Job Detail

Regulatory Affairs Senior Specialist

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Requisition Number

EMEA06451

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 Headquarter, based in Winterthur (Switzerland), we are looking for a

Regulatory Affairs Senior Specialist

In this position you will be responsible for providing regulatory support to develop and market Zimmer products. This includes developing regulatory submission strategies, managing departmental projects, reviewing labeling and providing guidance and consultation for EU, US and international regulations. You’ll also be interacting with regulatory agencies, and certification bodies. We have opportunities for you to mentor and train junior team members. In this position you will have a direct impact through the provision of regulatory advice/counsel related to business and technology.

Your Main Responsibilities:

New Product Development and Custom Made Devices

• Advise New Product Development teams on regulatory strategy for Europe and international markets and prepare the technical documentation


• Support development of package inserts, evaluate promotional and advertising material for compliance with applicable regulations


• Provide guidance on standards, guidance documents and regulations


• Support MDR submissions to the notified body and author 510 (k) submissions


• Perform conformity assessment of custom made devices according to the applicable regulations

Post Market Engineering and Quality Management

• Review proposed product and process changes for impact on regulatory status of product


• Support of Post Market Surveillance activities


• Convert technical documentation to MDR and support technical documentation audits


• Implement RA relevant regulations into QMS procedures

International Registrations

• File submissions to international authorities for Zimmer GmbH products and interact directly with competent authorities or with Zimmer entities

Custom Made Devices

• Perform conformity assessment of custom made devices according to the applicable regulations

Your Qualifications and Experience:

• University Degree (BSc) or equivalent in life sciences, technical (engineering) or related field.


• 3 - 5 years Regulatory Affairs experience in medical device industry


• Strong written and verbal communication skills including presentation skills.


• Working knowledge of and experience applying EU & US medical device regulations and guidance documents


• Ability to independently handle regulatory assignments of any complexity


• Ability to lead regulatory aspects of projects as a core team member and ability to establish buy-in from other team members.


• Ability to plan work in a systematic way by identifying and organizing all activities, including those of other functional areas, into time-dependent sequencing with realistic but aggressive timelines.


• Fluency in English both verbal and written, Basic German both verbal and written

 

Travel Requirements

This dynamic job position requires a willingness to travel (up to 10%). 

 

This is a unique opportunity to develop your international experience and be a part of a 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 online. 

For this position we accept direct applications only.

 

Zimmer GmbH

Human Resources

Sulzerallee 8                            

8404 Winterthur                        

Phone +41 (0) 58.854.81.81                                                      

www.zimmerbiomet.com

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