Senior Regulatory Affairs Consultant

Hello, We are looking for a new colleague, your responsibilities will be:

• Develop and implement regulatory affairs services and related capabilities according to current and future market needs and trends 
• Support business development on regulatory affairs related services 
• Consult with clients to develop regulatory strategies, identifying the most efficient and compliant pathways for bringing their medical devices and pharmaceutical products to market. 
• Consult with clients on the clinical data necessary to support device and drug approval.  
• Consult with clients in implementation of additional components beyond the standard ISO 13485, that incorporates Artificial Intelligence (AI), i.e. focus on data management, AI-specific risk management, ethical considerations  
• Prepare, review, and submit high-quality regulatory submissions for global registration, including 510(k) Notices, PMA applications, De Novo requests, IND applications, and NDA submissions. 
• Serve as the main liaison between clients and regulatory authorities, facilitating effective communication and swift resolution of issues. 
• Support clients in the post-market surveillance and reporting process, including guidance on MDRs, recalls, inspections, and adverse event reporting for pharmaceutical products. 
• Keep abreast of changes regulatory guidelines, standards, and policies, interpreting their implications for client projects. 
• Provide training to clients' internal teams on FDA regulations, guidelines, and processes. 

​​• Company bonus (based on company financial results)
​​• Referral bonus depending on level of person referred
​​• Business mobile (also for private calls) and laptop
​​• Heath-/Dentalcare costs coverage (up to 250EUR/year)
​​• Employer's contribution to III. pension pillar
​​• Allowance for sport and leisure activities (up to 200EUR/year)
​​• 3 sick days per calendar year
​​• 2 extra days off for your wedding
​​• Social events (team-buildings and team-dinners)
​​• Budget for trainings & certifications
​​• Monthly events in our office in Kosice
​​• Home Office upon agreement (or possibility to work from our office in Kosice)
​​• Flexible working hours
​​• Become part of an established company with a start-up mindset (Self-organizing, flat hierarchy)
​​• Ice Hockey tickets discount (HC Kosice home games)
​​• 7 compensated days for training purposes​​