142 - Scientific Affairs Associate for Medical Devices
Il y a 4 mois
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.
Group 10 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.
Group 11 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. Desired qualities: autonomy, flexibility, communication, technical writing, team mindset.
-
Scientific Affairs Associate for Medical Devices
il y a 3 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinJoin Our Team as a Scientific Affairs Associate for Medical DevicesWe are seeking a highly skilled Scientific Affairs Associate to strengthen our self-care medical device division at ProductLife Group. As a key member of our team, you will play a crucial role in evaluating the efficacy and safety of health products in the European market.Key...
-
Scientific Affairs Specialist for Medical Devices
il y a 7 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinScientific Affairs Associate for Medical DevicesTo strengthen our self-care medical device division, ProductLife Group is seeking a Scientific Affairs Associate for Medical Devices with experience in evaluating the efficacy and safety of health products in the European market.Key ResponsibilitiesEvaluate scientific, clinical, and toxicology data to extract...
-
Scientific Affairs Specialist for Medical Devices
il y a 5 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinScientific Affairs Associate for Medical DevicesTo strengthen our self-care medical device division, ProductLife Group is seeking a Scientific Affairs Associate for Medical Devices with experience in evaluating the efficacy and safety of health products in the European market.Key ResponsibilitiesEvaluate scientific, clinical, and toxicology data to extract...
-
Scientific Affairs Associate for Medical Devices
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the RoleWe 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 ResponsibilitiesEvaluate Scientific Data: Assess...
-
Scientific Affairs Specialist
il y a 4 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinProductLife Group (PLG) is seeking a highly motivated and experienced Scientific Affairs Associate for Medical Devices to join our growing self-care medical device division. In this role, you will play a crucial part in the entire life cycle of self-care medical device development, from conception to European registration. You'll collaborate closely with...
-
Regulatory Affairs Specialist
il y a 3 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the JobWe are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our Regulatory Affairs team, you will play a crucial role in the implementation of our regulatory strategy for the development and registration of oncology projects.ResponsibilitiesProvide regulatory support for all requests...
-
Regulatory Affairs Specialist
il y a 5 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the JobWe are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our Regulatory Affairs Division, you will play a crucial role in the implementation of our regulatory strategy for the development and registration of oncology projects.ResponsibilitiesProvide regulatory support for all...
-
Regulatory Affairs Specialist
il y a 2 semaines
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the RoleWe are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our Regulatory Affairs team, you will play a critical role in the implementation of our regulatory strategy for the development and registration of our oncology project.Key ResponsibilitiesProvide regulatory support for all...
-
Regulatory Affairs Specialist
il y a 6 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinAbout the JobWe are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our Regulatory Affairs team, you will play a critical role in the implementation of our regulatory strategy for the development and registration of oncology projects.ResponsibilitiesDevelop and implement regulatory strategies for...
-
Senior Regulatory Affairs Specialist 479
Il y a 4 mois
Courbevoie, France ProductLife Group Temps pleinAbout the job In the frame of a new project, we are looking for an experienced Regulatory Affairs Specialist for the following tasks, in order to contribute to the implementation of the regulatory strategy for the development and registration of oncology project : About us Group 10 Responsibilities Regulatory referral for all...
-
Hnc Bu Regulatory Affairs Manager
Il y a 4 mois
Courbevoie, France DSM-Firmenich Temps pleinThe Regulatory Affairs Manager - Postbiotics/Lacteol/Lbiome is responsible for providing a proactive and effective regulatory Affairs and pharmacovigilance support related to the development, marketed products pre and post approval commitment, registration and marketing activities associated with advertise and promotional of the Lacteol/LBiome/LBiotix...
-
Regulatory Affairs Specialist
il y a 1 semaine
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review Coordinator M/FWe are seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our internal teams in the EU. This role will be responsible for ensuring and coordinating the Linguistic Review for the Centralized products of one of our key clients.About ProductLife...
-
Courbevoie, Île-de-France Assystem Temps pleinAssystem stands as a prominent entity in the engineering sector, boasting over 55 years of expertise within the nuclear domain. Recognized among the top three engineering firms in the nuclear industry, Assystem presents an exciting opportunity for a Lead Engineer in Scientific Calculations.Position Overview:Design and enhance scientific calculation...
-
Regulatory Affairs Specialist
il y a 6 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company, ProductLife Group. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products...
-
Regulatory Affairs Specialist
il y a 6 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Officer / Linguistic Review Coordinator M/FWe are seeking a highly skilled Regulatory Affairs Officer / Linguistic Review Coordinator to join our internal teams in the EU. The successful candidate will be responsible for ensuring and coordinating the Linguistic Review for the Centralized products of one of our key clients.About ProductLife...
-
Senior Specialist, Market Access
Il y a 3 mois
Courbevoie, France Pharmalex Temps plein**We are growing, grow with us!** Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then, PharmaLex is your career choice! PharmaLex is part of Cencora - the leading service provider for the pharmaceutical, biotech, and medical device industries globally. PharmaLex is specialised in effectively...
-
Regulatory Affairs Specialist
il y a 3 jours
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our pharmaceutical company, ProductLife Group. The successful candidate will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally.Key...
-
Medical Science Liaison Specialist
il y a 6 jours
Courbevoie, Île-de-France IQVIA Temps pleinMedical Science Liaison Role **About the Opportunity** We are seeking a highly skilled Medical Science Liaison to join our team at IQVIA. As a Medical Science Liaison, you will play a critical role in bridging the gap between cutting-edge science and clinical practice. **Key Responsibilities** * Participate in national and international congresses,...
-
Regulatory Affairs Team Lead
il y a 2 heures
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Team LeadWe are seeking a seasoned Regulatory Affairs Team Lead to join our team at ProductLife Group. As a key member of our Regulatory Affairs department, you will be responsible for leading a team of regulatory professionals and coordinating projects to ensure compliance with EU regulations.Key Responsibilities:Lead a team of regulatory...
-
Regulatory Affairs Specialist
il y a 17 heures
Courbevoie, Île-de-France ProductLife Group Temps pleinRegulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our pharmaceutical company, ProductLife Group. The successful candidate will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally.Key...