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Medical Affairs Advisor Single Use Devices

Location: 

Le Plessis-Robinson, FR

Job Family:  Marketing
Country/Region:  France
Medical Affairs Advisor Single Use Devices 

 

 

Job summary

  • Participate in the clinical study program (Clinical development plan, post-market clinical follow-up plan) to support some medical devices either in development phase, or after their launch, in collaboration with the Head of Medical Affairs 
  • Managing clinical studies and/or observatories (from protocol redaction to results publication)
  • Participate in the clinical support and documentation process from the preliminary phase of new products development to post-marketing, in collaboration with internal teams, in compliance with international regulations

                       

 

Responsibilities

  • Managing clinical studies projects / surveys for registration or post-market in collaboration with Coloplast teams (Medical, innovation, R&D, Marketing):
    • Write, or participate in writing studies protocols or clinical observatories in collaboration with the Coloplast Medical team and/or the health care professionals to comply with clinical development plans and post-market plans
    • Project launch and follow-up, in compliance with international and local regulations, investigators selection, contracts management, participation in monitoring of studies or clinical records, inclusion updating, follow-up of adverse events when needed, compliance with deadlines and use of results for products support documents and/or publication; relationship with investigators

 

  • Participate in review/update of some clinical documents (CER = Clinical Evaluation Reports, products leaflets…) according to Coloplast procedures and to international authorities requirements (i.e. Meddev, MDR…)

 

  • Perform literature searches on medical devices, assess the relevance of the data, enhance and complete the available clinical elements using literature analysis or clinical studies under the supervision of medical manager.

 

 

  • To comply with the policies and procedures regarding Health, Safety and Environment (HSE).

 

 

Job qualifications

 

A graduate in the field of Health (Pharmacist, Biologist, Biotechnology engineer, …) with a graduation in clinical study management and a previous experience of Health industry (clinical studies, surveys management, literature review experience, medical device experience and knowledge of MDR CE marking process highly appreciated).

           

 

The candidate will be:

  • Autonomous, rigorous, organized, endowed with a strong analytical and synthesis spirit, enjoying working as a team on transversal and international projects, endowed with strong communication skills.

 

Fluency in oral and written English is required for this position.

 

Position based in Plessis-Robinson (92).

 

           

 

 

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

 

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

 

Visit us on Coloplast.com.

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