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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
People Leader
All Job Posting Locations:
Zuchwil, Switzerland
Job Description:
DePuy Synthes is recruiting for a Director, Major Markets Europe & Canada, this hybrid position is located in Zuchwil, Switzerland. Alternate Hybrid locations may be considered at Umkirch, (Germany) or Vienna, (Austia) or Diegem, (Belgium) or Leeds, (UK) or Loughbeg, (Ireland).
Please 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 country(s) that align with your preferred location(s):
Umkirch, (Germany) or Vienna, (Austia) or Diegem, (Belgium): Requisition Number: R-077663
Leeds UK - Requisition Number: R-077656
Loughbeg, (Ireland) - Requisition Number: 078166
-** Zuchwil, Switzerland - **Requisition Number: 074454
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
**Job Overview **
The Director, Major Markets Europe & Canada, provides strategic regulatory leadership across key European markets and Canada, ensuring compliance with local and regional regulatory requirements while enabling timely and sustainable market access. This role plays a critical leadership position, partnering with commercial, quality, and global regulatory teams to manage regulatory risk, shape strategy, and support business growth in complex and highly regulated markets.
**Key Responsibilities **
Lead and oversee regulatory affairs strategy and execution for Major Markets Europe and Canada, aligned with global regulatory objectives.
Ensure compliance with EU, Canadian, and country-specific regulatory requirements, internal policies, and quality system standards.
Provide strategic regulatory guidance for product registrations, renewals, variations, and lifecycle management.
Serve as the senior regulatory leader and escalation point for Europe and Canada local market support.
Partner with cross-functional stakeholders including Commercial, Quality, Supply Chain, Legal, and Global Regulatory Affairs.
Monitor regulatory changes across Europe and Canada and assess potential impact on products, portfolios, and operations.
Support and oversee regulatory inspections, audits, and health authority interactions.
Lead, coach, and develop regional regulatory leaders and teams, fostering strong compliance, accountability, and performance.
Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.
**Qualifications **
Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).
Advanced degree or professional certification in Regulatory Affairs (preferred).
**Experience and Skills: **
Required:
Typically 10-12 years of progressive experience in Regulatory Affairs within the medical device or other regulated industries.
Strong knowledge of EU MDR, UK, and Canadian regulatory requirements and health authority processes.
Demonstrated experience leading multi-country regulatory portfolios in major markets.
Proven ability to develop and execute regulatory strategies aligned to business objectives.
Strong leadership, stakeholder management, and decision-making capabilities.
Ability to manage regulatory complexity and risk in a dynamic, global environment.
Preferred:
Experience supporting global regulatory operating models.
Experience working in a global, matrixed organization.
Exposure to regulatory inspections, audits, and authority negotiations.
Demonstrated success driving regulatory transformation or process improvement initiatives.
Background in medical devices, healthcare, or other highly regulated industries.
Other requirements:
Language: English required; additional European languages preferred.
Travel: Up to 25% travel across Europe.
Certifications: RAC or equivalent 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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#DePuySynthesCareers
**Required Skills: **
Preferred Skills:
Business Writing, Collaborating, Compliance Risk, Continuous Improvement, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking