142 - Scientific Affairs Associate for Medical Devices
3 weeks ago
Europe, UK
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Permanent contract
To strengthen our self-care medical device division, RNI – a PLG company, is seeking a Scientific Affairs Associate for Medical Devices with experience in evaluating the efficacy and safety of health products in the European market.
In this role, you’ll 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, with potential opportunities involving other nutritional and beauty products.
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. These devices aid in addressing conditions such as skin conditions, cold and allergy symptoms, pain relief, and other minor ailments. Examples include plasters, nasal sprays, eye drops, dermal creams, and more.
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 (e.g., PubMed, Cochrane, Science Direct, Medline, Cosmed).
- 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 (e.g., clinical trial planning, endpoint development, toxicological testing, additional literature searches).
- Contribute to the writing of scientific, clinical, and biocompatibility reports compliant with medical device guidelines (e.g., MEDDEV 2.7/1, MDCG, ISO standards).
- 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).
- 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.
- 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.
- Desired qualities: autonomy, flexibility, communication, technical writing, team mindset.
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