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Regulatory Affairs Associate IRR Acceleration Project m/w (temporary for 12 month)

Zimmer GmbH

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Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

For the European Headquarter, based in Winterthur (Switzerland), we are looking for a:

Regulatory Affairs Associate IRR Acceleration Project m/w (temporary for 12 month)

Job Summary:

This position is intended for assisting Regulatory Affairs (RA) personnel as well as for independently researching regulatory files and databases to respond to requests, from inside and outside Zimmer Biomet. The occupant will support submissions to international authorities (compile required documentation) for Zimmer Biomet products. The function has direct impact on the business by ensuring the quality of the task, services, or information provided to project teams or internal customers.

Your main responsibilities:

  • Supporting the activities for CE marking and international registrations of products and renewals of product licenses
  • Supporting of the submissions to international authorities (compile required documentation) for Zimmer Biomet products
  • Working with the Regulatory Affairs personnel to obtain Certificates of Products for Export or other applicable export notifications from Swissmedic
  • Supporting of the Renewal of Zimmer product licenses Internationally
  • Obtaining the notarizations, legalizations and other official documents
  • Utilizing of the several different computer sources for maintaining and extracting data
  • Assisting other staff as needed
  • General typing and filing of RA documents
  • Interacting in a diverse environment, working with individuals in different geographies and countries


Your Qualifications and Experience:

  • Professional education including apprenticeship (administrative or technical)/ (Equivalent to Berufslehre) or University Degree (BSc) or equivalent in life sciences, technical (engineering) or related field (Equivalent to Fachhochschule Abschluss)
  • A minimum of one year in an office environment, utilizing similar skills, preferred
  • Familiarity with medical terminology, anatomy and product knowledge, strongly preferred
  • Excellent communication skills
  • Regulatory Affairs experience in medical device industry would be an asset, but is not required
  • Experience in database applications would be an asset
  • Proficiency in Windows applications, Office Suite
  • Strong attention to detail; produces high quality work without errors; able to detect spelling, punctuation and proofreading errors
  • Ability to manage, organize and prioritize all the detailed aspects of several projects simultaneously as well as to navigate difficult situations with tact and professionalism
  • Ability to work with individuals at all levels of the organization as well as government agencies, healthcare personnel and sales associates
  • Ability to follow instructions, take direction from multiple sources, and balance changing priorities
  • Self-motivated; ability to work with minimal supervision
  • Fluency in English both verbal and written is required
  • Basic German would be an asset


Travel Requirements:

Max. 5%

 

If you seize this opportunity, you will be able to develop your international experience and be a part of a great and truly global team.Zimmer Biomet offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your complete application through the following LINK.

 

Zimmer GmbH
Herr Philip Schott
Human Resources Manager
Sulzerallee 8
8404 Winterthur
www.zimmerbiomet.com