specialist 3, regulatory affairs à Zuchwil

publié
contact
Audrey Bisch, Bâle Professionals Health Care & Life Sciences
type d'emploi
contract
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job details

publié
lieu
zuchwil, soleure
secteur
life sciences
type d'emploi
contract
référence
17585
contact
audrey bisch, bâle professionals health care & life sciences
téléphone
058 201 55 50

description du poste

Do you want to work in a big medical devices company? Do you have experience in Regulatory Affairs for Medical Devices? You should then read the following lines!

 

Our client, based in the Solothurn area, is looking for a  Senior Regulatory Affairs Specialist for a contract until the end of the year with possibility of extension.

 

Your Responsibilities: 

  • Support local franchise Regulatory team for various activities in conjunction with base business support.
  • Support preparation of design dossier documentation and technical documentation for submission to and review by Notified Bodies, as assigned.
  • Provide regulatory support for New Project Development projects as assigned with focus on CE marking and US requirements (510(k))
  • Provide regulatory support for Life Cycle Management project as assigned
  • Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
  • Perform Regulatory Change assessments as assigned,
  • Perform Labeling and Promotional Material Reviews as assigned.
 

Your Profile:

  • At least 4 years of experience in Medical Device Industry and Regulatory Affairs.
  • Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)
  • Understanding of requirements of current Council Directive 93/42/EEC
  • Experience with creation and maintenance of Class III Design Dossiers and Technical Documentation in PLM Systems preferred
  • Experience in IT system documentation and database management preferred
  • Experienced skills in MS Office (Excel, Access) for data analyses and comparisons
  • Ability to comprehend principles of engineering, physiology and medical device use.
  • Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.

NB: the position foresees presence at site (3 days physical presence in the office, 2 days home office)

 

Do not waste any minutes, apply now!  We are looking forward to receiving your application.

Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.