Director, Major Markets Europe & Canada

Job title: Director, Major Markets Europe & Canada

Function: Regulatory Affairs Group

Sub function: Regulatory Affairs

Category: Director, Regulatory Affairs (PL9)

Location: Wien, Austria / Umkirch, Germany

Additional hybrid locations may be considered: Zuchwil, Switzerland / Diegem, Belgium / Leeds, UK / Loughbeg, Ireland

Date posted: May 22 2026

Requisition number: R-077663

Work pattern: Hybrid Work

Description

At Johnson & Johnson, we believe 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 uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As 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 considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: People Leader

All Job Posting Locations: Umkirch, Germany, Vienna, Austria

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, Vienna, Austria, Diegem, Belgium, Leeds, UK, or Loughbeg, Ireland.

This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Applications will be considered as a single submission.

Johnson & Johnson announced plans to separate its Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes.

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.
• Ensure 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.
• 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.
• Experience supporting global regulatory operating models preferred.
• Experience working in a global, matrixed organization preferred.
• Exposure to regulatory inspections, audits, and authority negotiations preferred.
• Demonstrated success driving regulatory transformation or process improvement initiatives preferred.
• Background in medical devices, healthcare, or other highly regulated industries preferred.
• English required; additional European languages preferred.
• Up to 25% travel across Europe.
• RAC or equivalent certification preferred but not required.

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

The anticipated base pay range for this position is: €117,600.00 - €202,860.00

Benefits

In addition to base pay, Johnson & Johnson offers benefits including an annual bonus with set target depending on pay grade and 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, service anniversary and recognition awards, and participation in insurance plans depending on location and plan terms. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.