Job Detail

2 Regulatory Affairs Senior Specialists (m/f) 100%

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Requisition Number

EMEA05144

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 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

2 Regulatory Affairs Senior Specialists (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 an advanced 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


• Writing, refining, tracking and coordinating regulatory corporate procedures for harmonization of implementation of EU MDR


• Support sites on local gap analysis and guide implementation of EU MDR


• Coordinate impact assessment of implementation of EU MDR in international licenses, closely with Regulatory Specialists from different regions, and supporting supply chain planning  


• Evaluate risks of proposed regulatory strategies and propose solutions for implementation of EU MDR


• Review proposed product changes for impact on regulatory status during grace period of EU MDR


• Provides training and guidance to Regulatory Affairs professionals, supporting implementation of EU MDR

Your Qualifications and Experience:

• Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred


• A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field required


• A minimum of 2 years of experience in orthopedic or medical device industry preferred


• Mastery of current EU regulations and proficient knowledge of other global regulations


• Proficient knowledge of overall business environment, the orthopedic industry, and the marketplace


• Proficient knowledge of European/MDR-related regulations pertinent to medical devices and biologics


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


• Demonstrated strong writing, communication, and interpersonal skills


• Intermediate computer skills, including Microsoft Office Suite


• Ability to communicate efficiently and influence others

Travel Requirements:

Up to 20%.

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

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