As the largest provider of health care products and services to office-based dental and medical practitioners, Henry Schein Inc. understands what it takes to be successful. Ranked first in its industry on the FORTUNE® World's Most Admired Companies list we set ourselves apart through our culture. Our Culture is defined by our values, including mutual responsibility, ethical behaviour, creativity and open communication. More than 25,000 Team Schein Members (TSMs) worldwide help us to keep our culture and continue to thrive as a leader in our industry.
These tasks make you happy :
• Support stakeholder needs to register products at different markets by performing an assessment of national regulatory requirements
• Work closely with different business stakeholder, quality and CB Regulatory functions to make sure required documentation is available for product supply at different markets at EMEA Region
• Coordinate required labeling and packaging documentation getting in contact with... supplier and internal stakeholders
• Prepare country-specific documentation, including export related documentation for product registration in/outside Europe
• Research the legal requirements for medical devices, cosmetics, hazardous substances and biocides to identify the necessary documentation and to support the customer verification process at different markets
• Participate in projects for new business and for the regulatory compliance of existing products. Perform Regulatory compliance checks on existing product portfolio at different Markets and ensures corrective actions are implemented if needed
• Work closely with QA/RA functions at country level to support product supply and required documentation/translation is available to support product supply at different markets at EMEA Region
• Communicate with Notified Bodies and country-specific health authorities. Support communication with supplier to make sure the packaging and labelling and registration of products is compliant with national market requirements of the related country
• Monitor announcements of changes to legal requirements to support the Regulatory Intelligence process. If necessary, preparation of a gap list and/or action plan
• Support to internal and external audits and Quality Team if needed
Dein Profil und Qualifikationen:
• A background in scientific, medical, technical related field preferred Natural or Life Sciences / Pharmacist or PTA. 1-2 years Regulatory experience in Medical Device and/or Pharmaceutical Industry
• Support regulatory compliance, product registration and assessment of required documentation
• Support Communication with supplier, corporate quality /regulatory assurance and with internal stakeholder
• Knowledge and understanding of Medical Devices Regulation, Cosmetics Regulation, REACH, Dangerous Goods
• Good understanding of registration of products and coordination of required documentation
• Regulatory compliance assessment of existing Portfolio ISO 13485:2016 and knowledge of Pharmaceuticals would be a plus
• Sense of Quality Management, Audit Support, Quality System processes and contribute to meet ISO 13485 requirements.
• Ability to extract and analyze data to use as a key input for driving improvements and increase product compliance/ business compliance.
• Ability to work with different departments and countries.
• Problem solving skills, adaptability and flexibility
• Must be fluent in written and spoken Emglish
About Henry Schein, Inc.
Henry Schein, Inc. (Nasdaq: HSIC) is a solutions company for health care professionals powered by a network of people and technology. With more than 24,000 Team Schein Members worldwide, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes. The Company´s Business, Clinical, Technology, and Supply Chain solutions help office-based dental and medical practitioners work more efficiently so they can provide quality care more effectively. These solutions also support dental laboratories, government and institutional health care clinics, as well as other alternate care sites.
Henry Schein operates through a centralized and automated distribution network, with a selection of more than 300,000 branded products and Henry Schein corporate brand products in our distribution centers. A FORTUNE 500 Company and a member of the S&P 500® index, Henry Schein is headquartered in Melville, N.Y., and has operations or affiliates in 33 countries and territories.
The Company's sales reached $12.6 billion in 2022, and have grown at a compound annual rate of approximately 12.1 percent since Henry Schein became a public company in 1995.
For more information, visit Henry Schein at www.henryschein.com, Facebook.com/HenrySchein, Instagram.com/HenrySchein, and Twitter.com/HenrySchein
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