Project Manager overseeing project execution in textile and fashion industries at CYBEX. Leading teams, managing budgets, and coordinating cross - functional efforts for successful project delivery.
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Hybrid Principal Regulatory Affairs Project Manager, Medical Devices
Posted 1 hour ago
About the role
- 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
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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