Opis stanowiska

Rekrutacja zdalna

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.