Senior Regulatory Affairs Lead, MedTech Orthopedics

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

Benefits offered by this job

Vacation time

Sick leave

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson in the Orthopaedics division seeks a Senior Regulatory Affairs Specialist to coordinate medical device submissions and navigate regulatory requirements across US entities. You will work with cross-functional teams to ensure compliance and timely approval.

The role requires 4–6 years of experience, a bachelor’s degree, RAC certification preferred, and strong communication and organizational skills. Expect a collaborative environment with competitive benefits.

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.
• Compile, prepare, review, and submit regulatory submissions.
• Monitor and respond to regulatory inquiries for orthopaedic devices.
• Interface with Product Development to obtain required information.
• Review changes and determine submission requirements.
• Review product labeling and documentation for regulatory compliance.
• Prepare registration documents and medical device listings.
• Maintain regulatory databases with up-to-date information.
• Develop and implement regulatory strategies based on changes.
• Provide regulatory input to product lifecycle planning.

Skills

Communication skills

Organizational skills

Attention to detail

Risk analysis

RAC certification

Education

Bachelor's degree or higher

Job description

Johnson & Johnson in the Orthopaedics division seeks a Senior Regulatory Affairs Specialist to coordinate medical device submissions and navigate regulatory requirements across US entities. You will work with cross-functional teams to ensure compliance and timely approval.

The role requires 4–6 years of experience, a bachelor’s degree, RAC certification preferred, and strong communication and organizational skills. Expect a collaborative environment with competitive benefits.