Regulatory Affairs Analyst - Bothell
13 hours ago
Job description
Job Description SummarySenior Regulatory Affairs professional with 8+ years of experience in medical devices, specializing in US FDA, EU MDR, and APAC regulations.
Proven track record in leading 510(k), PMA, and EU Technical Documentation submissions, managing audits and inspections, and driving end-to-end regulatory compliance across the product lifecycle.
Strong cross-functional collaborator, experienced in global stakeholder engagement, regulatory strategy, post-market surveillance, and mentoring teams in complex, multi-market environments.Job Responsibilities – Regulatory Affairs (Medical Devices)
Develop and execute regulatory strategies for Class I, II, and III medical devices across US (FDA 21 CFR 820), EU MDR (2017/745), and APAC markets.
Lead preparation, review, and submission of 510(k), PMA, EU Technical Documentation, and Design Dossiers.Partner with R&D, Quality, Clinical, Manufacturing, and Market RA teams to ensure end-to-end regulatory compliance across the product lifecycle.
Independently assess regulatory impact of design, labeling, manufacturing, and process changes, ensuring timely documentation, submissions, and notifications.
Manage regulatory submissions planning, tracking, reporting, and approvals, providing regular status updates to global stakeholders.
Support and lead internal audits, FDA inspections, and Notified Body audits, including readiness preparation and closure of audit findings.
Review and approve product labeling, IFUs, and promotional materials for regulatory compliance.
Ensure compliance with UDI requirements and manage EUDAMED registrations and submissions.
Provide regulatory oversight for post-market surveillance, vigilance reporting, and adverse event investigations.
Act as primary regulatory liaison with FDA, Notified Bodies, and international regulatory authorities.
Retrieve, review, and manage regulatory documents from Philips Windchill, EU Technical Files, and DHFs.
Collaborate with global Market RA teams across time zones; flexibility to attend US-based and international meetings.
Mentor and guide junior regulatory professionals; deliver training on evolving regulatory standards and best practices.
Key Expectations
8+ years of regulatory experience in medical devices (US, EU, APAC)
Strong ownership of submissions, compliance, and audit readiness
Comfortable working across multiple time zones
Independent handling of complex regulatory deliverables
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