Regulatory Associate

Experis ManpowerGroup Sp. z o.o.; Remote; PLN 120,000 - 180,000; Full time

Job summary

A leading staffing agency seeks a professional in regulatory affairs to coordinate communication and implement regulatory strategies for medical devices and cosmetics. The ideal candidate will have a bachelor's degree, 1-2 years of relevant experience, and the ability to work remotely. Responsibilities include supporting product changes, managing documentation, and ensuring compliance with regulations. This position offers a competitive salary of 8600–9500 zł brutto, private healthcare, and additional benefits including a multisport card and e-learning resources.

Benefits

Private healthcare

Multisport card

Life insurance

PowerYou – e-learning platform

Qualifications

• 1-2 years of regulatory affairs experience in any environment.
• Knowledge of US and OUS medical device regulations.
• Certified Regulatory Affairs professional (RAC) preferred.

Responsibilities

• Coordinate regulatory affairs for US and OUS.
• Implement regulatory strategies and support new product introductions.
• Review and approve product labelling.

Skills

Regulatory strategy experience

Fluent English

Strong communication skills

Collaboration skills

Education

Bachelor's degree or higher

Tools

SAP

Regulatory databases

UDI systems

Job description

100% remote

8600 – 9500 zł brutto

Responsibilities:

• Coordinate medical device and cosmetic regulatory affairs for US and OUS.
• Coordinate communication internal and external to the regulatory function.
• Implement regulatory strategies.
• Support new product introductions and existing product changes.
• Partner to determine global regulatory strategy.
• Participate in minimum change documentation.
• Support risk management files and completion.
• Support UDI.
• Review and approve product labelling.

Requirements:

• Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution.
• 1-2 years of regulatory affairs experience in a private, public, government or military environment.
• Ability to read, write, and speak English fluently.
• Fundamental understanding of US and OUS medical device and cosmetic regulatory affairs.
• Certified Regulatory Affairs professional (RAC).
• Advanced degree in scientific discipline.
• Experience with regulatory strategy.
• Experience with electronic systems (e.g., SAP, data acquisition systems, regulatory databases, UDI systems).
• Strong communication and collaboration skills.

What we offer:

• 100% remote work
• Private healthcare
• Multisport card
• Life insurance
• PowerYou – e-learning platform