Senior Regulatory Affairs Lead, MedTech Devices

Johnson & Johnson MedTech; Zuchwil; On-site; CHF 90,000 - 144,000; Full time

Benefits offered by this job

Vacation time benefits

Parental Leave

Sick time and holidays

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to coordinate regulatory submissions for medical devices, including new product introductions and lifecycle changes. Based in or supporting multiple sites, the role collaborates with Product Development and Regulatory bodies to ensure timely approvals and compliant labeling.

Required are a bachelor’s degree or equivalent, 4–6 years of experience, and strong communication and organizational skills. RAC certification is preferred.

Qualifications

• Excellent written and oral communication skills.
• Excellent organizational skills preferred.
• Ability to handle multiple tasks and be detail oriented.
• Ability to apply risk-benefit analysis techniques.
• RAC certification for Medical Devices preferred.

Responsibilities

• Coordinate regulatory submissions to regulatory authorities.
• Prepare registration documents and medical device listings; maintain registrations.
• Review and approve product labeling and change requests; ensure compliance.
• Interface with Product Development to obtain information for submissions.
• Develop regulatory strategies and update plans based on regulatory changes.
• Maintain regulatory databases with up-to-date information.
• Provide regulatory input to product lifecycle planning.

Skills

Excellent written and oral comms

Excellent organizational skills

Multi-tasking & detail oriented

RAC certification

Education

Bachelor’s degree or equivalent

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to coordinate regulatory submissions for medical devices, including new product introductions and lifecycle changes. Based in or supporting multiple sites, the role collaborates with Product Development and Regulatory bodies to ensure timely approvals and compliant labeling.

Required are a bachelor’s degree or equivalent, 4–6 years of experience, and strong communication and organizational skills. RAC certification is preferred.