Regulatory Affairs Director- G5+ Canada
Amersfoort - Netherlands
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Amersfoort Utrecht Netherlands Madrid Spain Zug SwitzerlandJob Description:
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.
- 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.
- Bachelors 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.
- Advanced degree (MBA Masters 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.
- 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 & Johnsons Credo values and ethical leadership.
At Johnson & Johnson youll have the opportunity to make a meaningful impact on patients lives while working alongside talented colleagues in a collaborative global environment. We are committed to fostering innovation professional growth inclusion and career development for our employees worldwide.
Johnson & Johnson is an Equal Opportunity Employer. We are committed to creating an inclusive environment where all employees and applicants are treated with respect and dignity.
Required Skills:
Preferred Skills:
Business Writing Collaboration 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 ThinkingThe anticipated base pay range for this position is:
101000.00 - 174800.00Benefits:
In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
Required Experience:
Director
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more