Lead cross-functional regulatory project teams in the development and execution of global regulatory strategies
Drive end-to-end regulatory project execution for high-impact programs
Direct the preparation and submission of complex regulatory dossiers
Ensure submissions meet quality standards and regulatory expectations
Lead interactions with external customers, partners and regulatory agencies
Drive continuous improvement initiatives within the regulatory function

Bachelor's or Master’s degree in science, engineering, or related discipline
Bachelors Degree with minimum 5 years experience or Master’s Degree with minimum 3 years experience
Experience in the area of development, scale-up and registration of regulated medical devices and combination products
Proficiency in using project management software and regulatory tools
Strong analytical, critical thinking, and problem-solving skills
Regulatory Affairs Certification (R.A.C) and/or Project Management Professional (PMP) Certification

Principal Regulatory Affairs Project Manager, Medical Devices

Key skills