Johnson & Johnson seeks a Director of Regulatory Affairs for EMEA and Canada, leading strategy and compliance for Electrophysiology and Neurovascular products.
This position acts as the primary regulatory authority for the EMEA and Canadian territories within Johnson & Johnson MedTech. The role is dedicated to supporting the Electrophysiology and Neurovascular business units by managing all regulatory activities, ensuring market access, and aligning regional strategies with global corporate goals.
Responsibilities
- Direct and mentor regional Regulatory Affairs teams across EMEA and Canada to facilitate business expansion and speed up product launch timelines.
- Act as the regional voice in global leadership forums to influence governance structures and define strategic priorities.
- Develop comprehensive regulatory strategies that account for local country regulations, regional nuances, and cultural contexts.
- Maintain product compliance by tracking regulatory updates and implementing necessary regional adjustments.
- Build a high-performing, diverse regulatory workforce through targeted hiring, retention, and professional development initiatives.
- Represent the business and J&J MedTech interests in external regulatory meetings, trade associations, and industry forums.
- Enhance the regulatory operating model by implementing scalable processes, digital tools, and transparent data reporting.
- Manage the regional regulatory budget, ensuring all activities are completed on schedule and within financial constraints.
Requirements
- Hold a Bachelor’s degree.
- Possess at least 15 years of experience working in a highly regulated industry.
- Have a minimum of 3 years in management roles, including direct people management.
- Demonstrate senior leadership capabilities, particularly in influencing strategy and engaging with executive stakeholders.
- Show a proven history of creating regional regulatory strategies that support business objectives.
- Exhibit strong written and spoken English proficiency.
- Have prior hands-on experience with Cardiovascular submissions and a track record of securing approvals in multiple regions.
Nice to have
- Advanced degrees in medicine, engineering, science, or law.
- An MBA or other advanced graduate degree.
- Experience within the Medical Device sector.
- Global franchise or business unit regulatory experience supporting Out-of-US (OUS) markets with diverse exposure.
- Experience leading diverse teams in matrix organizations with strong cultural awareness.
- Background in managing large budget cost centers and complex financial business planning.
- Regional or multi-market Regulatory Affairs experience, including Emerging markets.
- Leadership experience collaborating with external industry groups and international organizations.
- Proficiency in additional languages spoken in the EMEA region.
What the company offers
- An inclusive workplace culture that values each individual.
- A respectful environment that honors employee diversity, dignity, and merit.
About the company
Johnson & Johnson operates under a strong commitment to its Credo, believing that health is paramount. The company strives to create a world where complex diseases are prevented, treated, and cured. It fosters a trusting, collaborative, and ethical work environment, taking responsibility for its employees worldwide.
- Guided by a core Credo that prioritizes health and ethical responsibility.
- Committed to preventing, treating, and curing complex diseases.
- Fosters a trusting and collaborative work environment.
- Values diversity, dignity, and individual merit.
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