5+ years of developing global regulatory submissions for medical device industry
Experience and knowledge of product and process regulatory compliance
Proactively review global regulatory requirements/changes. Conduct gap analysis and effectively communicate requirements/changes to key stake holders.
Develop regulatory submission strategies for new and existing software medical devices, and manage to completion. This includes US, Canada, EU, Brazil, Australia, and other international territories that require registration.
Provide guidance as needed to key stakeholders as submission deliverables are developed.
Review deliverables prior to inclusion in regulatory submissions.
Compile and submit regulatory filings to regulatory authorities and country representatives.
Serve as point of contact for regulatory agency requests for additional information.
Review product and process changes and determine impact to regulatory filings.
Review product and process changes to determine if regulatory agency notification is required.
Review and approve labeling, including but not limited to user manuals and marketing literature.
Participate in post-market surveillance activities including reviews and reports.
Participate in internal audit program and external agency QARA audits.
Understand and practice requirements of EN ISO 13485, Process Flows and Work Instructions.