Director Regulatory Affairs

Johnson & Johnson seeks a Director of Regulatory Affairs in Zuchwil, CH, to lead regulatory strategy for the Orthopaedics business unit, ensuring timely global product launches and team development.

This position sits within the Regulatory Affairs Group of the Orthopaedics division. The role is tasked with defining the regulatory strategy for product innovation, launch, and portfolio management. It also involves providing leadership to regulatory staff to ensure the timely commercialization of products in key markets.

Responsibilities

• Establish the strategic regulatory path for pipeline development and global launch success.
• Participate in various leadership teams, including those for Sports/Soft Tissue, Trauma, CMFT, Bio, and Spine.
• Collaborate with R&D and Global Strategic Marketing to create and execute strategies for pipeline and launch excellence.
• Apply complex independent judgment to influence the operational results of the business unit.
• Mentor and develop regulatory staff to prepare them for future leadership roles.
• Work with Policy teams to monitor global regulatory changes and assess their impact.
• Create and deploy training initiatives for cross-functional partners on regulatory requirements.
• Coordinate communication with global and local regulatory agencies.
• Ensure adherence to company policies and regulatory standards.
• Secure timely regulatory approvals for key product launches in major markets.
• Evaluate external innovation opportunities relevant to the area of responsibility.
• Represent the company in internal and external strategic forums.
• Serve as an expert resource on medical devices and biologics.
• Foster a culture of innovation, informed risk-taking, and continuous learning.
• Advise and challenge cross-functional partners to ensure optimal business decisions.

Requirements

• A bachelor’s degree is mandatory.
• At least 10 years of experience in a regulated industry.
• Prior experience with medical devices is required.
• A proven track record of creating global regulatory strategies aligned with business goals.

Nice to have

• An advanced degree is preferred.
• Experience with biologics, biomaterials, digital solutions, or Class 3 implantable devices is advantageous.
• Senior leadership experience, including line management, is preferred.
• Experience working with professional and trade associations is a plus.

What the company offers

• An inclusive work environment that values each individual.
• A commitment to an inclusive interview process that accommodates applicants’ needs.

About the company

Johnson & Johnson operates with the belief that health is paramount, aiming to prevent, treat, and cure complex diseases. Guided by its Credo, the company is responsible to its employees, respecting their diversity and dignity while recognizing their merit.

• The company believes health is everything and aims to build a world where complex diseases are prevented, treated, and cured.
• The company is guided by Its Credo and is responsible to its employees.
• The company respects the diversity and dignity of its employees and recognizes their merit.