At a Glance
- Tasks: Lead regulatory strategy for major markets in Europe and Canada, ensuring compliance and market access.
- Company: Join a global leader in healthcare with a commitment to innovation and compliance.
- Benefits: Competitive salary, travel opportunities, and a focus on professional development.
- Other info: Dynamic role with opportunities for career advancement and impactful work.
- Why this job: Shape the future of healthcare by navigating complex regulations and driving business growth.
- Qualifications: 10-12 years in Regulatory Affairs with strong leadership and strategic skills.
The predicted salary is between 80000 - 120000 £ per year.
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 shape 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).
Experience and Skills Required:
- 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 required; additional European languages preferred.
- Travel: Up to 25% travel across Europe.
- Certifications: RAC or equivalent preferred but not required.
Required 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
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
Director, Major Markets Europe & Canada employer: 6010-Biosense Webster Inc. Legal Entity
At Johnson & Johnson, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. As the Director of Major Markets Europe & Canada, you will have the opportunity to lead strategic regulatory initiatives in a highly regulated environment while benefiting from our commitment to employee growth and development. With a focus on inclusivity and support for diverse backgrounds, we ensure that our employees thrive both personally and professionally in their roles across Europe and Canada.
Contact Details:
6010-Biosense Webster Inc. Legal Entity Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Director, Major Markets Europe & Canada
✨Tip Number 1
Network like a pro! Reach out to connections in the industry, attend relevant events, and engage on platforms like LinkedIn. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory landscape. Understand their products and recent news. We want you to walk in confident, ready to discuss how your experience aligns with their needs.
✨Tip Number 3
Showcase your leadership skills during interviews. Be ready to share examples of how you've led teams or projects in regulatory affairs. We believe that demonstrating your ability to manage complexity will set you apart.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Director, Major Markets Europe & Canada
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in regulatory affairs, especially in the EU and Canada. We want to see how your background aligns with the specific requirements of the Director role.
Showcase Your Leadership Skills:This position is all about leading teams and managing stakeholders. Use your application to demonstrate your leadership experience and how you've successfully navigated complex regulatory environments in the past.
Be Clear and Concise:When writing your application, clarity is key! We appreciate straightforward language that gets to the point. Avoid jargon unless it’s relevant to the role, and make sure your achievements stand out.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity. Don’t miss out!
How to prepare for a job interview at 6010-Biosense Webster Inc. Legal Entity
✨Know Your Regulatory Stuff
Make sure you brush up on the EU MDR, UK, and Canadian regulatory requirements. Being able to discuss these in detail will show that you’re not just familiar with the regulations but can also navigate them effectively.
✨Showcase Your Leadership Skills
Prepare examples of how you've led teams or projects in the past, especially in complex regulatory environments. Highlight your ability to coach and develop others, as this role requires strong leadership capabilities.
✨Understand the Business Impact
Be ready to discuss how regulatory strategies align with business objectives. Think about how you can contribute to market access and growth while managing regulatory risks—this will demonstrate your strategic thinking.
✨Engage with Cross-Functional Teams
Since this role involves partnering with various stakeholders, prepare to talk about your experience collaborating with commercial, quality, and legal teams. Show that you can communicate effectively across different functions to drive compliance and performance.
