Regulatory Affairs Officer

About the role

LiNA Medical Polska, a manufacturer of minimally invasive gynaecological medical devices, was looking for a Regulatory Affairs Officer in Poznan, Poland. The recruitment has ended and this is now an archived listing, but the job description remains available.

Key responsibilities

• Manage product registrations and renewals on selected markets
• Lead regulatory activities in line with local and international requirements
• Review and update regulatory documents and product technical files, and keep compliance with regulatory directives and regulations
• Review product and manufacturing changes and approve Change Requests
• Maintain relationships with external customers, including distributors and health authorities such as the FDA, Health Canada and Notified Bodies
• Improve the regulatory aspects of the Quality Management System and supporting documentation
• Assist with audits, act as project leader in internal projects and give regulatory advice across the product lifecycle
• Support post-market surveillance and the clinical evaluation process

Required profile

• Master's degree in life sciences, a technical discipline or a relevant field
• At least 3 years of regulatory experience in the medical device or pharmaceutical industry
• Experience working with regulatory authorities and registering medical devices or pharmaceuticals in the EEA and outside the EU
• Fluent English, oral and written

Required skills

• Familiarity with MDD 93/42/EEC, MDR 2017/745 and EN ISO 13485
• Knowledge of standards and quality systems
• Auditing experience is an advantage
• Strong communication, planning, analytical and problem-solving skills

What we offer

• Full-time job contract
• International environment and opportunities to grow within the organisation
• Benefits such as private medical care, sports card, flexible working hours, home office, holiday co-financing and English language classes
• Internal and external training