Strategic Regulatory Affairs Lead – Medical Devices

West Pharmaceutical Services / Progressive Medical; Exton (PA); Hybrid; USD 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Community involvement

Continuous learning & development

Generous PTO

Inclusive culture

Hybrid work arrangement

Zusammenfassung

West Pharmaceutical Services is seeking a Principal Regulatory Affairs Project Manager for a hybrid role onsite at least 3 days per week. You will lead cross-functional teams to drive global regulatory strategies, manage complex submissions for medical devices and combination products, and ensure timely delivery across markets.

Ideal candidates bring 5+ years in regulatory affairs (3+ with a Master’s), strong project management and leadership skills, and experience with regulatory tools.

Qualifikationen

• Bachelor’s degree in science/engineering or related field required; Master’s preferred.
• 5+ years in regulatory affairs for medical devices or combination products with bachelor’s, or 3+ years with master’s.
• Experience leading regulatory submissions and cross-functional programs.
• Proficient in PM software and regulatory tools; strong communication and leadership skills.

Aufgaben

• Lead cross-functional regulatory project teams across global markets.
• Drive end-to-end regulatory execution from development through post-market.
• Prepare and submit complex regulatory dossiers and respond to information requests.
• Anticipate risks and implement mitigation strategies; escalate as needed.
• Collaborate with R&D, QA, clinical, and manufacturing to align regulatory plans.

Kenntnisse

Regulatory project management

Cross-functional leadership

Strategic regulatory planning

Risk management

Strong communication

Team leadership

Ausbildung

Bachelor's degree in science/engineering

Master’s degree (preferred)

Tools

Regulatory submission tools

Project management software (MS Project, etc.)

Jobbeschreibung

West Pharmaceutical Services is seeking a Principal Regulatory Affairs Project Manager for a hybrid role onsite at least 3 days per week. You will lead cross-functional teams to drive global regulatory strategies, manage complex submissions for medical devices and combination products, and ensure timely delivery across markets.

Ideal candidates bring 5+ years in regulatory affairs (3+ with a Master’s), strong project management and leadership skills, and experience with regulatory tools.