Associate Director, DACH

The Associate Director, DACH role at Johnson & Johnson provides regulatory leadership across Germany, Austria, and Switzerland, ensuring compliance and enabling market access for DePuy Synthes products.

This position serves as the senior regulatory escalation point for the DACH Local Market Support within the International QARA organization. The role partners with commercial, quality, and global teams to manage regulatory risk, shape strategy, and support execution in a complex regulatory environment.

Responsibilities

• Lead and oversee regulatory affairs strategy and execution across DACH local markets in alignment with global regulatory objectives.
• Ensure compliance with country-specific and EU regulatory requirements, internal policies, and quality system standards.
• Provide strategic regulatory guidance to support product registrations, renewals, variations, and lifecycle management.
• Serve as the senior regulatory escalation point for DACH Local Market Support within the International QARA organization.
• Partner with cross-functional stakeholders including Commercial, Quality, Supply Chain, Legal, and Global Regulatory Affairs.
• Monitor regulatory changes across DACH markets and assess potential impacts to products, portfolios, and operations.
• Support regulatory inspections, audits, and health authority interactions as required.
• Lead, coach, and develop regulatory talent, fostering strong compliance, accountability, and performance.
• Ensure proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
• Typically 8–10 years of progressive experience in Regulatory Affairs within the medical device, healthcare, or other regulated industries.
• Strong knowledge of EU MDR and regulatory requirements across Germany, Austria, and Switzerland.
• Demonstrated experience leading multi-country or regional regulatory portfolios.
• Proven ability to develop and execute regulatory strategies aligned to business objectives.
• Ability to operate effectively in a global, matrixed organization.
• English required.

Nice to have

• Advanced degree or professional certification in Regulatory Affairs.
• Experience supporting global or regional regulatory operating models.
• Experience working in multinational medical device or healthcare organizations.
• Exposure to regulatory inspections, audits, and authority negotiations.
• Demonstrated success driving regulatory transformation or process improvement initiatives.
• Regulatory Affairs Certification (RAC) or equivalent.
• Strong leadership, stakeholder management, and decision-making skills.
• German preferred.

About the company

Johnson & Johnson is responsible to its employees who work with them throughout the world. The company provides an inclusive work environment where each person is considered as an individual. They respect the diversity and dignity of their employees and recognize their merit.

• Johnson & Johnson is responsible to its employees who work with them throughout the world.
• The company provides an inclusive work environment where each person is considered as an individual.
• They respect the diversity and dignity of their employees and recognize their merit.