Director, Regulatory Affairs – Americas, ANZ

Job reputed company: • Define and reputed company the Regulatory Affairs roadmap for Americas in alignment with global corporate reputed company and regional reputed company ambitions. • Represent Regulatory Affairs in regional leadership, reputed company planning and strategic cross-functional meetings including but not limited to reputed company, Marketing, Supply Chain, Operations, reputed company, reputed company. • reputed company strategic high-complexity/ high-risk regulatory reputed company. • 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 reputed company with regulatory authorities (FDA, Health Canada, LATAM authorities) for major regulatory interactions, reputed company‑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 reputed company 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 reputed company reputed company, 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 • reputed company development opportunities Apply tot his job Apply To this Job