Senior Specialist Quality & Regulatory Affairs EMEA

Role Summary

Supports EMEA-wide QA/RA operations, participating to EMEA QA/RA Management meetings, documenting EMEA policies, accompanying the Snr. Director QA/RA EMEA to perform quality visits to countries and issue gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions within the Global Distribution Group Henry Schein Sites in EMEA.

Physical Activities

Job holder based in any country in EMEA

Home based – ready to travel regularly (up to 30%)

Other

Balances a sense of urgency of time pressures with adherence to all regulatory requirements.

• Sensitive in dealing with confidential Information
• Demonstrates advanced oral and written communication skills
• Must be fluent in written and spoken English
• Information on pay transparency pursuant to Directive (EU) 2023/970

Please note that we comply with the relevant legal obligations regarding pay transparency, in particular those set forth in the EU Pay Transparency Directive (Directive (EU) 2023/970) and its respective national implementation.

In this context, we will inform you of the starting salary or the corresponding salary range for the advertised position no later than before the first job interview or before a personal discussion of your application. This information is based on objective, gender-neutral criteria established for the position in question.

Please note that we will not ask about your current or previous salary during the rest of the process in order to ensure equal pay.

This notice does not constitute a claim to the conclusion of an employment contract or to a specific salary.

We sincerely appreciate your interest in joining our team. We value each application and dedicate the necessary time to review them carefully. If you do not receive a response from us within 15 days of submitting your application, unfortunately, you have not been selected to move forward in the selection process at this time.

We encourage you to continue exploring new opportunities within our company and once again express our gratitude for considering Henry Schein as the next step in your career.

Thank you very much, and we wish you the best of luck in your professional search!

At Henry Schein Schmidt, we promote a diverse and inclusive work environment. We are committed to providing equal opportunities to all qualified applicants, regardless of their ethnic background, gender, religion, sexual orientation, disability, age, or any other characteristic protected by law.

Responsibilities

• Supports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System.
• Supports to perform quality & regulatory visits and /or audits to countries and issues gap analysis, ensures CAPA follow-up and related documentation on identified issues and support countries in implementing solutions.
• Organizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up on decided actions with related functional / country QA/RA Lead.
• Support and assistance to Exec. Director QA & RA EMEA and the EMEA QA/RA Team
• Support to multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives.
• Maintenance of eQMS and Quality Document Management Tool
• Oversight of change control activities and CAPA follow-up, timely closure
• Provides support to the country QA/RA Teams in Quality related topics to ensure compliance according GDP and MDR.
• Implementation of regulatory requirements and continuous improvement, support to ongoing transformation projects and product launch activities
• Support roll-out eQMS implementation in identified countries. o Inspection readiness initiatives and to roll- of required tools o Conduct and oversee quality training and compliance communications.
• Assits PRRC and EC Rep responsibilities such as adverse event reporting, post-market surveillance and FSN management
• Other tasks and projects as needed

Requirements

• Quality Management, Project Management experiences, Medical Device
• Experiences, Pharmaceutical (GDP) experience is a plus
• MDR /IVDR Regulations/ ISO 13485
• Validation of (computerized systems) and Risk management (FMEA) knowledge is a plus

Education

Bachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, Business management or a related field.

Specialise d Knowledge and Skills

• Knowledge and understanding of Quality Management Systems and Project Management
• Quality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR.
• Solution oriented, problem-solving attitude, pragmatic, high adaptability and flexibility
• Ability to work in a matrix, regional environment with different departments and countries
• English speaker
• Good communication skills and stakeholder management

About the Company

Person Specification

We believe the type of person best suited to this role will be:

About Henry Schein

At Henry Schein, our mission is to provide innovative, integrated health care products and services; and to be trusted advisors and consultants to our customers - enabling them to deliver the best quality patient care and enhance their practice management efficiency and profitability.

We know that our Team Schein Members (TSMs) are integral to bringing our mission to life and our success has been built on the commitment of Team Schein, a highly motivated and diverse group of professionals who are dedicated to meeting the needs of our customers. Every TSM shares a singular focus, fostering an environment that allows each of us to achieve our goals.

Henry Schein offers a diverse range of career opportunities, and we firmly believe that by fostering an environment built on ethics, open communications, mutual benefits, creativity, and recognition of the contributions of all TSMs-at all levels-we can help ensure that our best years are yet to come. As such, we are proud to be an equal opportunities employer and our integrated approach to diversity and inclusion ensures success by cultivating our Culture, recruiting, and retaining diverse Talent, supporting our Marketplace, and continuing our commitment to Society.