Regulatory Affairs Specialist - Medical Devices, Global

Lina Medical; Poznań; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Private medical care

Sports card

Flexible schedule

Home Office

Holiday support

English classes

Snacks

Job summary

Lina Medical is seeking a Regulatory Affairs professional to manage registrations and renewals across markets, and to drive regulatory activities in line with global requirements.

You will review and update regulatory documents, assess changes, and liaise with authorities and customers. The role includes audits, project leadership, and lifecycle regulatory support in an international environment.

Qualifications

• Master’s degree in life science or technical field.
• 3+ years regulatory experience in the Medical Device or Pharmaceutical industry.
• Experience with Regulatory Authorities and EU registrations.
• Familiar with MDR 2017/745 and EN ISO 13485.

Responsibilities

• Manage product registrations and renewals on selected markets.
• Lead regulatory activities per local and international requirements.
• Review and update regulatory documents and product technical files.
• Review changes for regulatory compliance.
• Communicate with authorities and customers (distributors, health authorities).
• Support audits and contribute to improving the Quality Management System.

Skills

Communication skills

Regulatory knowledge

Interpersonal skills

Time management

Attention to detail

Analytical skills

English fluency

Education

Master's degree in life science/technical field

Job description

Lina Medical is seeking a Regulatory Affairs professional to manage registrations and renewals across markets, and to drive regulatory activities in line with global requirements.

You will review and update regulatory documents, assess changes, and liaise with authorities and customers. The role includes audits, project leadership, and lifecycle regulatory support in an international environment.