Regulatory Specialist, MedTech (CEE) – Warsaw

Johnson Johnson; Warszawa; On-site; PLN 120,000 - 170,000; Full time

Job summary

Johnson & Johnson in Warsaw, Poland, is seeking a Regulatory Specialist to ensure regulatory compliance of medical devices across the CEE Central Region. You will manage product notifications, submissions, and system updates while maintaining RA databases.

You will provide regulatory support to Tender, Health Economics & Reimbursement, Business, Distributors and Franchises, and deliver RA trainings. Strong collaboration and timely communication with partners will be essential.

Qualifications

• Demonstrable knowledge of Regulatory, understanding of Medical Devices environment.
• At least 2 years of experience in Regulatory Affairs environment.
• Excellent interpersonal skills - build and maintain relationships with internal and external partners.
• Detailed planning and execution to achieve accurate and timely results.
• Sense of importance and mission of the role.
• Advanced knowledge of Microsoft Word, Excel and related functions.
• Excellent organizational skills and attention to detail.
• Excellent communication skills - both written and oral, and the ability to collaborate closely with internal and external parties.
• Languages: Polish and English required , additional CEE languages beneficial
• Ability to understand cross-enterprise data flow and system.
• The embodies values, ethic and trust.

Responsibilities

• Ensure regulatory clearance of medical devices within timelines; coordination and preparation of product submissions.
• Provide regulatory support to relevant teams and partners - Tender, Health Economics & Reimbursement, Business, Distributors and Franchises and deliver RA trainings to local clusters.
• Provide communication and updates to management regarding regulatory affairs.
• Monitor legislative situation, lead projects related to compliance and ensure that RA SOPs are updated and followed.

Skills

Regulatory Affairs

Medical Devices

English

Polish

Cross-functional Collaboration

Documentation

MS Word/Excel

Attention to detail

Stakeholder management

Communication

Tools

MS Word

Excel

Job description

Johnson & Johnson in Warsaw, Poland, is seeking a Regulatory Specialist to ensure regulatory compliance of medical devices across the CEE Central Region. You will manage product notifications, submissions, and system updates while maintaining RA databases.

You will provide regulatory support to Tender, Health Economics & Reimbursement, Business, Distributors and Franchises, and deliver RA trainings. Strong collaboration and timely communication with partners will be essential.