Senior Manager, Regulatory Affairs

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Regulatory Affairs based in United States.** This role offers the opportunity to lead global regulatory strategies that support the development and commercialization of innovative medical technologies. You will provide regulatory leadership across product lifecycles, ensuring compliance while enabling safe and efficient market access. The position combines strategic thinking, technical expertise, and cross-functional collaboration within a highly regulated healthcare environment. You will work closely with engineering, quality, clinical, operations, and business teams to integrate regulatory excellence into product development. Your expertise will help navigate complex regulatory landscapes, manage risks, and support sustainable business growth. This is a high-impact leadership opportunity for a regulatory professional passionate about improving healthcare outcomes through innovation. ### Accountabilities: The Senior Manager, Regulatory Affairs will provide strategic regulatory leadership for medical device portfolios, ensuring compliance with global regulations while supporting innovation, product development, and market access objectives. This role requires strong regulatory expertise, leadership capabilities, and the ability to influence stakeholders across global teams. - Develop and execute comprehensive global regulatory strategies aligned with business goals, product roadmaps, and market access requirements. - Lead regulatory pathways for U.S., EU, and international markets, including FDA Class I and II submissions, 510(k) processes, and EU MDR technical documentation. - Integrate regulatory requirements into early product development phases, including design controls, risk management, verification and validation planning, and technical documentation. - Identify regulatory risks, emerging requirements, and compliance challenges while developing effective mitigation strategies. - Act as the regulatory authority within cross-functional product teams, partnering with engineering, quality, operations, marketing, and clinical teams. - Evaluate regulatory impacts of product changes, manufacturing updates, supplier changes, labeling revisions, and lifecycle activities. - Oversee preparation, review, and submission readiness of regulatory dossiers and technical documentation. - Serve as a primary regulatory contact with health authorities, including FDA, EU Notified Bodies, and other international regulatory organizations. - Support post-market regulatory activities, including reporting obligations, corrective actions, field actions, inspections, audits, and compliance initiatives. - Mentor regulatory professionals and promote continuous improvement of regulatory processes, tools, and best practices. - Represent Regulatory Affairs across the organization by providing strategic guidance and regulatory expertise. ## Requirements: The ideal candidate is an experienced medical device regulatory leader with a strong understanding of global compliance requirements and a proven ability to guide complex regulatory initiatives. You should have excellent communication skills, strategic judgment, and experience operating in global, matrixed environments. - Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline; advanced degree preferred. - 8–10+ years of progressive regulatory affairs experience within the medical device industry. - Demonstrated experience leading FDA Class I and II submissions, including 510(k) submissions. - Experience with EU MDR (2017/745) technical documentation, conformity assessments, and global regulatory frameworks. - Direct experience engaging with FDA and EU Notified Bodies; experience with additional international regulatory authorities is preferred. - Strong knowledge of FDA regulations, including 21 CFR 820/QMSR, 21 CFR 807,…