Senior Regulatory Affairs Specialist

You will be leading the Regulatory Affairs department. You will be responsible for assuring product compliance with various current or updated regulatory requirements (e.g.MDR, BPR). In addition, you will directly prepare and maintain technical files, ensure that technical and QMS documentation follows all current obligatory guidelines, and regulations.

Your main responsibilities will be:

• Preparing and maintaining technical documentation together with the team
• Conducting Post-Market Surveillance
• Maintaining a Quality Management System for the Regulatory Affairs Department;
• Assuring product"s compliance with relevant regulatory requirements (medical device, biocides)
• Co-operating with other departments, delegating tasks and keeping the team accountable regarding deadlines
• Working in close collaboration with the Danish branch

Requirements:

• Master"s Degree in Life science, or a related field with a minimum of 5 years of relevant work experience
• Good research and data analyzing skills
• Spoken and written English required (B2)
• Ability to critically analyze documentation in English
• Good understanding of the quality management system principles
• Good knowledge of ISO 13485:2016 standard
• Good knowledge of Medical Device Regulation (EU) 2917/745
• Good knowledge of CE marking process
• Experience with preparing and maintaining QMS and technical files
• Experience with audits and Notified Bodies
• Meticulous attention to detail is essential
• Structured and consistent mindset
• Ability to learn fast on your own
• Ability to lead and support your team
• Capacity to plan and organize work
• Ability to prioritize and delegate tasks

Offer:

• A modern, cosy office downtown
• Friendly, open-minded and international work-environment
• International trips, audits, trainings and conferences
• Substantial impact on the department strategy and product development
• Competitive salary
• Relocation package up to 10000 PLN
• Flexible working hours
• Private medical care
• MultiSport card
• Life insurance
• Meal passes / Cafeteria benefits system
• Free language courses and consultations
• Extra days off within a year
• Fruits, snacks and beverages in the office
• Team-building meetings
• No dress code