Associate Director, DACH

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. Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy, continuity, and growth.

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. 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.

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline (required).

• 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.

• Experience supporting global or regional regulatory operating models (preferred).

• Experience working in multinational medical device or healthcare organizations (preferred).

• Exposure to regulatory inspections, audits, and authority negotiations (preferred).

• Demonstrated success driving regulatory transformation or process improvement initiatives (preferred).

• Regulatory Affairs Certification (RAC) or equivalent (preferred).

• Strong leadership, stakeholder management, and decision‑making skills (preferred).

• Language: English required; German preferred.

• Moderate regional travel across DACH markets.