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

Senior Regulatory Affairs Officer in the IVD field

Entreprise
Kelly Services
Lieu
Vaud
Date de publication
16.11.2017
Référence
383651

Description

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
 
 

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