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Regulatory Affairs Specialist (m/w) in the northern part of Swi

Location Wil, Switzerland
Sector
Job Type Permanent
Salary Negotiable
Published 3 months ago
Start Date ASAP
Contact Petra Ognjenovic
Job Ref SPPO2404_1524590346

Job Description

 

Regulatory Affairs Specialist (m/w) in the northern part of Switzerland

 

Our customer collaborates with healthcare professionals around the globe to advance the pace of innovation in of medical devices. The products and solutions help treat patients suffering from disorders of, or injuries to, bones e.g.. Together with healthcare professionals, we help millions of people live better lives.

If you seize this opportunity, you will able to develop your international experience and be a part of a great and truly global team. Our client offers a wide range of challenging career advancement opportunities and a dynamic work environment.

For the European Headquarters we are looking asap for following profile:

Responsibilities:

  • Prepares submission dossiers to support EMEA registration(s), re-registrations due to internal company or external government changes and renewals for expiring registrations
  • Coordinates and reviews proposed product changes for impact on regulatory submission status of the product in EMEA
  • Interpret and applies EMEA regulations to business practices and provide regulatory input, advice, and guidance to the organization
  • Provide guidance to new entry-level associates

Your Qualifications and Experience:

  • Degree in life sciences, technical (engineering) or related field (or non-US equivalent)
  • At least 2 years of experience in regulatory field and working knowledge of and experience applying International medical device regulations and guidance documents.
  • Knowledge of EMEA regulations (including labeling regulations) and knowledge of overall business environment, the orthopaedic industry and the marketplace.
  • Excellent command of English and basic in German both verbal and written, ability to speak and write additional language would be an asset.
  • Good computer skills, including Microsoft Office Suite.
  • Ability to function well as a member of the team and build relationships between RA and other areas.
  • Strong attention to detail, ability to multi-task and demonstrate strong writing and communication skills.

Möchten Sie mehr erfahren über unseren Kunden, den großen Gestaltungsfreiraum dieser Position und Ihre Entwicklungsmöglichkeiten? Dann übersenden Sie bitte Ihren CV sowie Ihre Zeugnisse unter Angabe von zwei Referenzen an Petra Ognjenovic: p.ognjenovic@sciproglobal.de. Bitte kontaktieren Sie im Falle von Rückfragen Frau Petra Ognjenovic unter: +41 43 5089217.

SciPro Global ist auf die Vermittlung von Experten aus den Bereichen Regulatory Affairs und Quality Assurance im Rahmen der Medizintechnik mit Fokus auf die D-A-CH Region spezialisiert. Die langjährige Erfahrung unserer Consultants bietet Ihnen neben einem großen Netzwerk an Kunden auch eine ausgezeichnete Branchenkenntnis sowie Beratung für den nächsten Schritt in Ihrer Karriere. Wir stehen für Qualität und freuen uns auf eine Zusammenarbeit mit Ihnen, denn uns ist am Herzen gelegen, dass die am besten qualifizierten Mitarbeiter mit dem entsprechenden Arbeitgeber in Verbindung gebracht werden.

Sollte Ihr Profil den Anforderungen entsprechen, setzen wir uns schnellstmöglich mit Ihnen in Verbindung.

 

 

 

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