Prin Regulatory Affairs Specialist

W2 Only

Contract Role

Principal RA Specialist will play a key role in sustaining the current product portfolio. He/She has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining regulatory responsibilities include reviewing changes to ensure that regulatory requirements continue to be met, documenting no file decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. Responsibilities may include the following and other duties may be assigned.

• Provide strategic input and guidance on regulatory requirements for product modifications

• IDE and PMA Annual Reports, IDE and PMA Supplements, 510k, LTF, MDD and MDR STED updates and EU MDR submissions.

• Manage multiple projects and prioritize tasks to meet project schedul...