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.
Joining the Team based at our manufacturing site in Winterthur, Switzerland we are looking for a
Temporary Regulatory Affairs Specialist (01.08.2021 – 30.11.2021)
This position is responsible for providing regulatory support to develop and market Zimmer products. The function is responsible for developing proposed regulatory submission strategies, registration dossiers and support management of departmental projects and for providing regulatory input and review of labeling. The occupant will support submissions to international authorities (compile required documentation) for Zimmer GmbH 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.
- Prepare the technical documentation for the Conformity assessment of the products
- Support and participate (as necessary) in the development of labels and instructions for use, evaluation of promotional and advertising material for compliance with applicable regulations
- Track of external standards applicable to products and processes and review proposed product and process changes for impact on regulatory status of products
- Support of submissions to international authorities (compile required documentation) for Zimmer GmbH products to obtain Certificates of Products for Export
- Support of Post Market Surveillance activities
- Support renewal of Zimmer products internationally
- Work with the RA Team to keep all areas of Zimmer informed of regulatory requirements and emerging issues which may affect the registration approval of products
Your Qualifications and Experience
- Professional education including apprenticeship (administrative or technical) or University Degree (BSc) or equivalent in life sciences, technical (engineering) or related field
- 3 - 5 years’ Regulatory Affairs experience in medical device industry if the candidate does not have BSc or equivalent
- Good understanding of engineering drawings and orthopedic anatomy
- Working knowledge of and experience applying EU & US medical device regulations and guidance documents. Background in QA or RA in medical device area and working knowledge of EU medical device regulation is preferred
- Ability to identify and assess business risks for a given regulatory strategy, lead regulatory aspects of projects as a core team member, and establish buy-in from other team members
- Ability to plan work in a systematic way by identifying and organizing all activities, including those of other functional areas, into time-dependent sequencing with realistic but aggressive timelines
- Ability to resolve problems by identifying and applying solutions from acquired experience, guided by precedents
- Sound and comprehensive communication and diplomacy skills are required in order to achieve internal and external customer satisfaction within the global Zimmer Biomet network
- Fluency in English both verbal and written, basic German both verbal and written
- Good computer skills, including proficiency with MS Office (including Excel)
This is a unique opportunity to develop your international regulatory experience and be a part of a 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 online.
Please note that for this position we accept direct applications only.
Zimmer Switzerland Manufacturing GmbH