Ph3Overview /h3 pAll Job Posting Locations: Amersfoort, Utrecht, Netherlands; Diegem, Flemish Brabant, Belgium; Oberdorf, Basel-Country, Switzerland; Warsaw, Masovian, Poland; Zuchwil, Switzerland. /p pJohnson Johnson believes health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are positioned to innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at jnj.com. /p pAs guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is treated as an individual. We respect the diversity and dignity of our employees and recognize their merit. /p h3Job Function /h3 pRegulatory Affairs Group /p h3Job Sub Function /h3 pRegulatory Affairs /p h3Job Category /h3 pProfessional /p h3Job Description /h3 pDePuy Synthes is recruiting for a Director, QARA European MSM CEE. This hybrid position will be based in Warsaw, Poland. Alternate hybrid locations may be considered in Amersfoort or Utrecht (Netherlands), Diegem (Belgium), Oberdorf or Zuchwil (Switzerland). /p pPlease note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific countries that align with your preferred locations: /p ul liPoland / Belgium / Netherlands – Requisition Number: /li liSwitzerland – Requisition Number: /li /ul pRemember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. /p h3Job Overview /h3 pThe 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. /p h3Responsibilities /h3 ul liProvide strategic leadership for Quality Assurance and Regulatory Affairs across European MSM and CEE markets. /li liEnsure compliance with regional and country-specific regulatory requirements, EU MDR, internal policies, and quality system standards. /li liOversee regulatory strategy, submissions, and lifecycle management activities across the assigned markets. /li liServe as the senior QARA escalation point for European MSM CEE Local Market Support. /li liPartner with Commercial, Supply Chain, Quality, and Global Regulatory teams to support compliant product distribution and business initiatives. /li liMonitor regulatory and quality trends, assess risks, and drive mitigation strategies across the region. /li liLead audit and inspection readiness, including internal audits, external audits, and health authority inspections. /li liLead, coach, and develop regional QARA leaders and teams, fostering a strong quality and compliance culture. /li liEnsure proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth. /li /ul h3Qualifications /h3 pbEducation: /b /p ul liBachelor’s degree in Regulatory Affairs, Quality, Life Sciences, Engineering, or a related discipline (required). /li liAdvanced degree in a scientific, regulatory, or business field (preferred). /li /ul ul libExperience and Skills: /b Typically 10-12 years of progressive experience in Quality Assurance, Regulatory Affairs, or related roles within a regulated industry. /li liDemonstrated senior leadership experience managing multi-country or regional QARA organizations. /li liStrong working knowledge of EU MDR and European regulatory frameworks. /li liExperience supporting audits, inspections, and health authority interactions at a regional level. /li liProven ability to influence senior stakeholders and operate effectively in a matrixed environment. /li /ul ul libPreferred: /b Experience in medical devices, orthopedics, or other highly regulated healthcare industries. /li liExperience working within International or emerging market regulatory operating models. /li liFamiliarity with CEE market regulatory requirements and business environments. /li liExperience leading regulatory or quality transformations across regions. /li liRegulatory Affairs Certification (RAC) or equivalent. /li liBelgian citizenship with valid passport. /li liStrong strategic thinking, communication, and decision-making skills. /li /ul ul libOther: /b Language: English required; additional European languages preferred. /li liTravel: Moderate regional and occasional international travel. /li liCertifications: Regulatory or Quality certifications preferred but not required. /li /ul pJohnson 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. /p pJohnson 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 internal employees contact AskGS to be directed to your accommodation resource. /p p#DePuySynthesCareers /p h3Required Skills /h3 pbPreferred Skills: /b /p pAnalytical 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 /p pbThe Anticipated Base Pay Range For This Position Is /b /p pzł435.000,00 - zł752.100,00 /p h3Benefits /h3 pIn addition to base pay, we offer the following benefits: an annual bonus with set target (%) of pay depending on pay grade/location, vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees and eligible dependents can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being career growth | Johnson Johnson Careers. /p pThis is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change. /p /p #J-18808-Ljbffr