Regulatory Affairs Specialist
Company: NWS Management AG
- Location: Kraków, Poland
- Work mode: Hybrid
- Seniority: Mid level
- Employment type: Full-time
- Posted: 2 days ago
- Offer language: English
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
- Strong English communication skills
- 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
Candidates with less experience or a comparable background are encouraged to apply if they have strong English skills and the motivation to learn.
What our client offers
- The opportunity to work with an experienced Regulatory Affairs team
- Comprehensive onboarding and ongoing support
- An international, innovation-driven working environment
- 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.
If you are looking for an opportunity to develop your career in Regulatory Affairs and contribute to products that support safer healthcare, we encourage you to apply.
