Senior Director RA, EMEA/Canada EP/NV

8542-Actelion Pharmaceuticals Ltd Legal Entity; Allschwil; Vor Ort; CHF 180.000 - 270.000; Vollzeit

Zusammenfassung

Johnson & Johnson MedTech is seeking a Senior Director RA, EMEA/Canada EP/NV to lead regional regulatory activities across EMEA and Canada. The role oversees strategy, submissions, lifecycle management, and market access, aligning with senior business leaders to drive growth.

The candidate should possess extensive leadership experience in regulatory affairs, global/regional collaboration, and a track record of successful regional strategies across multiple markets.

Qualifikationen

• Bachelor's degree required in a relevant field.
• MBA or advanced degree preferred.
• 15+ years in a regulated industry with leadership experience.
• Experience in Medical Device RA and multi-region submissions is a plus.

Aufgaben

• Lead regional Regulatory Affairs teams across EMEA and Canada to support growth and approvals.
• Represent RA in global/regional leadership discussions and drive governance.
• Develop regional regulatory strategy reflecting country and cultural dynamics.
• Ensure ongoing product compliance by monitoring regulatory changes and impact.
• Build diverse regional regulatory talent and promote development.
• Engage with external regulatory forums and trade associations.

Kenntnisse

Senior leadership

Regulatory strategy

Global/regional leadership

Regulatory submissions

Budget management

Ausbildung

Bachelor's degree

MBA or advanced degree preferred

Jobbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com. 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 Group

Job Sub Function

Regulatory Affairs

Job Category

People Leader

All Job Posting Locations

Allschwil, Basel-Country, Switzerland

Job Description

Johnson & Johnson MedTech is recruiting a Senior Director RA, EMEA/Canada EP/NV to be based in Ireland, Switzerland, or Israel supporting the Electrophysiology (EP) and Neurovascular (NV) businesses. The Senior Director RA, EMEA/Canada EP/NV serves as the regulatory leader for the region, overseeing all aspects of regulatory activities in these markets. This role actively contributes to the development and execution of regulatory strategies, engages closely with senior business leaders, and exercises significant independent judgment to drive business outcomes.

Key Responsibilities

• Responsible for leading the regional Regulatory Affairs teams across EMEA and Canada to support and enhance business growth and accelerate product approvals by providing strategic leadership, ensuring effective prioritisation and governance, building capability, and driving the delivery of strategic and operational plans, including submissions, approvals, lifecycle management, and market access maintenance.
• Represents the regional RA organisation in global and regional leadership discussions, contributing market insights, shaping governance discussions, and driving implementation of agreed strategic and operational priorities.
• Lead regional regulatory strategy development, ensuring regional, country, and cultural dynamics are reflected in strategic and operational plans that advance global Business Unit priorities, market needs, and business objectives.
• Ensure ongoing product compliance by monitoring regulatory change, assessing business and market impact, and directing appropriate regional actions.
• Create a diverse, vibrant, and capable regional regulatory workforce by promoting the importance of recognising and embracing cultural differences, strengthening strategic capability and execution discipline, and building a sustainable talent pipeline through active recruitment, retention, and development strategies.
• Represents Business and J&J MedTech strategies in external regulatory forums, global & regional trade associations, and in regulatory authority meetings.
• Drive regulatory operating model excellence by advancing scalable processes, digital capabilities, and data-driven transparency to improve efficiency and enable strategic decision making.

Other Duties

• Responsible for regional RA budget planning and control, ensuring regulatory activities are delivered within timeline and budget, and determining and communicating the financial implications of regulatory activities on business results. Ensures that company policies, procedures and practices follow global policies and regional requirements. Provides advice, analysis and guidance to senior leadership on critical cross functional project. Perform ad-hoc tasks assigned by Regional and Global Boards as appropriate.

Qualifications & Experience

• Required Minimum Education: Bachelor's degree.
• Preferred advanced degrees and education in medicine, engineering, science or law highly preferred.
• Other: MBA or advanced degree preferred
• Required Years of Related Experience: A minimum of 15 years of experience in a regulated industry, with a minimum of 3 years’ experience in management positions including managing people.

Required Knowledge, Skills and Abilities

• Senior leadership experience is required, especially interacting with senior leaders and influencing strategy and decision making at senior levels
• Demonstrated track record of formulating regional regulatory strategies that align with business deliverables is required
• Medical Device experience preferred but not required. Global franchise / business unit RA experience supporting an OUS market with diversity of experience - i.e. sector, company, function, product
• Regulatory compliance risk evaluation and balanced decision making
• Experience leading diverse teams in a matrix environment, cultural awareness, Talent Mgmt in competitive markets
• Large budget cost center management and business planning in a complex financial model
• Regional or multi market experience with Regulatory Affairs, including Emerging markets.
• Experiences and leadership in working with external industry groups and International organizations is a plus; Outreach, influencing, negotiation, shaping, collaboration with Health authorities or industry trade groups
• Strong English language (spoken and written) capability; other languages of regional countries are welcomed
• Live the credo in a way that creates a trusting, collaboratively and ethical work environment
• Prior hands-on Cardiovascular submission experience, with a track record of obtaining approvals across multiple regions (US, Europe, UK, APAC).

Travel on the Job

Yes Percentage Traveled: 25%

Preferred Skills

• Business Writing
• Compliance Risk
• Cross-Functional Work
• 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
• Risk Management
• Strategic Thinking