Regulatory Affairs Specialist II — MedTech Orthopaedics

Johnson & Johnson MedTech; Boston (MA); On-site; USD 76,000 - 122,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Job summary

Johnson & Johnson MedTech seeks a Regulatory Affairs Specialist II to support DePuy Synthes Joint Reconstruction and VELYS Digital Surgery product lines. You will execute regulatory activities for marketed devices and new developments, collaborating across teams to ensure compliant submissions and approvals.

The role requires evaluating regulatory impact of changes, maintaining knowledge of global standards, and guiding project teams through regulatory pathways in a dynamic environment.

Qualifications

• BA/BS degree with minimum 2 years Regulatory Affairs experience in medical devices.
• Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) required

Responsibilities

• Prepare regulatory documentation for DePuy devices (IDE, 510(k), PMA, Technical File, Design Dossier) and respond to regulatory questions.
• Assist EU CE marking and rest-of-world registrations as needed.
• Review engineering changes for regulatory impact and submit/regulatory decisions.
• Assess regulatory impact of manufacturing changes and maintain regulatory licenses status.
• Review labeling and product support information for compliance with regulatory clearances.
• Provide regulatory guidance to project teams and review promotional materials.
• Maintain knowledge of FDA QSR, ISO 13485, MDR/MDD and related standards.
• Communicate regulatory issues to management; ensure compliance with health, safety, and environmental guidelines.
• Support subordinates in regulatory activities and company policies; comply with all regulations.
• Perform other duties as needed.

Skills

Excellent written and oral COMM skills

Detail oriented

Regulatory knowledge

Medical devices familiarity

Electronic submissions

Education

BA/BS degree in a related field

Job description

Johnson & Johnson MedTech seeks a Regulatory Affairs Specialist II to support DePuy Synthes Joint Reconstruction and VELYS Digital Surgery product lines. You will execute regulatory activities for marketed devices and new developments, collaborating across teams to ensure compliant submissions and approvals.

The role requires evaluating regulatory impact of changes, maintaining knowledge of global standards, and guiding project teams through regulatory pathways in a dynamic environment.