Regulatory Affairs Sr. – Medical Devices (Hybrid)

Demant Polska; Rosówek; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Onboarding program

Professional development

Hybrid work model

International team

Exposure to MDR/ISO standards

Daily English use

Full-time employment

Job summary

DGS Diagnostics, based in Rosówek near Szczecin, seeks a (Senior) Regulatory Affairs Specialist to ensure international regulatory compliance across product lifecycles. You will collaborate with global teams and work in an English-speaking, international environment.

Join our growing medical device unit to advance regulatory affairs expertise, support labeling and IFU creation, and influence registrations and audits in a multinational setting.

Qualifications

• Experience in Regulatory Affairs within the medical device industry or another regulated environment.
• Knowledge of medical device regulations, MDR and ISO standards.
• Professional proficiency in English, both written and spoken.
• Strong communication skills and relationship-building abilities.

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.
• Ensure country specific details and info are updated.
• Provide support during labelling and IFU creation/modification.
• Support organization in Regulatory Affairs related issues.
• Ensure that we have a business behind all registrations (incl. re-registrations).
• Cooperate with notifying body and quality during audits.

Skills

Strong communication

Analytical mindset

Attention to detail

Proactive attitude

Education

Bachelor's/Master's in Life Sciences

Job description

DGS Diagnostics, based in Rosówek near Szczecin, seeks a (Senior) Regulatory Affairs Specialist to ensure international regulatory compliance across product lifecycles. You will collaborate with global teams and work in an English-speaking, international environment.

Join our growing medical device unit to advance regulatory affairs expertise, support labeling and IFU creation, and influence registrations and audits in a multinational setting.