Orthopedic MedTech Regulatory Specialist

Johnson & Johnson Co.; West Chester (Chester County); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson is seeking a Regulatory Affairs professional to oversee submissions for orthopedic devices across multiple regions. You will coordinate with Product Development, ensure compliance, and drive regulatory strategies to support lifecycle management. The role requires 4–6 years of experience, a bachelor’s degree or equivalent, and strong communication skills.

RAC certification is a plus. The position includes comprehensive pay and benefits and opportunities within DePuy Synthes as

Qualifications

• Bachelor’s degree or equivalent in a regulatory or life sciences field.
• 4–6 years of regulatory affairs work experience.
• RAC certification preferred.
• Excellent written and verbal communication skills.
• Ability to manage multiple tasks with strong attention to detail.

Responsibilities

• Prepare regulatory submissions to authorities for orthopedic devices.
• Provide regulatory input to product lifecycle planning and development.
• Develop regulatory strategies and adapt to changes in regulation.
• Review labeling, change controls, and submission timelines.
• Interface with Product Development to gather necessary data for submissions.
• Maintain regulatory databases and documentation for registrations.
• Explain regulatory requirements to internal stakeholders and guide decision making.

Skills

Excellent written and oral comms

Organizational skills

Detail oriented

Multitasking

Risk-benefit analysis

RAC certification (preferred)

Education

Bachelor's degree or equivalent

Job description

Johnson & Johnson is seeking a Regulatory Affairs professional to oversee submissions for orthopedic devices across multiple regions. You will coordinate with Product Development, ensure compliance, and drive regulatory strategies to support lifecycle management. The role requires 4–6 years of experience, a bachelor’s degree or equivalent, and strong communication skills.

RAC certification is a plus. The position includes comprehensive pay and benefits and opportunities within DePuy Synthes as