Director, Major Markets Europe & Canada in Leeds

Location: Zuchwil, Switzerland (Hybrid). Alternate hybrid locations: Umkirch (Germany), Vienna (Austria), Diegem (Belgium), Leeds (UK), Loughbeg (Ireland).

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. The role partners 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).

Required Experience and Skills:

• 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 Qualifications:

• 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.

Equity & Inclusion Statement: 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. Johnson & Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please contact us via the provided contact.