Regulatory Manager

Main Responsibilities:

• Implement operational tasks, oversee all registration matters, set regulatory objectives with the RA/QA Director to meet company goals, and lead the regulatory team.
  Act as a Project Leader in diverse internal projects.
• Daily cooperation with Directors : R&D , Medical Affairs
• Ensure compliance with authorities and customers, communicate with Notified Bodies, Health Authorities and customers, handle FDA proceedings. Represent the company in regulatory matters and notify changes to regulatory agencies.
• Develop and improve regulatory processes, review the quality management system for regulatory effectiveness, coordinate internal and external audits, and manage corrective and preventive actions.
• Support new product development from a regulatory perspective.

Requirements:

• Master’s degree in life science /
  technical discipline or relevant.
• Managerial experience min 3 years 
• Minimum 8 years of demonstrated regulatory affairs experience in the Medical Device or Pharmaceutical industry.
• Excellent knowledge of MDR 2017/745 as well as ISO 13485.
• Experience in the registration of medical devices or pharmaceuticals in the EU and outside the European Union.
• Experience in auditing is an advantage.
• Minimum 8 years of demonstrated regulatory affairs experience in the Medical Device or Pharmaceutical industry.
• Excellent knowledge of MDR 2017/745 as well as ISO 13485.
• Experience in the registration of medical devices or pharmaceuticals in the EU and outside the European Union.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.