Opis:
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
29 lip 2025;
from:
www.jobs.pl