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
Regulatory Affairs Senior Specialist
Your main responsibilities:
Coordinate the EMEA regulatory submission process and lead the development of dossiers for registration of products in EMEA countries including authoring and/or publishing electronic submissions.
Develop regulatory strategy for new products, evaluate risk of proposed regulatory strategies and provide regulatory direction to development project teams as a core team member.
Establish Zimmer Biomet EMEA RA procedures, and review proposed product changes for impact on regulatory status of the product.
Review proposed labelling as well as evaluate promotion and advertising material for compliance with applicable EMEA regulations.
Interpret and applies EMEA regulations to business practices and provide regulatory input, advice, and guidance to the organization.
Provide training and/or 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 5 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.
Agility to identify risk in Regulatory strategies and to train entry level RA associates.
Strong attention to detail, ability to multi-task and demonstrate strong writing and communication skills.
This dynamic Job position includes travel activities up to 15%.
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