Senior Specialist Quality & Regulatory Affairs EMEA

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.

ESSENTIAL DUTIES AND 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

Physical Activities:

• Job holder based in any country in EMEA
• Home based – ready to travel regularly (up to 30%)

QUALIFICATIONS

Experience

• 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.

Specialised 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

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.*

• Information on pay transparency in accordance with 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 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, to ensure equal pay, we will not ask about your current or previous salary at any later stage of the process.

• This notice does not constitute a guarantee of an employment contract or of a specific salary.