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Scientific Affairs Associate for Medical Devices
il y a 4 semaines
ProductLife Group is seeking a Scientific Affairs Associate for Medical Devices to strengthen our self-care medical device division. This role involves evaluating the efficacy and safety of health products in the European market.
As a Scientific Affairs Associate, you will work closely with Senior Consultants in a small dynamic team, overseeing the entire life cycle of self-care medical device development, from conception to European registration.
Self-care medical devices encompass a diverse range of products designed for over-the-counter personal use in managing minor health concerns or promoting well-being without the direct supervision of a healthcare professional.
Responsibilities:
- Evaluate scientific, clinical, and toxicology data to extract pivotal efficacy and safety information while assessing study quality.
- Conduct systematic and well-documented literature searches utilizing reputable databases.
- Perform risk assessments based on clinical, scientific, and toxicology data.
- Collaborate with Senior Consultants to integrate literature search and evaluation outcomes into self-care medical device development strategies.
- Provide recommendations to address data gaps, ensuring robust evidence to support medical device products.
- Contribute to the writing of scientific, clinical, and biocompatibility reports compliant with medical device guidelines.
- Contribute to writing sections of medical device technical files for the EU as per MDR 2017/745.
- Facilitate coordination between clients and European laboratories for scientific testing.
- Identify and interpret relevant regulatory guidelines, particularly MDR 2017/745 Regulations.
- Participate in client calls to present findings and address questions.
Education:
- Degree in Science, Toxicology, Pharmacy, Chemistry, Medical Sciences, Biomedical Sciences.
- Experience with European & UK medical device regulations.
- 2+ years demonstrated experience.
- 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.
