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

Job Summary:

In this function you are responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process. 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
  • Assisting with the assembly, distribution, storage and tracking and retrieval of infor¬ma¬tion pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions to international authorities.
  • Responding to requests from foreign government and/or distributors as needed
  • Assisting with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
  • Providing the regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
  • Evaluating the risk of proposed regulatory strategies; may offer solutions
  • Reviewing the proposed labeling for compliance with applicable global regulations
  • Writing and managing the development of package inserts
  • Reviewing and evaluating of promotion and advertising material for compliance with applicable regulations
  • Reviewing the proposed product changes for impact on regulatory status of the product
  • Communicating with regulatory and governmental agencies with supervision
  • Interacting in a diverse environment, working with individuals in different geographies and countries

 

Your Qualifications and Experience:

  • University Degree (BSc) or equivalent in life sciences, technical (engineering) or related field. (Equivalent to Fachhochschule Abschluss)
  • A combination of education and experience may be considered
  • A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
  • A minimum of one year of experience in orthopaedic or Medical Device industry preferred
  • Working knowledge of FDA, EU, and other regulatory body regulations
  • Excellent communication and interpersonal skills, including presentation skills
  • Strong attention to detail; ability to multi-task and balance competing priorities
  • Knowledge of overall business environment, the orthopaedic industry, and the market place
  • Ability to learn and stay abreast of regulations pertinent to medical devices as well as the ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
  • Ability to identify risks in Regulatory strategies
  • Ability to independently handle regulatory assignments of medium complexity
  • Strong problem solving skills as well as effective negotiating skills
  • Good understanding of engineering drawings and orthopedic anatomy
  • Fluency in English both verbal and written is required
  • Basic German would be an asset
  • Good computer skills, including Microsoft Office Suite

 

Travel Requirements:

Max. 15%

 

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
8404Winterthur                                                                                                                                www.zimmerbiomet.com