Senior Regulatory Affairs Specialist

Miejsce pracy: Wrocław

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.