Associate Director, Regulatory Affairs, MSM- Electrophysiology

Johnson & Johnson seeks an Associate Director for Regulatory Affairs in Zuchwil to lead MSM region strategy, ensure compliance with EU and FDA regulations, and manage a regional team for medical device market access.

This position provides strategic regulatory leadership for the MSM region, focusing on the timely registration and market access of medical devices. The role involves shaping regulatory policy, ensuring ongoing compliance with European, FDA, and local requirements, and partnering with business stakeholders to support growth objectives. The incumbent will also lead a regional team and drive continuous improvement in regulatory processes.

Responsibilities

• Direct regulatory affairs operations across the MSM region to facilitate business expansion and secure market access.
• Engage with health authorities, regulatory agencies, and industry associations to influence regulatory frameworks and outreach.
• Evaluate and communicate how evolving regulatory standards impact product registrations, licenses, and operational workflows.
• Collaborate with global and regional regulatory groups, commercial teams, and distributors to deliver strategic guidance.
• Serve as the primary regulatory representative on cross-functional projects and initiatives.
• Maintain compliance of the medical device portfolio with all relevant regulatory mandates and internal company policies.
• Provide regulatory expertise for tenders, reimbursement processes, and commercial franchise activities.
• Spearhead initiatives to enhance regulatory processes and achieve operational excellence.
• Prepare for and lead internal audits and health authority inspections, ensuring full readiness.
• Report regulatory risks, compliance updates, and mitigation strategies to senior leadership and stakeholders.
• Oversee the copy review process to ensure promotional and non-promotional materials meet compliance standards.
• Identify, assess, and escalate regulatory risks while implementing effective mitigation plans.
• Lead, mentor, and develop direct reports to foster a high-performing and collaborative team culture.
• Seek opportunities to optimize processes and improve cost efficiencies.
• Adhere to all quality, legal, ethical, and Healthcare Compliance (HCC) requirements.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Regulatory Affairs, or a related field.
• At least six years of progressive experience in Regulatory Affairs within the medical device sector or other highly regulated healthcare environments.
• Proven ability to interpret and apply local, regional, and European medical device regulations.
• Prior experience in people management, including team leadership and development.
• Background in supporting regulatory submissions, registrations, and lifecycle management.
• Strong understanding of EU Medical Device Regulations and general compliance requirements.
• Fluent proficiency in English, both written and spoken.

Nice to have

• MBA, Master's degree, or other advanced scientific or business qualification.
• Experience in Electrophysiology, Cardiovascular, or broader MedTech industries.
• Track record in leading regulatory policy shaping, advocacy, or outreach efforts.
• Experience managing regulatory activities across multiple countries or regions.
• Success in leading teams within a matrixed global organization.

What the company offers

• Chance to influence regulatory strategy, engage with external stakeholders, and contribute to bringing innovative medical technologies to patients.
• Join a global organization dedicated to shaping the future of healthcare and delivering solutions that improve lives.

About the company

Johnson & Johnson is committed to its employees worldwide, providing an inclusive work environment that respects diversity and dignity. The company values each individual, recognizes merit, and adheres to its Credo values and ethical leadership principles.

• Commitment to employee well-being and global responsibility.
• Inclusive work environment that values individual contributions.
• Respect for diversity and recognition of employee merit.
• Adherence to Johnson & Johnson Credo values and ethical leadership.