Description
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 GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Diegem, Flemish Brabant, Belgium, Zuchwil, SwitzerlandJob Description:
Position Overview
Johnson & Johnson MedTech is recruiting for an Associate Director, Regulatory Affairs, MSM – Electrophysiology (EP).
This role is responsible for ensuring the timely registration and market access of medical devices across the MSM region in compliance with applicable European, FDA, national, and regional regulatory requirements. The successful candidate will provide strategic regulatory leadership, support regulatory policy shaping activities, and partner closely with business stakeholders to ensure ongoing regulatory compliance and successful execution of business objectives.
The Associate Director will play a key role in regulatory strategy development, external regulatory engagement, regulatory compliance oversight, and leadership of a regional Regulatory Affairs team.
Key Responsibilities
- Lead regulatory affairs activities across the MSM region to support business growth and market access objectives.
- Drive regulatory shaping and outreach initiatives through engagement with Health Authorities, regulatory agencies, and industry trade associations.
- Assess and communicate the impact of changing regulatory requirements on products, registrations, licenses, and business operations.
- Partner with global and regional Regulatory Affairs teams, commercial teams, distributors, and business partners to provide regulatory guidance and strategic support.
- Act as Regulatory Affairs Lead or representative on cross-functional projects and regulatory initiatives.
- Ensure compliance of the medical device portfolio with applicable regulatory requirements and company policies.
- Provide regulatory support for tenders, reimbursement activities, distributors, commercial operations, and franchise teams.
- Lead continuous improvement initiatives to strengthen regulatory processes and operational excellence.
- Ensure audit and inspection readiness and represent Regulatory Affairs during internal audits and Health Authority inspections.
- Communicate regulatory compliance updates, risks, and recommendations to leadership and key stakeholders.
- Oversee the Copy Review process and support compliant promotional and non-promotional communications.
- Identify, assess, and escalate regulatory risks while driving effective mitigation plans.
- Lead, coach, and develop direct reports while fostering a high-performing and collaborative team environment.
- Identify opportunities for process optimization and cost efficiencies.
- Ensure compliance with all applicable quality, legal, ethical, and Healthcare Compliance (HCC) requirements.
Required Qualifications
Education
- Bachelor's degree in Life Sciences, Engineering, Pharmacy, Regulatory Affairs, or a related discipline.
Experience
- Minimum of 6 years of progressive Regulatory Affairs experience within the Medical Device industry or other highly regulated healthcare environments.
- Demonstrated experience interpreting and applying local, regional, and European medical device regulations.
- Prior people management experience with responsibility for team leadership and development.
- Experience supporting regulatory submissions, registrations, and lifecycle management activities.
Knowledge, Skills & Competencies
- Strong knowledge of EU Medical Device Regulations and regulatory compliance requirements.
- Ability to assess regulatory requirements and translate them into actionable business guidance.
- Established relationships or experience interacting with Competent Authorities and industry associations.
- Excellent communication and stakeholder management skills.
- Strong organizational skills with exceptional attention to detail.
- Strategic mindset with the ability to balance short-term priorities and long-term objectives.
- Strong problem-solving, critical thinking, and decision-making capabilities.
- Results-driven with a strong sense of urgency and accountability.
- Fluent English, both written and spoken.
Preferred Qualifications
- MBA, Master's degree, or other advanced scientific or business degree.
- Experience within Electrophysiology, Cardiovascular, or broader MedTech businesses.
- Experience leading regulatory policy shaping, advocacy, or outreach initiatives.
- Experience supporting multiple countries or regional regulatory activities.
- Proven success leading teams in a matrixed global organization.
Leadership Expectations
The successful candidate will demonstrate:
- Strong people leadership and talent development capabilities.
- Ability to influence across functions and organizational levels.
- Collaborative and inclusive leadership style.
- Strong business partnership skills.
- Ability to navigate complexity and drive execution in a fast-paced environment.
- Commitment to Johnson & Johnson Credo values and ethical leadership.
Why Join Johnson & Johnson?
Join a global organization that is shaping the future of healthcare and delivering innovative solutions that improve lives. This role offers the opportunity to influence regulatory strategy, engage with external stakeholders, and contribute directly to bringing innovative medical technologies to patients across the region.
Johnson & Johnson is an Equal Opportunity Employer and is committed to creating an inclusive environment for all employees and applicants.
Required Skills:
Preferred Skills:
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking