Regulatory Affairs Manager

Job OverviewThe Regulatory Affairs Manager will be responsible for leading and managing a team of regulatory professionals to support compliance and market approval efforts for our diagnostic products. This role will oversee regulatory strategy development, submission preparation, and communication with global regulatory agencies. The manager will collaborate cross-functionally with R&D, Quality, Manufacturing, and Marketing teams to ensure all regulatory objectives align with business goals and compliance requirements.This position plays a key role in developing regulatory pathways for new product introductions, sustaining existing market authorizations, and maintaining adherence to industry standards in multiple global regions. The ideal candidate will bring expertise in regulatory affairs, leadership experience, and a commitment to continuous improvement.Key ResponsibilitiesStrategic & Operational LeadershipLead the development and execution of regulatory strategies for new and existing products to meet global compliance requirements.Ensure the timely preparation and submission of regulatory filings, including 510(k), IVDR Technical Documentation, and other regional regulatory submissions.Monitor evolving global regulatory requirements and develop action plans to maintain compliance.Partner with internal and external stakeholders to facilitate regulatory approvals and ensure compliance with evolving industry standards.Cross-Functional CollaborationWork closely with R&D, Manufacturing, Quality Assurance, and Marketing teams to align regulatory requirements with product development and commercialization strategies.Provide regulatory guidance for product labeling, marketing materials, and promotional content to ensure adherence to applicable regulations.Support audits, regulatory inspections, and post-market compliance activities as needed.Team & Process ManagementOversee a team of regulatory professionals, providing mentorship, training, and professional development opportunities.Foster a culture of accountability, teamwork, and continuous improvement within the regulatory team.Manage department budgets, staffing, and operational objectives to align with company priorities.Develop and maintain department procedures and policies to ensure compliance with internal quality systems and regulatory requirements.Required QualificationsEducation & CertificationsBachelor's degree in Biomedical Engineering, Biochemistry, Molecular Biology, or a related field (Master's degree preferred).Regulatory Affairs Certification (RAC) is a plus.ExperienceMinimum of 8 years of experience in Regulatory Affairs, with at least 5 years in the In Vitro Diagnostics (IVD) industry.Proven track record in obtaining regulatory approvals across major global markets, including the US, EU (IVDR), and other regions.Hands-on experience with regulatory submissions such as 510(k), IVDR Technical Documentation, and interactions with agencies such as FDA, EU Notified Bodies, and Health Canada.Experience leading and developing regulatory teams, including performance management and strategic oversight.Skills & CompetenciesIn-depth knowledge of global regulatory requirements for IVD products.Strong understanding of product development, analytical validation, and clinical validation processes.Excellent leadership, communication, and negotiation skills.Ability to work collaboratively across departments to drive regulatory success.Strong problem-solving skills and ability to navigate complex regulatory landscapes.Proficiency in Microsoft Office Suite and electronic document management systems.

Created: 2025-03-06