Collabera Senior International Regulatory Affairs Associate in Raritan, New Jersey
Senior International Regulatory Affairs Associate
Location:Raritan, New JerseyUS
The Senior International Regulatory Affairs Associate will contribute to Company’s regulatory strategies and content plans from an international perspective (ex-US), supporting all business fields. The primary responsibility is managing the coordination, compilation and submission of regulatory applications to regulatory agencies worldwide.
Interpret Regulatory requirements and determine strategy to obtain registrations.
Partner with medical device Market Quality contacts, third parties, and distributors worldwide to develop regulatory strategies, resolve regulatory matters, and submit and maintain product registrations to gain and maintain market access for medical device products defined in the commercial business case.
Assist in representing Company to domestic and international regulatory agencies, including Notified Bodies.
Provide guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approvals for planning purposes.
Execute activities related to maintaining compliant regulatory status for marketing products worldwide, including annual reporting, change management/change notifications, labeling review, copy review, etc.
Support Regulatory Transition for emerging markets, while supporting global Regulatory Transition strategies.
Support and/or lead departmental initiative, such as process improvement, as required.
Bachelor’s degree in a Scientific or related discipline. Master’s Degree is desirable.
4-6 years of experience in a regulated Medical Device Industry, IVD Industry experience preferred.
A working knowledge of US/EU/WW Regulations, FDA and WW guidance for Medical Devices (IVDs specifically), IVD Directive required.
Experience developing regulatory strategies and an understanding of Product Development is preferred.