Senior Specialist Quality & Regulatory Affairs EMEA

Henry Schein; España; Remote; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Henry Schein is seeking a Senior QA/RA professional to support EMEA-wide quality and regulatory operations, document EMEA policies, and manage CAPA follow-up, reporting to the Snr. Director QA/RA EMEA. The role is remote, based in Spain or Germany, with up to 30% travel.

Key duties include audits, change control oversight, eQMS maintenance, GDP/MDR compliance, and cross-country collaboration with QA/RA leads across the EMEA region.

Qualifikationen

• Experience in Quality Management and Project Management within Medical Devices.
• GDP experience is a plus.
• MDR/IVDR regulations and ISO 13485 knowledge required/advantageous.
• Validation of computerized systems and risk management (FMEA) knowledge is a plus.

Aufgaben

• Support EMEA QA/RA operations and document EMEA policies.
• Coordinate quality/regulatory visits, CAPA follow-up, and gap analyses.
• Organize regional meetings and ensure timely follow-ups with country QA/RA leads.
• Assist the Exec. Director QA/RA EMEA and the EMEA QA/RA team.
• Oversee eQMS maintenance and document management.
• Ensure compliance with GDP and MDR across countries.

Kenntnisse

Quality Management

Project Management

Regulatory Affairs

MDR/IVDR

GDP Knowledge

Risk Management

Validation of Computerized Systems

eQMS & Document Control

Ausbildung

Bachelor's degree in Life Sciences / Pharmacist / Biomedical Engineering / Business Management

Tools

eQMS

Jobbeschreibung

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.

This is a remote position. Applicants must be based in Spain or Germany and have the right to work in their country of residence.

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:

• 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
• 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.