West Pharmaceutical Services is seeking a Principal Specialist in Regulatory Affairs for medical devices, requiring a hybrid work model with at least three days on-site in Exton, PA. The role focuses on developing regulatory strategies, preparing global submissions, and ensuring compliance with regulations, while also mentoring team members
Job Summary
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.
The Principal Specialist ensures timely and high-quality execution of all regulatory deliverables, mentors team members, and provides support for global regulatory approvals.
West offers generous paid time off, global career opportunities, an inclusive and collaborative culture, and recognition and rewards.
Matching Summary
Match Score: 85
West Pharmaceutical Services is seeking a Principal Specialist in Regulatory Affairs for medical devices, requiring a hybrid work model with at least three days on-site in Exton, PA. The role focuses on developing regulatory strategies, preparing global submissions, and ensuring compliance with regulations, while also mentoring team members.
Skills & Requirements
Must-have
Develop regulatory strategies for medical devices
Prepare global submissions
Ensure regulatory compliance
Interact with government agencies
Review product labeling and promotional material
Nice-to-have
Inclusive and collaborative culture
Opportunities for lifelong learning
Giving back to the community
Key Requirements
Minimum 8 years related work experience
Medical device or Combination Product regulatory experience preferred
Bachelor's with 4-6 years experience or Master's degree/PhD 3-4 years medical device regulatory experience
US FDA regulations (Title 21CFR820) and EU MDD (93/42/EEC) and MDR (2017/745)
History of successful US 510(k) device and EU technical documentation submissions
RAPS Regulatory Affairs Certifications (RAC)-Medical Devices - Upon Hire preferred