Regulatory Affairs Specialist Medical Devices Remote/Hybrid

NWS Management AG; Kraków; Hybrid; PLN 120,000 - 150,000; Full time

Benefits offered by this job

Hybrid work option

3 days on-site in Kraków

Job summary

NWS Management AG invites applications for a Regulatory Affairs Specialist (Medical Devices) based in Kraków. Join an international team and contribute to regulatory activities across Europe, Africa and ANZ in a supportive onboarding environment.

The role welcomes candidates with 1–2 years of Regulatory Affairs experience or comparable background. Remote or hybrid options are available, with 3 days on-site in Kraków. A 6‑month fixed-term contract with potential extension is offered.

Qualifications

• Bachelor’s degree in regulatory, scientific or technical discipline or equivalent experience.
• 1–2 years of Regulatory Affairs experience in medical devices preferred.
• Solid understanding of the EU MDR.
• Strong organisation and documentation skills.
• Collaborative mindset and willingness to learn.
• Interest in developing a career in Regulatory Affairs.

Responsibilities

• Support regulatory compliance activities for medical devices across Europe, Africa and ANZ.
• Assist with preparation, maintenance and submission of product registrations and regulatory documentation.
• Translate and legalise regulatory documents when required.
• Ensure product labelling and related documentation meet regulatory requirements.
• Maintain regulatory databases and product registration records.
• Respond to regulatory and technical enquiries.
• Support activities related to EU MDR.
• Collaborate with Regulatory Affairs colleagues.

Skills

Regulatory Affairs

EU MDR knowledge

Documentation

Team collaboration

English communication

Education

Bachelor’s degree in regulatory/scientific/technical discipline

Job description

NWS Management AG invites applications for a Regulatory Affairs Specialist (Medical Devices) based in Kraków. Join an international team and contribute to regulatory activities across Europe, Africa and ANZ in a supportive onboarding environment.

The role welcomes candidates with 1–2 years of Regulatory Affairs experience or comparable background. Remote or hybrid options are available, with 3 days on-site in Kraków. A 6‑month fixed-term contract with potential extension is offered.