Yochana · 13 hours ago
Regulatory Affairs Analyst
Bothell, WA
Contract
Onsite
Senior Level, Lead/Staff
8+ years expYochana is a company specializing in regulatory affairs for medical devices, and they are seeking a Senior Regulatory Affairs Analyst. The role involves developing and executing regulatory strategies for medical devices, leading submissions, managing audits, and ensuring compliance across various markets.
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Responsibilities
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
Qualification
Required
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
Experience managing audits and inspections
Strong cross-functional collaboration skills
Experience in global stakeholder engagement
Ability to 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
Experience in preparing, reviewing, and submitting 510(k), PMA, EU Technical Documentation, and Design Dossiers
Ability to independently assess regulatory impact of design, labeling, manufacturing, and process changes
Experience managing regulatory submissions planning, tracking, reporting, and approvals
Experience supporting and leading internal audits, FDA inspections, and Notified Body audits
Ability to review and approve product labeling, IFUs, and promotional materials for regulatory compliance
Experience ensuring compliance with UDI requirements and managing EUDAMED registrations and submissions
Experience providing regulatory oversight for post-market surveillance, vigilance reporting, and adverse event investigations
Ability to act as primary regulatory liaison with FDA, Notified Bodies, and international regulatory authorities
Experience retrieving, reviewing, and managing regulatory documents from Philips Windchill, EU Technical Files, and DHFs
Ability to collaborate with global Market RA teams across time zones
Experience mentoring and guiding junior regulatory professionals
Ability to deliver training on evolving regulatory standards and best practices
Strong ownership of submissions, compliance, and audit readiness
Comfortable working across multiple time zones
Independent handling of complex regulatory deliverables
Company
Yochana
Yochana: Your Trusted Workforce Partner Across North America & Beyond For over 16 years, Yochana has been a leading talent acquisition firm, connecting businesses with top professionals across industries.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Anusha Sharath
Global Talent Acquisition Lead / HR-BP
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