OverviewAt Houston Methodist, the ACM Regulatory Affairs Specialist is responsible for coordinating and implementing regulatory strategies and processes to ensure timely manufacturing, and distribution of products in compliance with applicable regulations and standards. Under the direction of department leadership, this position will implement and coordinate quality and regulatory compliance programs applicable to the medical device and drug industry. Interface with the FDA and international regulatory agencies. Work with cross-functional teams to prepare regulatory submissions. Provides support during external assessments, audits, and/or inspections. Performs administrative duties required for direct supervision of Regulatory Affairs personnel and support staff.