Clinical Affairs Manager

JOB SUMMARY

Nordson Medical Surgical Solutions (Quest Medical) is seeking an experienced Clinical Affairs Manager to lead evidence generation for Quest's product portfolio, with primary focus on the Myocardial Protection System (MPS) used in cardiac surgery and perfusion workflows and Hemodialysis products (e.g., Lyka). This individual contributor will design and execute the clinical evidence strategy across prospective and retrospective studies, registries, and post-market activities to substantiate safety, performance, and clinical outcomes that support adoption, labeling, market access, and global regulatory requirements. The role will partner closely with R&D, Regulatory, Marketing, Quality, and external Key Opinion Leaders.

The position requires a strong working knowledge of ISO 14155 and Good Clinical Practice for medical devices, U.S. IDE requirements under 21 CFR Part 812, and EU MDR clinical evidence expectations, including PMCF and CER deliverables, as well as compliance with the Sunshine Act.

ESSENTIAL DUTIES & RESPONSIBILITIES

Evidence Strategy and Planning

• Own the multi-year Clinical Evidence Plan for MPS and related portfolio, mapping priority claims to required data and study designs.
• Define hypotheses, endpoints, sample size assumptions, comparators, and statistical analysis approach in partnership with biostatistics.
• Build an integrated publication and congress strategy aligned to study milestones and launch timelines.
• Ensure the plan addresses pre-market and post-market needs, including PMCF and real-world evidence.

Study Design and Execution

Post-Market Evidence, PMCF, and Clinical Evaluation

Compliance and Clinical Governance

Stakeholder and KOL Engagement

Dissemination and Medical Communications

EDUCATION & EXPERIENCE REQUIREMENTS

SKILLS & ABILITIES

WORKING CONDITIONS & PHYSICAL DEMANDS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Ability to be in the OR during cardiac procedures for observational purposes and training as permitted by site policies and applicable regulations.

The requirements listed above are representative of the knowledge, skill, and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

TRAVEL REQUIRED

None

Minimal

Estimated 20%-40% (including International)