Job Detail

Regulatory Affairs Specialist (m/f) 100%

inApply with LinkedIn ®|more

Requisition Number

EMEA05143

Employment Type

Full-time

Location

Winterthur

Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopedic 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 Affairs Specialist (m/f) 100%

 

Job Summary  

The general role of the Regulatory Affairs Senior Specialist is to assist the team with regulatory implementation of EU MDR. This position requires a good understanding of medical devices and their use as well as mastery of the regulatory framework in Europe, MDD 93/ 42/EC and MDR 2017/745. The Regulatory Affairs Senior Specialist specifically supports implementing the EU MDR globally for Zimmer Biomet according to the project plan.

Your main responsibilities:

• Applying regulations to business practices and provides regulatory input, advice and guidance as needed


• Assisting with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products, under the new EU MDR


• Write, refine, track and coordinate regulatory corporate procedures for harmonization of implementation of EU MDR


• Support in localization of procedures (from corporate procedures to local procedures)


• Respond to requests from different Zimmer Biomet manufacturers as needed


• Support Sr. Specialists on coordination of impact assessment of implementation of EU MDR in international licenses, closely with Regulatory Specialists from different regions, and supporting supply chain planning  


• Consolidate frequently asked questions in the area of Regulatory Affairs to support harmonized communication and clarifications


• Support on preparing materials for training and guidance to Regulatory Affairs professionals, supporting implementation of EU MDR


• Following Zimmer Biomet regulatory affairs policy and procedures

Your Qualifications and Experience:

• Bachelor’s degree required; concentration in life sciences, technical/engineering or related field, preferred


• A minimum of 2-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required


• A combination of education and experience may be considered


• Knowledge of EU and other regulatory bodies regulations


• Knowledge of overall medical devices business and regulatory environments


• Ability to learn and stay abreast of European MDR-related regulations pertinent to medical devices and biologics


• Strong writing, communication, and interpersonal skills


• Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels


• Ability to identify risk in Regulatory strategies


• Strong problem solving and analytical skills


• Effective negotiating skills


• Self-motivated and capable to work in a diverse, fast-paced and dynamic environment


• Basic computer skills, including Microsoft Office Suite

Travel Requirements:

Up to 10%.

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 Biomet offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your complete application.

 

Zimmer GmbH

Cenk Korkmaz

Human Resources

Tel: +41 58 854 84 68

www.zimmerbiomet.com

[Close][Email a friend](Please note: this link will open the page in a new browser window.)[Print][Apply for job](Please note: this link will open the page in a new browser window.)|more