Job Detail

Regulatory Affairs Specialist (w/m) TEMP

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Requisition Number

EMEA05366

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 (from January 2019 for 12 months) for a

Regulatory Affairs Specialist (w/m) TEMP

Job Summary:

In this position you are responsible for providing regulatory support to develop and market Zimmer products.
The function is responsible for developing regulatory submission strategies, registration dossiers and managing departmental projects. You will have direct impact on the business by ensuring the quality of the task, services, or information provided to project teams or internal customers.

Your main responsibilities:

• Advise New Product Development teams when developing new products to define regulatory requirements for Europe (MDD/MDR) and international markets


• Support and participate (as necessary) in the development of the information for use and package inserts, evaluation of promotional and advertising material for compliance with applicable regulations


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


• Support design examination submissions to the notified body


• File submissions to international authorities (compile required documentation) for Zimmer GmbH products and interacts directly with competent authorities or with Zimmer entities


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


• Support of external Audits (Authorities, Notified Body)


• Work with the RA team to keep all areas of Zimmer informed of regulatory requirements and emerging issues which may affect the registration approval of products


• Identify future potential roadblocks and keeps management informed of solution options


• Prepare the technical documentation for the conformity assessment of the products


• Support Renewal of Zimmer products Internationally

Your Qualifications and Experience:

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


• 3 - 5 years Regulatory Affairs experience in medical device industry (without BSc title)


• No Regulatory Affairs experience in medical devices industry required with BSc title or equivalent


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


• Ability to independently handle regulatory assignments of any complexity as well as to identify and assess business risks for a given regulatory strategy


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


• Strong written and verbal communication skills including presentation skills


• Strong oral and written communication skills in English and basic knowledge in German


• Good computer skills, including Microsoft Office Suite

Travel Requirements:

This job position requires to travel approximately 10% of the working time.

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 online.

 

Zimmer GmbH

Jan Lucarelli
Recruiting Coordinator
Tel: +41 52 233 53 58                                                                                                          www.zimmerbiomet.com

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