Job Title

Sr. Manager, Clinical Affairs

Location(s)

Turku

About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity

Position Summary

The Senior Manager, Clinical Affairs, Reproductive Health leads the planning and execution of clinical evidence generation activities supporting Revvity’s Reproductive Health portfolio. The role is based in Turku, Finland and provides hands-on leadership for laboratory-driven performance evaluation studies, sample acquisition activities, and clinical documentation supporting IVD product development and regulatory submissions.

RH clinical programs are primarily observational and laboratory-based, leveraging de-identified leftover specimens, including dried blood spots and residual clinical samples, sourced from public health laboratories, newborn screening programs, hospital laboratories, and biobanks. Studies typically focus on analytical and clinical performance, cut-off determination, usability, stability, and operational validation rather than interventional subject enrollment.

This role partners closely with RH R&D, Regulatory Affairs, Quality, Medical Affairs, Scientific Affairs, and commercial teams to ensure clinical evidence is scientifically robust, operationally efficient, inspection-ready, and aligned with global regulatory expectations.

Key Responsibilities Clinical Strategy and Planning

• Develop and execute RH clinical plans supporting new product introduction, lifecycle management, and regulatory submissions.
• Translate product requirements and regulatory needs into practical study designs, including sample strategy, specimen sourcing, operational feasibility, timelines, and resourcing.
• Ensure clinical evidence plans align with EU IVDR, FDA, and other applicable regulatory pathways.

Study Execution and Oversight

• Lead end-to-end execution of laboratory-based clinical performance evaluations, design validation studies, and sample acquisition activities.
• Oversee relationships with external laboratories, public health labs, biobanks, and service providers, ensuring quality, compliance, timelines, and budget adherence.
• Ensure consistent application of protocols, deviation management, training documentation, monitoring readiness, and archival practices.
• Maintain inspection-ready documentation and structured study files aligned with Revvity quality systems.

Governance, Compliance, and Quality Partnership

• Ensure studies meet applicable ethical, privacy, and regulatory expectations for use of de-identified residual specimens.
• Partner with Quality, Regulatory, Legal, and Compliance to ensure appropriate contracting, documentation, and governance models are consistently applied.
• Drive clarity of roles, decision rights, and operating discipline across RH clinical activities.

Team Leadership and Capability Building

• Directly manage and develop RH Clinical Affairs staff, including workload planning, coaching, performance management, and capability development.
• Establish consistent operating rhythms for execution reviews, risk tracking, and cross-functional coordination.
• Build scalable processes that support program growth while maintaining quality and efficiency.

Cross-Functional Leadership and Communication

• Serve as the primary RH Clinical Affairs point of contact for cross-functional program teams.
• Deliver clear executive-ready updates on progress, risks, mitigation plans, and resource needs.
• Support audits, inspections, and regulatory interactions as required.

Success Measures (First 12 Months)

• On-time delivery of RH clinical milestones and study outputs.
• Consistent inspection-ready documentation and file quality across RH studies.
• Improved predictability and efficiency in specimen sourcing and laboratory execution.
• Clear governance and role clarity across RH clinical activities.
• Balanced workload, engagement, and development of direct reports.

Required Qualifications

• Bachelor’s degree in life sciences, engineering, clinical science, or related discipline. Advanced degree preferred.
• Demonstrated experience in clinical affairs, clinical operations, laboratory validation, or clinical evidence generation within diagnostics, IVD, Med Tech, or regulated laboratory environments.
• Working knowledge of GCP principles and documentation expectations appropriate for IVD clinical evidence.
• Experience managing vendors, timelines, budgets, and cross-functional stakeholders.
• Proven people leadership capability with direct report management experience.
• Strong written and verbal communication skills with the ability to produce clear, executive-ready documentation and presentations.
• Fluency in written and spoken English is required for business communication, documentation, and cross-functional collaboration in a global environment.

Preferred Qualifications

• Experience working with public health laboratories, newborn screening programs, population screening environments, or government-affiliated laboratories.
• Familiarity with DBS workflows, residual specimen studies, biobank sourcing, sample stability evaluations, and laboratory QC practices.
• Experience supporting EU IVDR aligned clinical evidence planning and regulatory submissions.
• Background in reproductive health, prenatal screening, newborn screening, or population health diagnostics.
• Demonstrated success building standardized processes and scalable operating models.

Travel

Occasional travel within Europe and periodic travel to the United States as required.