Regulatory Affairs Leader - ARC

Role: Provide strategic regulatory leadership for global medical technology products, overseeing premarket submissions, post-market compliance, and regulatory program implementation. Responsibilities: develop regulatory strategies to optimize submission pathways, ensure compliance with global regulatory requirements, support regulatory activities such as registration planning, audits, labeling, and advertising review; collaborate with cross-functional teams and communicate with leadership; assess product changes for licensing needs; contribute to technical documentation and background research for submissions. Requirements: Bachelor's degree or equivalent with at least 3 years of experience in regulated environments; strong knowledge of regulatory processes in medical devices or digital health; excellent communication, project management, and organizational skills; ability to work independently in a fast-paced setting. Preferred: experience in global regulatory strategy, medical device regulation, and liaising with regulatory agencies. High-Value: focus on medical devices, digital solutions, global regulatory compliance, premarket and post-market activities, cross-functional team collaboration, and technical documentation. Work Setup: not specified, but implied to be an office-based role with global stakeholder interaction.