Wrocław, Wrocław
Manpower
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.