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Manager Regulatory Affairs (f/m)

Naturwissenschaften, Ingenieurwissenschaften, Andere akad. Ausbildung - Medizintechnik, Health Care - Unbefristet - Vollzeit
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Manager Regulatory Affairs (f/m)

Das Unternehmen

Henry Schein, Inc. is the world's largest provider of health care products and services to office-based dental,
animal health and medical practitioners. The Company also serves dental laboratories, government and
institutional health care clinics, and other alternate care sites. A FORTUNE 500© Company and a member of the
S&P 500© and Nasdaq 100© Indices, Henry Schein employs nearly 19,000 Team Schein Members and serves
more than one million customers.
The Company offers a comprehensive selection of products and services, including value-added solutions for
operating efficient practices and delivering high-quality care. Henry Schein operates through a centralized and
automated distribution network, with a selection of more than 110,000 branded products and Henry Schein
private-brand products in stock, as well as more than 150,000 additional products available as special-order
items. The Company also offers its customers exclusive, innovative technology solutions, including practice
management software and e-commerce solutions, as well as a broad range of financial services.
Headquartered in Melville, N.Y., Henry Schein has operations or affiliates in 33 countries. The Company's sales
reached a record $10.6 billion in 2015, and have grown at a compound annual rate of approximately 15 percent
since Henry Schein became a public company in 1995.

Ihre Aufgaben

KEY RESPONSIBILITIES:
• Preparation and compilation of regulatory documentation and dossiers for European and global
registrations of Medical Devices.
• Cooperation with Notified Bodies and Regulatory Authorities during registration and lifecycle of Medical
Device.
• Participate in audits by Agencies or a Notified Body.
• Maintenance of Medical Device registrations in compliance to new regulatory and technical requirements
as well as to technical and labeling changes.
• Responsible for Post Market Surveillance reporting.
• Ensure regulatory compliance for other product categories, e.g. Biocides, Cosmetics, Animal Feed etc.
• Monitoring of regulatory requirements issued by the authorities and evaluation of their relevance for the
registration status of our products.
• Regulatory support to the QA functions marketing departments and corporate brand department during
development and lifecycle of the products.
• Review and communicate proposed changes to the EU regulatory landscape and provide input to impact
assessment.
• Review and approval of product related labeling and marketing material as necessary.
• Quality system audits, internal (e.g. Distribution centers), Joint Venture manufacturing and Distribution
sites, and acquisition due diligence.
• Worker health and safety programs and audits complaints and investigations as necessary.

Ihr Profil

QUALIFICATIONS:
• University degree in natural sciences or similar.
• Several years experience in regulatory issues with background on Medical Devices.
• Project management skills.
• Excellent Excel & Word skills.
• Excellent English and good German skills Communication skills – both oral and written.
• Team work.

Unser Angebot

Bewerbung und Einstieg

Interested? Please apply online on our career section for the job posting # 16502 by providing your salary
expectations and your earliest possible starting date. For more information about Henry Schein and other
interesting vacancies, please visit our websites.
Beschäftigungsart: Unbefristet
Beschäftigungsort: Frankfurt area (Langen / Hessen), Germany
Kontakt
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