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 Headquarters, based in Winterthur (Switzerland), we are looking asap for a
Your main duties and responsibilities:
Coordinating, controlling, and supporting any activities relating to Instructions for Use (IFUs), including implementation of changes, release of IFUs and supporting process changes and technical implementation of IFUs (e.g. warehouse control, translation and printing process).
Support design and participate in the development of new IFUs in compliance with applicable regulations also of internal and external audits and inspections (Competent Authority, Notified Body).
Create, maintain and control Winterthur processes for creating, maintaining, and changing IFUs and leading of projects and subprojects pertaining IFUs.
Support of submissions to international authorities with regards to international regulations for IFUs (e.g. for product renewal) and Identify potential roadblocks, provide proposed solution and escalate to supervisor.
Leading and supporting of CAPAs pertaining IFUs and tracking of external standards and regulations applicable for IFUs.
Your Qualifications and Experience:
University Degree (BSc) or equivalent in life sciences, technical (engineering) or related field.
3 - 5 years Labeling/Regulatory Affairs/QA experience in medical device industry would be advantageous.
Ability to independently handle complex tasks in complex matrices of responsibilities, 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.
Resolve problems by identifying and applying solutions from acquired experience and the ability to defend the own position and convince other people about regulatory requirements and priorities.
Strong oral and written communication skills in English and German, including presentation skills.
Sound and comprehensive communication and diplomacy skills are required in order to achieve internal and external customer satisfaction.
Skilled in the use of the common MS Office applications (Microsoft Office Suite).
This dynamic Job position includes travel activities up to 5%.
If you seize this opportunity, you will 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.
Jan Lucarelli Recruiting Coordinator Tel: +41 52 233 53 58