Regulatory Specialist, Medical Devices - CEE Focus

7815-Johnson & Johnson Poland Sp. z o.o. Legal Entity; Starachowice; On-site; PLN 146,000 - 235,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Job summary

Johnson & Johnson Poland Sp. z o.o. Legal Entity is seeking a Regulatory Specialist to ensure regulatory compliance for medical devices in the CEE Central region, based in Warsaw.

The role handles device notifications, submissions, and RA process improvements, collaborating with multiple internal teams and partners. The position requires Polish and English proficiency, with at least 2 years in Regulatory Affairs and strong writing and communication skills for effective regulatory interactions

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.

Responsibilities

• Ensure regulatory clearance of medical devices within timelines.
• Coordination and preparation of product notifications.
• Managing product submissions.
• Responsible for updates and approvals in systems linked to job duties and maintaining RA databases.
• Review of copy review materials for CEE Central region.
• 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

Stakeholder management

Communication

Analytical reasoning

Detail-oriented

Teamwork

Tools

Microsoft Word

Microsoft Excel

Job description

Johnson & Johnson Poland Sp. z o.o. Legal Entity is seeking a Regulatory Specialist to ensure regulatory compliance for medical devices in the CEE Central region, based in Warsaw.

The role handles device notifications, submissions, and RA process improvements, collaborating with multiple internal teams and partners. The position requires Polish and English proficiency, with at least 2 years in Regulatory Affairs and strong writing and communication skills for effective regulatory interactions