ResMed

Director, Regulatory Affairs – Americas, ANZ

ResMed

full-time

Posted on:

Location Type: Remote

Location: Remote • California • 🇺🇸 United States

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Job Level

Lead

About the role

  • Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions.
  • Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal.
  • Lead strategic high-complexity/ high-risk regulatory projects.
  • Oversee the preparation & submission of regulatory filings (including both product & facility licensing/registration) within Americas for all class and type of Products.
  • Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate.
  • Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs; propose harmonization initiatives for labeling, documentation, submission processes across region.
  • Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls).
  • Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands.
  • Serve as primary liaison with regulatory authorities (FDA, Health Canada, LATAM authorities) for major regulatory interactions, pre‑submission meetings, escalations, and to build trust and reputation of ResMed as compliance‑driven organization.
  • Oversee budget, resources, external consultants/vendors for regulatory projects in Americas & ANZ.

Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent; advanced/regulatory certification (e.g., RAC) highly desirable.
  • Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM).
  • At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders.
  • Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments.
  • Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage.
  • Willingness to travel across Americas region; flexible to address regulatory or business needs globally as required.
Benefits
  • Health insurance
  • Flexible work arrangements
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory affairsregulatory filingsrisk managementregulatory intelligenceaudit readinesscompliance frameworkmedical device regulationspolicy monitoringsubmission processestalent development
Soft skills
leadershipmentoringperformance managementcross-functional collaborationstrategic planningcommunicationinfluencingcrisis managementrelationship buildingadaptability
Certifications
Bachelor’s degreeMaster’s degreeRAC certification