Senior Regulatory CMC Drug-Device Combination Product Lead
Core
Provide regulatory expertise for medical devices and combination products to support global regulatory strategies and ensure compliance.
Role type
Senior Regulatory CMC Device and Combination Product Lead
Builds
Global regulatory strategies and submissions for medical devices and combination products
Domain
Biotechnology / Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory experience in medical devices or combination products, cGMP understanding for devices, knowledge of applicable legislation and standards, analytical abilities, attention to detail
Preferred skills
Degree in Life/Health Sciences or Engineering
Responsibilities
Author and coordinate regulatory documentation and submissions, develop and execute regulatory strategies for new registrations and post-approval applications, monitor legislative and regulatory developments, participate in regulatory intelligence activities, develop and enhance regulatory processes
Seniority
Senior, Management level