Regulatory Affairs (Medical Devices)

Bothell, WA - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

Senior 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

Job Description Summary Senior 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...

Job Description Summary

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