Sr. Manager Regulatory Affairs DACH/Switzerland

The company seeks a Manager for DACH Switzerland to lead regulatory affairs support, ensuring compliance with local requirements and enabling market access for medical products.

This position is responsible for overseeing regulatory affairs support for Switzerland within the DACH region. The role ensures adherence to local rules, manages regulatory risks, and collaborates with various stakeholders to maintain business continuity and support growth. It sits at the intersection of global strategy and local execution in a highly regulated setting.

Responsibilities

• Oversee regulatory activities for product registration, renewals, and lifecycle management in Switzerland.
• Maintain compliance with Swiss and regional regulations, internal policies, and quality standards.
• Act as the main regulatory contact for Switzerland within the DACH area.
• Manage regulatory submissions, variations, renewals, and responses to health authority inquiries.
• Collaborate with cross-functional teams such as Quality, Supply Chain, Commercial, and Global Regulatory Affairs.
• Track regulatory changes and evaluate their impact on products and operations.
• Support regulatory audits, inspections, and assessments as needed.
• Contribute to continuous improvement initiatives to enhance regulatory efficiency, compliance, and consistency.
• Engage in shaping regional policy initiatives critical to business strategy, continuity, and growth.

Requirements

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
• Typically 6-8 years of progressive experience in Regulatory Affairs within the medical device, healthcare, or other regulated industries.
• Strong knowledge of Swiss and EU regulatory requirements.
• Experience managing product registrations and lifecycle activities.
• Ability to interpret regulatory requirements and apply them to business and product decisions.
• Strong stakeholder management, communication, and collaboration skills.
• Ability to manage multiple priorities in a complex, fast-paced environment.
• English language proficiency is required.

Nice to have

• Advanced degree or professional certification in Regulatory Affairs.
• Experience supporting global or multi-country market portfolios.
• Experience working in a multinational or matrixed organization.
• Exposure to regulatory audits, inspections, or health authority interactions.
• Familiarity with EU MDR and related regulatory frameworks.
• Demonstrated experience driving regulatory or process improvement initiatives.
• German language proficiency is preferred.
• RAC or equivalent certification is preferred.

About the company

Johnson & Johnson operates under a Credo that emphasizes responsibility to its global workforce. The company fosters an inclusive environment where every individual is valued, diversity is respected, and merit is recognized.

• Guided by a Credo that emphasizes responsibility to employees worldwide.
• Provides an inclusive work environment where each person is considered as an individual.
• Respects the diversity and dignity of its employees and recognizes their merit.