Sr Manager Regulatory and Clinical Affairs

The Quality and Regulatory Affairs team at Thermo Fisher Scientific is seeking a Senior Manager, Regulatory and Clinical Affairs to develop and execute regulatory strategy and clinical evidence generation plans to support product claim expansions and regulatory submissions across the portfolio. This role will be responsible for recommending global regulatory pathways, identifying clinical evidence requirements, coordinating clinical study planning and execution, and ensuring that study outputs support high-quality submissions to regulatory authorities.

Regulatory Strategy and Submission Leadership

• Develop and execute regulatory strategies for product claim expansions, new indications, expanded intended use, and new market access opportunities, in partnership with Regulatory Affairs leadership.
• Recommend appropriate global regulatory pathways, submission requirements, evidence expectations, and agency interaction strategies for assigned programs.
• Translate business priorities and product strategy into actionable regulatory plans, including timelines, risks, assumptions, and recommendations for decision points.
• Lead and coordinate preparation of assigned regulatory submissions, responses to regulator questions, and supporting documentation packages, with oversight from Regulatory Affairs leadership as appropriate.
• Assess product claims, intended use statements, labeling, promotional claims, and submission content to confirm they are supported by appropriate analytical, clinical, and scientific evidence.
• Monitor evolving regulatory requirements and guidance relevant to clinical evidence, product claims, diagnostic performance, and market access, and communicate potential impact to project teams and leadership.

Clinical Affairs and Evidence Generation

• Develop and execute clinical evidence strategies to support regulatory submissions for product claim expansions, New Product Development (NPD), and new market access, in partnership with Regulatory Affairs, Medical Affairs, and Biostatistics stakeholders.
• Develop, coordinate, and oversee assigned clinical study plans, protocols, study designs, statistical analysis plans, clinical performance evaluation strategies, and clinical study reports.
• Manage assigned clinical operations resources and external partners to ensure studies are delivered on time, within scope, and in compliance with applicable regulatory, quality, ethical, and data integrity requirements.
• Coordinate clinical data review, monitoring, cleaning, analysis, and interpretation to ensure outputs are submission-ready.
• Collaborate with clinical sites, investigators, CROs, laboratories, and internal stakeholders to support effective study startup, execution, closeout, and reporting.
• Confirm clinical study documentation supports regulatory submissions, clinical performance claims, risk-benefit assessments, and post-market obligations.
• Identify clinical evidence gaps and recommend practical strategies to close those gaps.

People and Program Leadership

• Manage, coach, and develop assigned Regulatory Affairs and Clinical Affairs team members and/or project resources.
• Lead cross-functional project teams responsible for claim expansion and clinical evidence programs.
• Establish clear project plans, milestones, deliverables, owners, and escalation pathways.
• Prepare and communicate program status, risks, decision recommendations, and trade-offs to leadership and governance forums.
• Partner with Product Management and commercial stakeholders to evaluate and prioritize claim expansion opportunities based on customer need, regulatory feasibility, clinical evidence burden, cost, timeline, and business impact.
• Partner with Quality and R&D to ensure regulatory and clinical requirements are integrated into design control, change control, risk management, and validation activities.
• Influence stakeholders across functions and regions to support alignment, resolve issues, and maintain submission momentum.

Qualifications

• Bachelor's degree in life sciences, clinical research, regulatory affairs, biomedical science, medicine, or a related field; advanced degree preferred.
• 8+ years of experience with in vitro diagnostics, laboratory diagnostics, companion diagnostics, monitoring claims, or related diagnostic technologies; 10+ years preferred.
• Experience with FDA submissions, including 510(k), De Novo, PMA supplements, Q-Submissions, or other regulatory interactions.
• Experience with EU IVDR, clinical performance studies, performance evaluation reports, and/or global IVD regulatory requirements.
• Experience managing or coordinating CROs, clinical sites, external laboratories, investigators, or clinical vendors.
• Experience with biostatistics, clinical performance evaluation, analytical performance, risk management, and labeling/claims development.

Physical Requirements/Work Environment: Office based role with one day hybrid working based on management discretion. Ability to travel off-site for audits, training, workshops and team meetings.