Regulatory Affairs Specialist

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

For our client, a global leader in medical and protective solutions, we offer the opportunity to grow in an international, innovation-driven environment while contributing to products that protect healthcare professionals and patients worldwide.

Regulatory Affairs Specialist (a) - Medical Devices

You will join an experienced Regulatory Affairs team based in Kraków, working in a supportive environment with comprehensive onboarding, guidance and ongoing support. We welcome candidates with 1–2 years of professional experience, as well as applicants with comparable experience who are motivated to develop their career in Regulatory Affairs.

Key responsibilities

• Support regulatory compliance activities for medical devices across Europe, Africa and ANZ
• Assist with the preparation, maintenance and submission of product registrations, certifications and regulatory documentation
• Support the preparation, translation and legalisation of regulatory documents, where required
• Help ensure that product labelling and related documentation comply with applicable regulatory requirements
• Maintain regulatory databases and product registration records
• Respond to regulatory and technical enquiries
• Support activities related to the EU Medical Device Regulation (EU MDR)
• Collaborate with colleagues across the Regulatory Affairs team

Your profile

• A bachelor’s degree in a regulatory, scientific or technical discipline, or an equivalent combination of education and experience
• 1–2 years of professional experience in Regulatory Affairs or a related field, ideally within the medical device industry
• A good understanding of the EU MDR
• Good organisational skills, attention to detail and a structured approach to documentation
• A collaborative mindset, willingness to learn and the ability to manage tasks responsibly
• A genuine interest in developing a career in Regulatory Affairs
• Knowledge of regulatory requirements in the UK, Switzerland or ANZ is an advantage

What our client offers

• The opportunity to work with an experienced Regulatory Affairs team
• Comprehensive onboarding and ongoing support
• Opportunities to develop your regulatory knowledge and gain practical experience
• Remote or hybrid working options, with 3 days on-site in Kraków for hybrid working
• A 6-month fixed-term contract with the possibility of an indefinite extension

Work authorisation:

Applicants must have valid authorisation to work within the EU.