Global Medical Devices Regulatory Affairs Lead

Demant Polska; Rosówek; Hybrid; PLN 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

Onboarding support

Global exposure

English-speaking environment

Job summary

DGS Diagnostics, based in Rosówek near Szczecin, invites a (Senior) Regulatory Affairs Specialist to join our international team and ensure our medical device products meet global regulatory requirements throughout their lifecycle.

You will work with colleagues across Europe, support MDR/FDA/ISO compliance, and contribute to labeling, IFU updates, and registrations, while enjoying a hybrid work model and English-speaking environment.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Healthcare, Engineering, or a related field.
• Experience in Regulatory Affairs within medical devices or regulated environments.
• Knowledge of MDR, FDA requirements, and ISO standards.
• Professional proficiency in English, both written and spoken.

Responsibilities

• Ensure regulatory requirements are fulfilled for medical device products.
• Ensure design changes are properly managed and communicated according to regulatory requirements.
• Cooperate in RA Intelligence process, collecting and listing in newsletter & action log.
• Update country-specific details and regulatory information.
• Provide support during labeling and IFU creation/modification.
• Support organization (e.g. Customer Service and Technical Documentation) in relation to Regulatory Affairs issues.
• Ensure that we have a business behind all registrations (incl. re-registrations).
• Cooperate with notifying body and quality during audits.

Skills

Regulatory Affairs

MDR/ISO knowledge

English communication

Analytical mindset

Stakeholder management

Education

Bachelor's/Master's in Life Sciences/Healthcare/Engineering

Job description

DGS Diagnostics, based in Rosówek near Szczecin, invites a (Senior) Regulatory Affairs Specialist to join our international team and ensure our medical device products meet global regulatory requirements throughout their lifecycle.

You will work with colleagues across Europe, support MDR/FDA/ISO compliance, and contribute to labeling, IFU updates, and registrations, while enjoying a hybrid work model and English-speaking environment.