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
Regulatory Reporting Senior Engineer
The Regulatory Reporting Senior Engineer works in the Regulatory Reporting Group within Complaint Handling Department of the Quality & Regulatory Affairs organization and interacts with different groups and departments, including Regulatory Affairs, Clinical Affairs group and the departments of Research, Development and Brand/Marketing. He/she creates and sends incident reports to FDA/Competent Authorities. He/she ensures efficient and compliant processes in line with corporate processes, standards and applicable international legislation. The Regulatory Reporting Senior Engineer also ensures process improvement projects in line with corporate excellence programs and group objectives. He/she represent the Regulatory Reporting team within the company and towards Competent Authorities.
Your main tasks and responsibilities
Preform reportability assessments and run decision trees, create and send incident reports, Periodic Summary Reports and prepare similar Incidents lists for submission to FDA and/or Competent Authorities.
Prepare and answer queries from other departments concerning reportable complaints, create data for statistical analyses, management reviews, quality trendings and prepare product related data summaries.
Help to improve existing processes, forms, tools and databases.
Answer case specific or general requests from Competent Authorities and act as representative of the Regulatory Reporting team.
Support updates and changes of internal procedures and create internal guidelines and forms.
Train and guide new employees within Regulatory Reporting team and support approving regulatory reports to FDA and/or Competent Authorities (as agreed with Regulator Reporting Team Leader).
Your Qualifications and Experience
Bachelor in natural sciences (or other area) or engineering degree
Significant (3-5 years) work experience in related industry (e.g. medical devices, pharma, biotech or health management) in relevant areas of Quality Management, Regulatory Affairs or management of product compliance.
Good regulatory background knowledge in medical device industry and good problem solving and interpersonal skills preferred.
Experience in writing reports and developing metrics.
Excellent command of English and German both verbal and written
Excellent time management skills, communication and writing skills.
This dynamic Job position includes travel activities up to 5%.
If you seize this opportunity, you will be able to develop your regulatory 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.