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Scientific Affairs Associate for Medical Devices

Il y a 2 mois


Courbevoie, Île-de-France ProductLife Group Temps plein
About the Role

We are seeking a highly skilled Scientific Affairs Associate for Medical Devices to join our team at ProductLife Group. As a key member of our self-care medical device division, you will play a crucial role in evaluating the efficacy and safety of health products in the European market.

Key Responsibilities
  • Evaluate Scientific Data: Assess scientific, clinical, and toxicology data to extract pivotal efficacy and safety information while evaluating study quality.
  • Conduct Literature Searches: Perform systematic and well-documented literature searches utilizing reputable databases (e.g., PubMed, Cochrane, Science Direct, Medline, Cosmed).
  • Risk Assessments: Perform risk assessments based on clinical, scientific, and toxicology data.
  • Collaborate with Senior Consultants: Work closely with Senior Consultants to integrate literature search and evaluation outcomes into self-care medical device development strategies.
  • Provide Recommendations: Offer recommendations to address data gaps, ensuring robust evidence to support medical device products (e.g., clinical trial planning, endpoint development, toxicological testing, additional literature searches).
  • Scientific Reporting: Contribute to the writing of scientific, clinical, and biocompatibility reports compliant with medical device guidelines (e.g., MEDDEV 2.7/1, MDCG, ISO standards).
  • Medical Device Technical Files: Contribute to writing sections of medical device technical files for the EU as per MDR 2017/745 (e.g., Clinical Evaluation Report, Biocompatibility, Post Marketing Clinical Follow Up, Usability, Risk Assessments, and more).
  • Client Coordination: Facilitate coordination between clients and European laboratories for scientific testing.
  • Regulatory Guidelines: Identify and interpret relevant regulatory guidelines, particularly MDR 2017/745 Regulations.
  • Client Presentations: Participate in client calls to present findings and address questions.
Requirements
  • Education: Degree in Science, Toxicology, Pharmacy, Chemistry, Medical Sciences, Biomedical Sciences.
  • Experience: 2+ years demonstrated experience in a similar role.
  • Skills: Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel. Ability to work independently with minimal supervision, and as part of a team.
  • Desired Qualities: Autonomy, flexibility, communication, technical writing, team mindset.