Regulatory Affairs Senior Specialist

This position is designed to act as the primary regulatory point of contact for a range of Supply Chain (SC) projects, both regional and global. In this role, as a Regulatory Affairs Senior Specialist, you will assess and manage the regulatory impact of operational changes—whether related to product lifecycle, documentation, registration, or broader compliance requirements. As the RA Partner for SC you will engage in multiple cross-functional project groups and ensure RA is a proactive, solution‐oriented stakeholder providing clear and actionable guidance throughout the project lifecycle. This role provides exposure to global RA operations and offers a clear pathway toward leadership roles in regulatory operations or strategy. Key Responsibilities Lead as the primary RA resource within SC project teams. Drive the regulatory assessment and documentation of manufacturing changes and distribution requirements, ensuring global regulatory compliance (e.g. US FDA, EU MDR, TGA, Health Canada, ANVISA, ...). Collaborate with cross-functional teams such as quality, manufacturing, engineering, SC, and RA leads to gather input, align on regulatory requirements and resolve queries related to device changes, manufacturing transfers/issues or SC transformation projects. Contribute to regulatory planning, risk assessments, and documentation during product & process changes, and SC transformation projects. In close collaboration with RA leads, proactively identify and elevate regulatory risks linked to operational changes (e.g., site transfers, packaging updates, sourcing modifications, manufacturing / distribution issues) and ensure early alignment with impacted RA teams. Monitor changes in international regulations related to medical device manufacturing / distribution and communicate relevant updates to internal stakeholders. Provide regulatory preparation and documentation support for audits and inspections, including preparation of documentation and regulatory responses. Lead or support the regulatory activities, including submissions and facility licenses, related to device changes, manufacturing transfers/issues, new sites or SC transformation projects. Maintain & communicate regular updates with the RA teams regarding SC changes & agenda. Profile & Qualifications Bachelor or equivalent in Life Sciences, Biomedical Engineering, Regulatory Affairs or related field. Minimum 5+ years of experience in Regulatory Affairs or a regulated medical device environment, with exposure to manufacturing, distribution or regulatory operations. Proven experience in cross‐functional project environments, preferably with global exposure. Experience supporting global registrations and/or renewals, especially related to manufacturing transfers, SC transformation projects or process changes. Knowledge & Skills Foundational understanding of global medical device regulations (e.g. 21 CFR820, EU MDR, ISO 13485). Knowledge of regulatory operations, document management, and regulatory change control processes. Proficient in using document control systems and regulatory databases (e.g. EUDAMED, FDA FURLS). Capable of interpreting global requirements and integrating RA into business processes. Skilled in tracking milestones, managing priorities, and meeting deadlines. Strong written and verbal skills; able to influence and facilitate alignment. Pragmatic and solution‐driven, balancing regulatory compliance and business needs. Comfortable working across functions, time zones, and cultures. Experience or interest in supply chain is a plus. Behavioral Competencies / Leadership Attributes Collaborative and respectful of diverse perspectives. Calm, composed, and persistent when managing ambiguity. High ethical standards and zero tolerance for patient risk. Business‐oriented yet uncompromising on compliance principles. Strong judgment and stakeholder awareness. #LI-APAC Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now#J-18808-Ljbffr