Quality and Compliance Manager

  • Closing date 14 Jul 2019
  • Type Full-time
  • Duration Permanent

Cambridge Heartwear is medical device and algorithm company using artificial intelligence and computer science to transform management of cardiovascular health.

 

We’re looking for an experienced Quality and Compliance Manager, who is enthusiastic about innovation and unfazed by the regulatory challenges involved in bringing medical devices to market. The ideal candidate will have previously managed activities required to obtain CE marking for medical devices (hardware and software) in line with the Medical Devices Regulation (EU) 2017/745. The role is undoubtedly challenging, so we need someone who will be able to cope well under pressure and has an all round positive outlook.

 

Essential criteria:

  • BSc or MSc (or equivalent) in science, engineering or related field or equivalent experience
  • Excellent knowledge of Medical Device Regulation (MDR (EU) 2017/745) and relevant standards
  • Able to work independently and lead our efforts to achieve regulatory compliance
  • Established and maintained an ISO 13485:2016 compliant QMS
  • Managed development and update of Technical File documentation
  • Process improvement and procedure writing expertise
  • Confident and effective communicator, able to liaise with individual team members and external stakeholders as required
  • Experience of conducting audits
  • Passionate about innovation and bringing novel medical devices to market

Desirable:

  • Previous experience working with medical device startups and able to adapt quickly in a fast paced environment
  • Previous experience working with wearable devices
  • Previous experience of obtaining FDA approval for medical devices

Benefits:

  • Salary commensurate with experience
  • Performance related bonus
  • Company pension contribution

Contact us

Thank you for your enquiry!
We'll be in touch soon.

We couldn't send your message.
Please review the fields then try again