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 for a
Medical Device Safety Specialist MDR 100% m / f (temporary until December 31, 2021)
Your main responsibilities :
Create and update technical reviews, specifications and other documents for MDR related submission
Interpret technical drawings
Interpret biocompatibility data
Review and validate reusable device cleaning and sterilization
Perform toxicological and / or microbiological assessment of manufacturing materials
Review of Safety Data Sheets (SDS) and other information on manufacturing materials
Close communication with manufacturing materials suppliers
Coordinate of analytical testing
Assist in writing risk / benefit analyses
Close collaboration with cross-functional departments Research, Quality, Supplier Quality, Regulatory, and Manufacturing
Assist in writing benefit / risk analyses
Review and preparing procedures and documents required for MDR conformity
Your Qualifications and Experience :
Minimum educational requirement is a BSc degree in relevant scientific disciplines, such as microbiology, chemistry, toxicology or biology (preferred is an MSc degree).
An advanced degree or experience in the field of medical device safety (e.g. biocompatibility or industrial sterilization) is a plus.
Completing projects with challenging time lines
Understanding of the principles and requirements of current Good Manufacturing Practice (cGMP) an advantage
Basic knowledge of industry standards and regulations, especially MDR
Fluent in German and English (written and spoken); working knowledge of French is an advantage
Basic knowledge of industry standards and regulations especially MDR.
Demonstrates strong written and verbal communication skills
Likes to work meticulously on written documents
Demonstrates an ability to utilize resources efficiently
Travel Requirements :
This dynamic Job position has a willingness to travel up to 5% worldwide.
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 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.
For this position, we accept direct applications only.
Frau Isabell Singer
Human Resources Senior Generalist