/ L'annuaire des offres d'emploi en Suisse Romande

Senior Regulatory Affairs Officer in the IVD field

Kelly Services
Date de publication


Kelly Scientific is looking for a Senior Regulatory Affairs Officer for our IVD partner localised in the Western part of Switzerland 
Job description
  • Actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation.
  • Review analytical data from development studies, performance evaluation studies, and clinical field trials to ensure regulatory requirements are met.
  • Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information.
  • Compile product information for the preparation of technical files and regulatory dossiers to support product licence applications worldwide.
  • Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities.
  • Assist with the implementation of the Company’s Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), ISO13485 standards, the 98/79/EC IVD Directive, FDA Regulations, Health Canada Medical Device Regulation, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.
Qualification & Experience required
  • Master degree or equivalent diploma in science (Master Degree in Biology, Biochemistry, Immunology, Virology or related field)
  • A minimum of 5 years of experience in regulatory within the IVD Industry, prior experience in Infectious Diseases Screening Assay a must
  • Previous experience in bringing an new product to market, significant experience of Design Control
  • Previous experience filing: BLA, PMA, 510(k), high class CE marking submission
  • Significant specialist knowledge of regulation as it applies to medical devices, IVDs, Drugs or Biologics as well as related Industry standards
  • Ability to interface with regulatory authority and analyse technical information in a structure many to be able to prepare coherent regulatory files
  • Ability to work in a multicultural team environment
  • Fluent in English
  • This role will require International Travels less than 20%
Your contact at Kelly Scientific:
Mathilde DROMARD
PhD in Biology and Health
Consultant Professional Staffing Life Science and Deputy Manager