In this role, you will be responsible to
assist with product complaints and mdr management system, quality metrics, reporting, perform product inspections and qsr audits, good documentation practices, issue audit reports and special projects.
This position is responsible to acquire/maintain/audit company licensing and product registration. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the companys ongoing compliance. Provide guidance to Operations and other areas of the company on compliance issues with relation to area of expertise.
The successful candidate must have global regulatory experience working in IVD, Medical Devices or Pharmaceutical, with a history of successful regulatory submissions, registrations, 510(k)s and PMA approvals in US and Asia.
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
In this role, you will be responsible for
Preparing submissions( i.e. PMA, PMA supplements, CE marking applications, etc. ) to obtain various worldwide approvals to commercially distribute products.In conjunction with Clinical Research, support the preparation of applications.
In this role, you will prepare documentation meeting regulatory requirements, identifying and using existing documentation where possible, or managing creation of new documentation; provide to foreign Regulatory affiliates to support product registration.
In this role, you will review and evaluate communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.