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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Zuchwil, SwitzerlandJob Description:
DePuy Synthes is recruiting for a Director, QARA European MSM & CEE, located in Warsaw, Poland, Zuchwil, Switzerland or Benelux
Job Overview
The Director, QARA European MSM & CEE is responsible for providing senior leadership for Quality Assurance and Regulatory Affairs across European MSM and Central & Eastern Europe (CEE) markets within the International QARA organization. This role ensures consistent regulatory compliance, quality system execution, and effective market access across diverse and complex markets. The position has significant strategic impact by shaping regional QARA strategy, enabling sustainable business growth, and serving as a key partner to Commercial, Supply Chain, and Global QARA leadership.
Key Responsibilities
Provide strategic leadership for Quality Assurance and Regulatory Affairs across European MSM and CEE markets.
Ensure compliance with regional and country‑specific regulatory requirements, EU MDR, internal policies, and quality system standards.
Oversee regulatory strategy, submissions, and lifecycle management activities across the assigned markets.
Serve as the senior QARA escalation point for European MSM & CEE Local Market Support.
Partner with Commercial, Supply Chain, Quality, and Global Regulatory teams to support compliant product distribution and business initiatives.
Monitor regulatory and quality trends, assess risks, and drive mitigation strategies across the region.
Lead audit and inspection readiness, including internal audits, external audits, and health authority inspections.
Lead, coach, and develop regional QARA leaders and teams, fostering a strong quality and compliance culture.
Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.
Qualifications
Education:
Bachelor’s degree in Regulatory Affairs, Quality, Life Sciences, Engineering, or a related discipline (required).
Advanced degree in a scientific, regulatory, or business field (preferred).
Experience and Skills:
Required:
Typically 10-12 years of progressive experience in Quality Assurance, Regulatory Affairs, or related roles within a regulated industry.
Demonstrated senior leadership experience managing multi‑country or regional QARA organizations.
Strong working knowledge of EU MDR and European regulatory frameworks.
Experience supporting audits, inspections, and health authority interactions at a regional level.
Proven ability to influence senior stakeholders and operate effectively in a matrixed environment.
Preferred:
Experience in medical devices, orthopedics, or other highly regulated healthcare industries.
Experience working within International or emerging market regulatory operating models.
Familiarity with CEE market regulatory requirements and business environments.
Experience leading regulatory or quality transformations across regions.
Regulatory Affairs Certification (RAC) or equivalent.
Belgian citizenship with valid passport.
Strong strategic thinking, communication, and decision‑making skills.
Other:
Language: English required; additional European languages preferred.
Travel: Moderate regional and occasional international travel.
Certifications: Regulatory or Quality certifications preferred but not required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills:
Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Tactical Planning, Technical Credibility