Regulatory Affairs Specialist - Medical Devices (CEE)

Johnson & Johnson MedTech; Warszawa; On-site; PLN 146,000 - 235,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being programs

Job summary

Johnson & Johnson is recruiting a Regulatory Specialist for Warsaw, Poland, to ensure regulatory compliance of medical devices in the CEE Central region. The role involves coordinating product notifications, system updates, and providing RA support to cross-functional teams across tender, health economics, and distributors.

The ideal candidate has 2+ years in Regulatory Affairs, strong communication, and proficiency in English and Polish.

Qualifications

• 2+ years of experience in Regulatory Affairs environment.
• Demonstrable knowledge of Regulatory, understanding of Medical Devices environment.
• Excellent interpersonal and communication skills – both written and oral.

Responsibilities

• Ensure regulatory clearance of medical devices within portfolio and coordinate notifications.
• Maintain RA databases and update related systems.
• Provide regulatory support to cross-functional teams and deliver RA trainings as needed.
• Assist during internal and external audits and ensure compliance with RA SOPs.

Skills

Regulatory affairs

Medical devices

Stakeholder management

Detail planning

Regulatory compliance

Microsoft Word

Microsoft Excel

Tools

Microsoft Word

Microsoft Excel

Job description

Johnson & Johnson is recruiting a Regulatory Specialist for Warsaw, Poland, to ensure regulatory compliance of medical devices in the CEE Central region. The role involves coordinating product notifications, system updates, and providing RA support to cross-functional teams across tender, health economics, and distributors.

The ideal candidate has 2+ years in Regulatory Affairs, strong communication, and proficiency in English and Polish.