ResMed
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As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory strategy for the Americas (US, Ca & Latin America) & ANZ regions, enabling commercial growth & innovation, geographic expansion, and manufacturing/supply‑chain transformations while ensuring rigorous compliance with global and regional regulations. You serve as the senior RA business partner to executive leadership, drive proactive regulatory planning, and ensure that regulatory realities are embedded in business strategy across Revenue, Marketing, Operations, Supply‑Chain in close collaboration with Quality, legal and other regional & global RA leaders.Your role requires deep knowledge of medical device regulations in the US as well as a strong emphasis on strategic leadership, and hands-on execution across submissions, labelling and risk management processes.
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.
Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function
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.
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.
Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives.
Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners).
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.
Strategic vision & foresight — anticipates regulatory trends, positions the company proactively.
Executive presence — represents RA in senior leadership forums, builds credibility with regulators and internal stakeholders.
Collaborative leadership — fosters cross-functional alignment, builds influence without direct authority across functions.
Risk-based judgment & integrity — ensures patient safety and compliance while enabling business growth.
Talent development & mentorship — builds a high-performing RA organization, develops skills, succession planning.
Change management & resilience — leads through regulatory changes, business expansions, organizational transformations.
We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance. Employees have Flexible Time Off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.
Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.
At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this position is: 154,000.00 - 192,000.00 - 230,000.00 USD Annual.
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!
Originally posted on Himalayas