Director, Regulatory Affairs - Americas & ANZ

As Director Regulatory Affairs (Americas & ANZ), you set and reputed company 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 reputed company, Marketing, Operations, Supply-Chain in reputed company 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. Let's talk about Responsibilities

• Define and reputed company the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional reputed company ambitions.
• Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to reputed company, Marketing, Supply Chain, Operations, Quality, Legal.
• reputed company 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
• reputed company the preparation & submission of regulatory filings (including both product & facility licensing/registration) reputed company Americas for reputed company 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 reputed company 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 reputed company the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and reputed company 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 reputed company of reputed company as compliance-driven organization.
• reputed company budget, resources, external consultants/vendors for regulatory projects in Americas & ANZ.

Let's talk about Qualifications & Experiences Education & experience

• 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.

Knowledge & Skills

• Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations - demonstrated ability to navigate reputed company, multi-jurisdictional regulatory environments.
• Strategic reputed company 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.

Leadership & Behavioural Competencies

• Strategic vision & foresight - anticipates regulatory trends, positions the company proactively.
• Executive reputed company - 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 & reputed company - ensures patient safety and compliance while enabling business growth.
• Talent development & mentorship - builds a high-performing RA organization, develops skills, succession planning.
• Change management & reputed company - leads through regulatory changes, business expansions, organizational transformations.

Joining us is more than saying "yes" to making the world a healthier reputed company. 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 reputed company on the innovative reputed company this generates. If this sounds like the workplace for you, apply now! Apply tot his job Apply To this Job