Sr Regulatory Affairs Specialist

Source: https://jobs.medtronic.com/jobs/associate-regulatory-prooduct-and-operations-specialist-25904

Medtronic

Type

Corporate / senior

Location

North America

Woburn

United States

Location

United States

Woburn

Type

Corporate / senior


Ensure Medtronic compliance to FDA and other international regulations. Prepare and submit regulatory dossiers to support international regulatory registrations and FDA submissions which may include device 510(k), IDEs, etc. in supporting business growth. Serve as regulatory representative on selected projects for new product development or line extension. Provide regulatory supervision on post-market product changes to maintain ESSENTIAL FUNCTIONS: Prepare, review and file appropriate FDA premarket submission to ensure devices are commercially available in the U.S.: 510(k)s, pre-IDEs, IDEs, or PMAs and PMA Supplements. Create regulatory dossiers, i.e. technical files or Design Dossier for CE Marking; generate STED to support business access to international markets. Maintain communication with regulatory agencies during regulatory submission. Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. Provide regulatory support for risk management activities and clinical evaluation Represent Regulatory Affairs as core team member of new product development projects to drive innovation and to support Design Control process. Develop Regulatory Strategies for new or modified products and assist on project planning. Address questions or demands from external and internal customers Collaborate with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally. Prepare Regulatory Rational for product modifications without submission when appropriate. Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information. Support Inspections by notified body, FDA and other regulatory agencies.