Location: Pleasanton CA
Duration: 12 Months
Experience: 10 years professional experience in medical devices Regulatory Affairs (RA).
Education: Bachelor's /Master's degree or equivalent;
RAC certification preferred.
Expert level global regulatory submissions experience required.
Works as team lead on regulatory submissions deliverables to ensure compliant, successful, on-time market clearance/approval.
Is a regulatory subject matter expert regarding active medical devices including software. Capable of handling multiple requests from regulatory agencies, simultaneous product registrations and submissions to regulatory bodies.
Also able to maintain registrations and device listings, support the reporting of departmental metrics, support and backup for other Q&R functions, supports internal/external audits and regulatory inspections.
Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
Provide significant regulatory strategy development and support.