• Support regulatory strategy for new products and changes (devices, drugs, combination products, digital health/SaMD). • Help prepare FDA and international submissions (e.g., 510(k), Q-/Pre‑Subs, MDR/IVDR files) and maintain product registrations. • Contribute to EU technical documentation (Technical Files, CERs, Declarations of Conformity). • Help maintain and improve QMS (e.g., ISO 13485, FDA QSR, GMP); draft/update SOPs and templates. • Support internal and external audits, CAPA activities, and remediation. • Assist with Code of Conduct and global policy development (e.g., anti‑bribery, HCP interactions, conflicts of interest, third‑party risk). • Help create and deliver training and communications (e‑learning, live sessions, guides, intranet content). • Support conflicts‑of‑interest processes, hotline and investigations tracking, risk assessments, and culture/engagement surveys. • Partner with Legal, Quality, Medical, Commercial, HR, Finance, IT and others to review projects and contracts for compliance considerations.