Regulatory Affairs Manager

Johnson & Johnson seeks a Regulatory Affairs Manager to lead teams in Oberdorf, CH, or the US, ensuring compliance and guiding product development within the DePuy Synthes Orthopaedics group.

This position sits within the Regulatory Affairs Group of the DePuy Synthes Orthopaedics team. The role may be located in Switzerland (Oberdorf or Zuchwil) or the United States. Following the separation of the Orthopaedics business, the successful candidate will likely become an employee of DePuy Synthes.

Responsibilities

• Directs a team to deliver independent regulatory advice to product development groups.
• Oversees the submission of licenses, authorizations, international registrations, and necessary dossiers.
• Ensures adherence to regulations during product development, labeling, and promotional activities.
• Identifies and defines the data required for regulatory approvals.
• Creates labeling specifications and reviews proposed labeling, packaging, and advertising materials.
• Schedules regulatory deliverables and tracks projects until completion.
• Establishes best practices for Regulatory Affairs processes.
• Represents Regulatory Affairs on cross-functional project teams.
• Collaborates with other functions to gather data for regulatory submissions.
• Provides support during internal and external audits.
• Communicates business issues or opportunities to higher management levels.
• Ensures compliance with Health, Safety and Environmental practices.

Requirements

• Bachelor’s degree or equivalent.
• 6 years of related experience.
• Experience in the Medical Device industry or medical field.

Nice to have

• Experience with power devices.
• Demonstrated knowledge of US and EU Medical Device Regulations.
• RAC (Regulatory Affairs Certification) or advanced degree in Regulatory Affairs.

What the company offers

• Inclusive work environment where each person is considered as an individual.
• Respect for the diversity and dignity of employees.

About the company

Johnson & Johnson 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 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.