Senior Medical Device Consultant

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 in a variety of European countries, including the UK and Germany. The candidate 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.

Qualifications

• 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.