Senior Regulatory Affairs Specialist – Medical Devices (Hybrid)

West Pharmaceutical Services; Exton (PA); Hybride; USD 120 000 - 160 000; Plein temps

Avantages offerts par ce poste

Community involvement

Learning & development

Generous PTO

Diversity & inclusion

Résumé du poste

West Pharmaceutical Services seeks a Regulatory Affairs Senior Specialist to influence regulatory processes and support global registrations, including Premarket Notifications and Post Market Submissions. The role mentors team members and ensures compliance with regulations, while handling internal and external regulatory requests.

The position requires developing strategies for transfer devices and authoring US/EU/China submissions, collaborating with QA and R&D to ensure compliant filings and

Qualifications

• Bachelor’s or Master’s degree or PhD in science, math, engineering, or related discipline or equivalent experience.
• Bachelor’s with minimum 5 years; Master’s degree/PhD with minimum 3 years of medical device, pharmaceutical or regulatory experience.

Responsabilités

• Develop and implement regulatory strategies for medical devices and ensure timely approvals.
• Author and review US, EU, China, and other international submissions.
• Provide leadership to product development teams for regulatory issues and questions.
• Maintain regulatory databases and documentation for new or modified products.
• Communicate project progress and decisions to management and stakeholders.

Connaissances

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Formation

Bachelor’s degree in science/engineering

Outils

Master Control

Adobe

SharePoint

MS Teams

Outlook

Description du poste

West Pharmaceutical Services seeks a Regulatory Affairs Senior Specialist to influence regulatory processes and support global registrations, including Premarket Notifications and Post Market Submissions. The role mentors team members and ensures compliance with regulations, while handling internal and external regulatory requests.

The position requires developing strategies for transfer devices and authoring US/EU/China submissions, collaborating with QA and R&D to ensure compliant filings and