Director, Major Markets Europe & Canada

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

• Bachelors 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 ; additional European languages preferred.

• Travel: Up to 25% travel across Europe.

• Certifications: RAC or equivalent preferred but not .

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 internal employees contact AskGS to be directed to your accommodation resource.

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