Coronado Research

Coronado Research helps biotech and pharmaceutical teams move faster from discovery to market. It delivers consultancy-led services across regulatory strategy, advanced analytics, market access, and…

coronado-research.com

Coronado Research

coronado-research.com

HQLondon, GB

Team Size23

Open Jobs4

Total Funding-

Latest FundraiseUnknown

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Senior Medical Device Consultant

On-SiteLondon, England, GB

On-Site • London, England, GB

Senior Clinical Medical Device Consultant

We are seeking a freelance Senior Clinical Medical Device Consultant who has experience conducting Regulatory strategies for clinical trial start up activities for a variety of European countries including UK & DE. They should also be experienced with authoring and reviewing clinical documentation to ensure compliance with EU/UK regulations and standards. The Senior Clinical Medical Device consultant will collaborate with client teams and review technical files.

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Bachelor's degree in a relevant discipline
10+ years of clinical trial experience for medical devices, with a proven track record of successful EU MDR study submissions and bringing devices to the EU/UK.
Strong analytical and problem-solving skills, with the ability to assess complex regulatory requirements and develop appropriate strategies.
Strong knowledge of EU/UK MDR regulations.
Proficient in authoring/reviewing clinical trial documentation for medical devices
Excellent written and verbal communication skills, with the ability to effectively communicate regulatory requirements and recommendations to cross-functional teams.
Detail-oriented with a high level of accuracy in regulatory documentation and submissions.
Ability to work independently and collaboratively, managing multiple projects and priorities simultaneously
Excellent written and verbal communication in English.