Regulatory Affairs Specialist — Hybrid (Global)

Demant Polska; Szczecin; Hybrid; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid working model

Flexible hours

Permanent contract after 3 months

Private medical health care

Sport card

Job summary

Demant Polska in Szczecin is seeking a dedicated Regulatory Affairs Specialist to join our small, international team responsible for regulatory strategy and project support across the product development process.

You will manage classification activities, risk management, clinical evaluation, device registrations, and audits, with flexible hours, hybrid work near the city center, and opportunities for learning. English is used daily in this global environment.

Qualifications

• Experience in Regulatory Affairs or regulated industries is a plus.
• Bachelor degree in medicine, chemistry, pharmacy or similar.
• Proficient with MS Office and documentation systems.
• Excellent spoken and written English for daily communication.

Responsibilities

• Maintain technical documentation for medical devices including private label products.
• Manage regulatory project strategy, classification, risk management, and review of marketing materials.
• Participate in regulatory projects and design change reviews (ECO).
• Support RAP, RACA, RAFR teams with deliverables.

Skills

Regulatory affairs

Good English

Analytical skills

Communication skills

Team player

Education

Bachelor degree (medicine, chemistry, pharmacy)

Tools

MS Office

Database systems

Documentation systems

Job description

Demant Polska in Szczecin is seeking a dedicated Regulatory Affairs Specialist to join our small, international team responsible for regulatory strategy and project support across the product development process.

You will manage classification activities, risk management, clinical evaluation, device registrations, and audits, with flexible hours, hybrid work near the city center, and opportunities for learning. English is used daily in this global environment.