Quality & Regulatory Affairs EMEA at Henry Schein

Langen, Hesse, Germany -

Full Time

Start Date

Immediate

Expiry Date

17 Jul, 26

Salary

0.0

Posted On

18 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Regulatory Affairs, Project Management, ISO 13485, MDR, IVDR, GDP, Risk Management, FMEA, Validation, Stakeholder Management, Compliance, CAPA, Communication

Industry

Medical Equipment Manufacturing

Description

Join Team Schein in a meaningful EMEA Quality & Regulatory Affairs role where collaboration, integrity, and continuous improvement come together. You’ll partner across countries and functions to ensure compliance, support product readiness, and help deliver trusted healthcare solutions that make a real difference. Your responsibilities will include: Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System. To provide comprehensive managerial and strategic ensuring efficient daily operations, effective communication, and seamless regional management of quality-related projects, compliance, and reporting. Supports to perform quality & regulatory visits and /or audits to countries and issues gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions. Participates to EMEA QA/RA Management meetings, issues minutes and follows-up on decided actions with related functional / country QA/RA Lead. Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up of identified actions. Driving & supporting multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives. Provides support to the PRRC of the EC Rep in Germany for Henry Schein Products by Review Quality Agreements to ensure responsibilities of economic operators (Importer/Distributor) are clearly addressed. Provides support to the Spanish QA/RA Team for Quality related topics to ensure compliance according GDP and MDR. Your Qualification Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, or a related field with previous experience in Quality Management, Project Management, Medical Device and Pharmaceutical (GDP) experience is a plus Support Communicating with Regulatory Bodies MDR /IVDR Regulations/ ISO 13485 Validation of (computerized systems) and Risk management (FMEA) knowledge is a plus Experience in Quality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR. You are solution oriented, have problem-solving attitude, and can be pragmatic, high adaptability and flexibility Ability to work in a matrix, regional environment with different departments and countries Fleuncy in English language and a good communication skills and stakeholder management Over 90 years ago Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York, nearly 30 miles from Melville, New York, where our corporate headquarters resides today. In the depths of the Great Depression, Henry and his wife Esther made a bold bet on their future all while living their values of helping health happen and caring for their team and the community they served. Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932. Henry Schein is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners. Since our founding we have stayed true to Henry and Esther’s values which has allowed us to evolve, expand, and grow our Company. Now serving more than 1 million customers in 33 countries and territories, 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. We invite you to join approximately 25,000 Team Schein Members, who are critical to our success and are at the core of our Team Schein Values as our founders would have wanted. We live those values by ensuring that our culture focuses on the wellness of our team, which we accomplish by providing a safe space for individuals to develop and contribute authentically, with opportunities to give back to society and the communities where we live and work. No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier place. Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants. If you are unable or limited in your ability to complete the application process, including the use or access of www.henryschein.com/careers, as a result of a physical or mental impairment, you can request reasonable accommodations. Please e-mail the appropriate email address below with the type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request. US Candidates: jobsupport@henryschein.com UK and Ireland Candidates: UKHSHRRecruitment@henryschein.co.uk Australia and New Zealand Candidates: APACCareers@henryscheinone.com Malaysia Candidates: CNHR@henryschein.com Italy Candidates: risorse.umane@henryschein.it It is important to us to offer different types of work arrangements. Please see the types we offer below: Work From Home: Work is performed directly from the TSM's home office. Hybrid: Time is scheduled between working from a TSM home office and at a company facility, as required. Onsite: Work is performed exclusively at a company facility. Field: Position requires traveling to different locations within a specific geographic territory, as assigned.

Responsibilities

The role involves supporting EMEA-wide QA/RA operations, implementing quality management systems, and ensuring compliance with medical device and pharmaceutical regulations. You will also manage regional projects, conduct audits, and provide support to local teams regarding quality and regulatory requirements.