Principal Regulatory Affairs Project Manager, Medical Devices
West Pharmaceutical Services
full-time
Posted on:
Location Type: Hybrid
Location: Exton • Pennsylvania • United States
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Job Level
Tech Stack
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory project executionregulatory dossiersdevelopment of medical devicesscale-up of medical devicesregistration of medical devicescombination products
Soft Skills
analytical skillscritical thinkingproblem-solvingleadershipcommunication
Certifications
Regulatory Affairs Certification (R.A.C)Project Management Professional (PMP)