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Date Added: Thu 17/03/2022

Regulatory Expert For Medical Device Submissions UK

Homebased, UK
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Company: UPSILON GLOBAL

Job Type: Permanent, FullTime

Freelance Regulatory Consultant for Aesthetic Dermatology Medical Device Submissions Package – UK

Upsilon Global are seeking a freelance Regulatory Consultant to lead on an exciting medical device submissions program across the UK for an Aesthetic Dermatology portfolio. Our partner, an exciting French pharmaceutical, are launching three studies with Class III devices to explore the anti-aging effects of their aesthetic products.

The successful candidate must have comprehensive, hands-on experience in the full regulatory lifecycle for medical devices programs and be willing to conduct all activities from essential document collection to final submission/amendments.

Main responsibilities:

  • Co-ordinate clinical trial applications from start to finish for medical device products, working in collaboration with cross-functional teams.
  • Budget and contracts’ negotiation may be required: draft or review site clinical trial agreements to ensure timely clinical trial start and compliance to the applicable local legislation.
  • Provide support for activities with outside vendors and business partners, as required (such as service agreements and work orders review).
  • Ensure that regulatory documentation and contracts are compliant to legal, regulatory regulations and company SOPs.
  • Facilitate proper filing of relevant documentation.
  • Ensure proper tracking of start-up activities in Company’s n project management tools.
  • Perform local clinical trial applications in Greece to ensure successful outcome.
  • Track changes/amendments to legislative acts pertaining to clinical trials in participating countries and timely notification of all parties involved; liaise with other local teams to collate the relevant regulatory framework.
  • Assist in relevant SOPs and guidelines’ writing, maintenance.

Job Requirements Qualifications:

  • 2 - 4 years’ experience in managing regulatory aspects of clinical trials; good knowledge of relevant regulatory environment.
  • University degree in Life Sciences is preferred.
  • Excellent command of English, both oral and written.
  • Excellent communication, planning and organizational skills.
  • Demonstrated ability to work effectively in a fast-paced environment.
  • Proficiency in standard MS Office applications.

For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on +44. (0). 20. 3. 87. 5. 99. 66. or email ‘applications (at) upsilonglobal . com’

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