Regulatory Affairs Specialist – Medical Devices (CEE)

jj; Warszawa; On-site; PLN 146,000 - 235,000; Full time

Benefits offered by this job

annual bonus

vacation days

parental leave

bereavement leave

caregiver leave

volunteer leave

well-being reimbursement

Job summary

Johnson & Johnson's DePuy Synthes division in Warsaw seeks a Regulatory Specialist to ensure regulatory compliance for medical devices in the CEE Central Region.

You will manage product notifications, submissions, and system updates, and work with cross-functional teams to support audits and the deployment of RA SOPs.

Requirements include 2+ years in Regulatory Affairs, fluent Polish and English, and strong communication skills.

Qualifications

• Regulatory knowledge of medical devices and RA environment.
• At least 2 years of experience in Regulatory Affairs.
• Excellent interpersonal and communication skills.

Responsibilities

• Ensure regulatory clearance of medical devices within timelines.
• Coordinate and prepare product notifications.
• Manage product submissions and RA databases.
• Provide regulatory support to teams and partners.

Job description

Johnson & Johnson's DePuy Synthes division in Warsaw seeks a Regulatory Specialist to ensure regulatory compliance for medical devices in the CEE Central Region.

You will manage product notifications, submissions, and system updates, and work with cross-functional teams to support audits and the deployment of RA SOPs.

Requirements include 2+ years in Regulatory Affairs, fluent Polish and English, and strong communication skills.