Senior Specialist Quality & Regulatory Affairs EMEA

Henry Schein

Contract type

Ongoing

Work mode

Remote · EMEA

Experience

Senior · Not stated

Level inferred from job title

Job description

Supports EMEA-wide QA/RA operations for Henry Schein, including documenting EMEA policies, supporting implementation of the EMEA Quality Management System, performing quality and regulatory visits/audits, and CAPA follow-up. The role is home based in any EMEA country with regular travel up to 30%.

At a glance

Work mode: Remote · EMEA
Languages: English – fluent

What you'll do

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, inspection readiness initiatives and roll-out of required tools, conduct and oversee quality training and compliance communications
Assists PRRC and EC Rep responsibilities such as adverse event reporting, post-market surveillance and FSN management
Other tasks and projects as needed

What we're looking for

Quality Management, Project Management experiences, Medical Device Experiences
MDR /IVDR Regulations/ ISO 13485
Bachelor's degree in Life Sciences, Pharmacist, Biomedical Engineering, Business management or a related field
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
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
Job holder based in any country in EMEA
Home based – ready to travel regularly (up to 30%)

Nice to have

Pharmaceutical (GDP) experience is a plus
Validation of (computerized systems) and Risk management (FMEA) knowledge is a plus

Your team

EMEA QA/RA

EMEA QA/RA Team supporting EMEA-wide QA/RA operations within the Global Distribution Group

Save

About Henry Schein

Key facts

Sites in EMEA