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Head of Regulatory Affairs

Job LocationCambridge
EducationNot Mentioned
Salary£100,000 - £120,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Head of Regulatory AffairsCambridge£100k - £120k (dep on exp) + excellent benefits! One of the UK`s most truly exciting high technology companies is looking for a highly experienced and driven Head of Regulatory Affairs to join their team. As the Head of Regulatory Affairs, you will apply your passion for detail and excellence to help delivery of their ground-breaking medical devices!As a key member of the companys senior management team and reporting to the Operations Director; you will provide vision, leadership, support, collaboration and direction that ensures the systems and instruments are delivered to the highest standard adhering to the highest of regulatory standards. Working closely with the Quality and Manufacturing teams, you will take a hands-on approach to leading the international regulatory compliance function of the business.This is a fantastic opportunity for a Head of Regulatory Affairs from an ultra-high quality, safety critical/highly regulated industry background to come into a superbly financed organisation and implement a world class Regulatory strategy to achieve the strategic operational goals - making a critical impact on the success of the entire business!Requirements for the Head of Regulatory:

  • Experience in the medical device industry with specific experience of requirements of MDD/MDR; US FDA
  • Good working knowledge of risk management (ISO 14971) and GMP/ISO 13485
  • Strong interpersonal, collaboration and negotiation skills
  • Good experience of mentoring and developing teams, having successfully led small teams in the past
  • Ability to build strong relationships between the Regulatory team and other areas of the organisation whilst communicating effectively at all levels.
  • A detailed understanding of what it takes to ensure regulatory compliance in a manufacturing and medical device business.
  • Strong attention to detail and the ability to multi-task and balance competing priorities within an ever-changing high-tech organisation.
  • Does this sound like you or someone you knowIf so, please get in contact with Darren Holmes of Vector Recruitment Ltd on or Required skills
  • GMP
  • ISO
  • Regulatory Affairs
  • MDR
  • compliance
  • medical devices
  • ISO 14971
  • document control
  • MDD
  • regulations
  • class 3
  • USA regulations
  • document regulations FDA
  • Keyskills :
    GMP ISO Regulaty Affairs MDR compliance medical devices ISO 14971 document control MDD regulations class 3 USA regulations document regulations FDA

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