Principal Regulatory Affairs Project Manager leading complex regulatory programs for medical devices and combination products. Collaborating across teams to ensure compliance and strategic execution.
Responsibilities
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
Requirements
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
Benefits
health insurance
retirement plans
paid time off
flexible work arrangements
professional development
wellness programs
Job title
Principal Regulatory Affairs Project Manager, Medical Devices
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