Regulatory Affairs Director- G5+ Canada

The Opportunity

We are seeking an experienced Director, Regulatory Affairs – G5+ Canada to lead regional regulatory strategy and execution across the MedTech portfolio. This role is responsible for driving regulatory excellence, accelerating product approvals, maintaining market access, and influencing the evolving regulatory landscape in partnership with health authorities and industry stakeholders.

As a senior leader, you will work across multiple markets and business units, collaborating closely with commercial, quality, supply chain, and global regulatory teams to support business growth while ensuring compliance with applicable regulations.

Key Responsibilities

• Lead and execute regional regulatory strategies that support business objectives and sustainable growth across the MedTech portfolio.
• Develop a forward-looking regulatory vision aligned with global regulatory strategies, business priorities, and emerging regulatory requirements.
• Drive regulatory approvals and market expansion through effective regulatory planning and execution.
• Ensure continued market access by providing strategic regulatory guidance throughout the product lifecycle.
• Monitor and assess changes in regulatory requirements, proactively identifying business impacts and mitigation strategies.
• Represent Johnson & Johnson with regulatory authorities, trade associations, and industry groups to help shape the regulatory environment and promote harmonization.
• Partner with Quality, Supply Chain, Commercial, R&D, and other cross-functional stakeholders to support business initiatives, transformation projects, labeling updates, and product changes.
• Provide regulatory leadership for acquisitions, divestitures, and other strategic business initiatives.
• Drive process excellence, operational efficiency, and adoption of digital tools and data-driven decision-making.
• Lead budget planning and resource management for regulatory activities and projects.
• Build, develop, and retain a high-performing and diverse regulatory organization while fostering an inclusive and collaborative culture.
• Serve as an active member of both the Global Regulatory Affairs Leadership Team and the regional leadership team, influencing strategy, business planning, and decision-making.

Qualifications

Required

• Bachelor's degree in Science, Engineering, Life Sciences, Regulatory Affairs, or a related field.
• Minimum of 10 years of experience within a regulated industry.
• Proven leadership experience, including people management and leading teams within complex matrix organizations.
• Strong experience developing and executing regional or multi-country regulatory strategies.
• Demonstrated ability to influence senior leaders and drive business decisions at executive levels.
• Experience managing complex programs, budgets, and cross-functional initiatives.
• Knowledge of global regulatory frameworks and regulatory compliance requirements.
• Excellent communication, stakeholder management, and leadership skills.
• Fluent English communication skills, both written and verbal.

Preferred

• Advanced degree (MBA, Master's, PhD, MD, JD, or equivalent).
• Experience within the Medical Device industry.
• Experience supporting international and emerging markets.
• Cardiovascular regulatory submission experience with a proven record of obtaining approvals across multiple regions.
• Experience working directly with health authorities, industry associations, and regulatory advocacy initiatives.
• Additional languages such as Spanish or Portuguese are an advantage.

What You'll Bring

• Strategic thinking and business acumen.
• Strong regulatory expertise combined with a commercial mindset.
• Ability to lead through influence in a global matrix environment.
• Exceptional relationship-building and stakeholder management skills.
• Passion for developing talent and building high-performing teams.
• Commitment to Johnson & Johnson's Credo values and ethical leadership.

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