Sensorion is recruiting a Regulatory Affairs Associate Medical Devices F/M.
Based on Sensorion Paris or Montpellier site and reporting to the Quality & Medical Device Strategy Manager, the Medical Device (MD) Regulatory Affairs (RA) Associate assist in implementing the appropriate strategies to allow Sensorion deploying the medical devices, and related materials, associated to its portfolio.
Within the scope of Sensorion activities with the medical devices associated to its portfolio:
- Support to quality, technical and regulatory due diligences of potential new medical device-oriented collaborations that Sensorion would consider.
- Support to the oversight of Sensorion medical device-oriented collaborations, and in the management internal and external teams involved with the medical device-oriented collaborations.
- Identification of regulatory requirements applicable to medical device-oriented-projects, establishment of associated action plans.
- Establishment and/or maintenance of procedures to ensure robustness and compliance of Sensorion regulatory requirements in the regions where the company seeks to deploy the medical devices.
- Support, where applicable, to the collection, collation and evaluation of scientific data from a range of sources;
- Support to regulatory submissions and/or interactions with regulatory authorities / notified bodies.
- Oversight management of MD-related regulatory consultants.
- Support to the design and/or selection and/or qualification and/or management and/or maintenance of regulatory documentation management tools.
- Review and/or design of product documentation.
- Support to the review and/or planning, development and implement of post-market clinical follow-up plans with the medical devices manufacturers.
- Support to the establishment of strategic plans throughout the development of a new medical device.
- Preparation and support to the management of medical device-related regulatory audits and inspections.
- Regular reviews of the company practices and proposals for changes to systems.
Information / Advice / Training
- Regulatory Intelligence, associated impact analyses and support the implementation of action plans, with regards to applicable national and international legislation, guidelines and industry practices.
- Support and/drive awareness and training of Sensorion teams on applicable regulatory requirements.
- Education: Life Sciences, Biomedical Sciences, Pharmacy, Engineering / Biotechnology, Regulatory Affairs or equivalent.
- Professional experience: 0-3 years.
- Strong knowledge of medical device regulations and quality standards (e.g., Eur. Dir. 93/42/EEC and 98/78/EC, IMRDFs, MDR 2017/745, IVDR 2017/746, ISO 13485, ISO 14971, ISO 14155, MDCGs, ISO 10993 series, IEC 62304);
- Knowledge of problem solving and project management tools;
- French: Excellent expression (written, read and spoken).
- English: Good written and oral communication.
- Strong level of involvement and very good team spirit.
- Rigor, autonomy, responsiveness, and adaptability.
- Respect for confidentiality.
Several incidents involving organizations and individuals claiming to be fraudulently recruiting on behalf of Sensorion have recently been identified.
The objective of the fraudsters is to extort money from applicants by requesting additional expenses (medical devices, travel agency, visa fees, etc.) or obtaining personal data (bank details, address, etc.). Please note that Sensorion, its subsidiaries or the recruitment firms they appoint during the hiring process do not request financial contributions or bank details from candidates under any circumstances.
We take this situation very seriously and are taking all possible actions to identify and put an end to this type of fraud.
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