Senior Manager, Regulatory Affairs
Core
Develop and execute global regulatory strategies for high-complexity hardware and software products (IVDs, digital pathology) to enable commercialization in clinical oncology.
Role type
Senior Manager, Regulatory Affairs
Builds
Global regulatory submissions (510k, EU IVDR Technical Files, STED) for diagnostic technologies
Domain
Life sciences / Diagnostics / Biotechnology
Required skills
Global regulatory strategy, FDA and EU regulatory requirements for IVD devices, global submission preparation, cross-functional collaboration, stakeholder negotiation, regulatory compliance, product development lifecycle management
Preferred skills
Clinical trial support, international market regulatory requirements, matrixed environment leadership, change management, strategic risk-benefit analysis
Technologies
510k, EU IVDR, STED, IDEs, Performance Study Applications
Responsibilities
Lead a team of Regulatory Affairs Professionals in developing and maintaining global regulatory submissions; Collaborate globally with Clinical Affairs, Business Development, QA, R&D, and Program Management; Provide regulatory input for program planning including budgets and timelines; Engage and negotiate with global regulatory agencies to achieve product clearance/approval
Seniority
Senior, hands-on IC with team leadership