Job Detail

Clinical Compliance Manager in Regulatory Affairs

Inseriert am: 28.09.2020

Our pioneering spirit has
along tradition.
Joachim Gebauer
Exciting challenges await on the path to realizing our vision. We are therefore seeking


Clinical Compliance Manager in Regulatory Affairs


Root
Your tasks Your qualifications



  • C ompliance review and release of Clinical Evaluation > Five years professional experience within medical device
    Reports (CER) & Post Market Clinical Follow-up (PMCF) industry
    reports

  • Masters degree or PhD in natural sciences or medical

  • Advice and plan for product specific CERs, PMCF plans/ doctor
    reports and marketing claim strategies, internally aligned > Relevant experience in CER writing and/or conducting
    with Marketing, Clinical Affairs and stakeholders
    clinical studies

  • Creation of Safety & Clinical Performance Summaries > Familiar with pertinent regulations and guidance
    (SSCP)
    documents, such as MDR, MEDDEV 2.7.1, MEDDEV 2.12.2,

  • Communicate and negotiate with Notified Bodies on the and ISO14155, and MDCG guidances
    above subjects

  • Fluent in English and German is an asset

  • Conduct and expand clinical intelligence activities

  • Maintain/evolve process for clinical documentation


Geistlich Pharma is a family-run Swiss company and a longstanding global leader in regenerative dentistry. We have a long tradi-
tion of pioneering attitudes that place the focus on employees. These employees are dedicated to the spirit that drives our company
to excel: a passion for regeneration. This is the origin of our innovative medical products that reconstruct bones, cartilage and soft
tissue. Our motivated team looks forward to working with you in a modern, dynamic environment with international flair.
We look forward to receiving your completed electronic application at: recruiting@geistlich.ch
If you have any questions about the position, please contact: Marco Steiner, Deputy Director & Group Lead Regulatory Affairs,



  • 41 41 492 55 55


www.geistlich-pharma.com

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