Device Combination products.
  • Supportinnovative Device Development.
  • Support regulatory intelligence and policy monitoring activities.

Your Background:

  • At least a Degree in a scientific discipline.
  • Proven experience in Medical Device regulatory affairs, leading developmentactivities.
  • In-depth knowledge of relevant regulations: MDD, MDR, ISO 13485.
  • Experience with Drug-Device Combinations MAAs and CE marking applications.

Apply: It is essential that applicants hold entitlement to work in the UK. For more information or to apply for this Regulatory Affairs Specialist position, please contact Andy Leake on 01438 842966 or email aleake@ckgroup.co.uk. Please quote reference 52353.uired:

  • You hold a Masters degree (ideally a PhD) in Epidemiology, Outcomes Research or other relevant scientific discipline, and have a track record of publications in high-caliber peer-reviewed journals.
  • Experience in having successfully delivered global and/or local RWE projects from conceptualisation to publication within the pharmaceutical industry (or with a recognised expert consultancy or academic centre of excellence), using primary as well as secondary data, such as large healthcare databases.
  • Hands-on experience in working across internal stakeholder functions (e.g., medical affairs, market access, clinical development, etc.) to develop the optimal RWE strategy and tactical plan to support an asset within a specific disease area or focus.
  • Combination of strong methodological quantitative knowledge, strategic, innovative thinking, and communication skills.

Apply: For more information or to apply for this RWE Scientist position, please contact Sam Cupit on 01246 457733 or email scupit@ckgroup.co.uk, quoting job ref 52355.

It is essential that applicants hold entitlement to work in the UK.y work in a dynamic environment.

Apply: Entitlement to work in the UK is essential. For more information or to apply for this Global Clinical Operations Leader position, please contact Jim Gleeson on 01438 842973 or email jgleeson@ckclinical.co.uk. Please quote reference 52357.utcomes, retrospective and prospective data analyses, registry, epidemiology or health services research

  • Expert insight and knowledge in Health economics and model development
  • Skilled in translating complex economic concepts into simple language.
  • Good understanding of current UK health care system and market access issues
  • Demonstrated experience of project management
  • Strong numeric skills
  • Scientific/medical knowledge
  • A commercial mindset

Apply: Entitlement to workin the UK is essential. For more information or to apply for this Health Economics Manager position, please contact Steve Lord on 01246 457733 or email slord@ckgroup.co.uk. Please quote reference 52358 in all correspondence.

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