ResMed

Compensation

Full Description

Job Description: • 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