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Senior Regulatory Affairs Compliance Officer

Entreprise
Quotient
Lieu
Vaud (La Côte)
Date de publication
07.12.2016
Référence
244016

Description

Quotient is a well-established bio-manufacturing organisation where we develop
and manufacture high quality, high value, in vitro diagnostic,
immunohaematology (blood banking) products which are sold to hospitals and
blood banks around the world. We offer contract services to the bioscience
industry and currently manufacture products for major global players in the Life
Sciences sectors. Development and manufacturing capabilities include pilot and
large-scale mammalian cell culture, polyclonal antibody formulation, liquid fill,
and packaging. The company is poised for significant growth in this specialized
field of medicine through the development and commercialisation of the next generation automated platform for
transfusion diagnostics, MosaiQ™. With our facilities growing in Switzerland, Edinburgh and the US, now is an
exciting time to join the company as we advance our product portfolio!

Senior Regulatory Affairs Compliance Officer
Quotient is recruiting for an Experienced Regulatory Affairs professional to join our Regulatory Affairs team in
Switzerland.






Be the main point of contact for regulatory compliance issues
Establish, implement and maintain the post-market surveillance process
Lead and coordinate the vigilance process in interface with the complaint handling process
Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN,
recalls, MDRs (medical device reporting), BPDR (Biological Products Deviation Reports)
 Evaluate changes for compliance to regulatory requirements and ensure changes are communicated in a
timely basis as appropriate to the Regulatory Authorities (change control)
 Evaluate Product/Processes Non-Conformances, determine their impact on regulatory submissions,
determine whether their need to be reported to the Competent Authorities
 Establish, implement and maintain regulatory processes, such as industry regulatory and standards watch
and their implementation within the Quality Management System

 Master degree or equivalent in life sciences and 5 years of experience in a regulatory affairs role
 Experience in medical device / IVD / biotech industry
 Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical
devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, BLA, CMDR, etc..).
 Great attention to detail with a thorough and methodical approach to work.
 Strong verbal and written communications with ability to effectively communicate at multiple levels in
the organization
 Manage Site registration process for US, EU and other jurisdictions as appropriate.



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