Job title:
Senior Regulatory Affairs Specialist
Company:
Manpower
Job description
Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami – to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!Key Responsibilities:
- Prepare, update, and maintain regulatory documentation (including Technical Documentation, DoC, GSPR) in line with EU MDR requirements
- Route regulatory documents for internal approval using PLM systems
- Conduct regulatory assessments as part of the Change Control process
- Collaborate with cross-functional teams (Quality, Operations, R&D) and external partners (suppliers, distributors) to gather required documentation for compliance and regulatory submissions
- Review product labeling and promotional materials to ensure compliance with MDR, CPR, BPR, and national regulations
- Respond to global market registration requests, including the preparation of supporting documentation
- Lead or support the planning and implementation of Regulatory Affairs initiatives at the divisional or regional level
- Develop, write, and update regulatory processes and procedures in response to regulatory changes or identified gaps
- Independently define project plans, justifications, timelines, and resource needs to meet regulatory objectives
Requirements:
- Qualifications: A PhD with at least 5 years of experience/ Master’s degree with at least 10 years of experience/ Bachelor’ s degree with at least 15 years of experience
- Fluent English skills – at least B2/C1 level (written and spoken)
- University degree in biology, engineering, biotechnology, or a related field
- Advanced knowledge and extensive hands-on experience with EU MDD 93/42/EEC and EU MDR 2017/745 compliance for medical devices
- Proven experience working with Notified Bodies and Competent Authorities on regulatory submissions, audits, and inspections
Nice to have:
- Understanding of Clinical Evaluation processes in line with MEDDEV 2.7/1 rev. 4
- Hands-on experience with compliance under EU CPR and EU BPR regulations
- Experience in authoring Technical Documentation and managing related notifications/registrations
Offer:
- Employment based on a temporary employment contract for a period of 18 months
- Opportunity to gain valuable experience in an international company
- Attractive salary, depending on experience and skills
- Possibility to work 100% remotely (if you live more than 50 km from Wrocław) or in a hybrid model (if you live in Wrocław or within a 50 km radius)
- Comprehensive onboarding training
- Benefits package including MultiSport card, private medical care, and life insurance
The offer concerns temporary employment.
Expected salary
Location
Wrocław, dolnośląskie
Job date
Sun, 20 Jul 2025 07:03:53 GMT
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