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Clinical Affairs Manager

Clinical Affairs Manager

NordsonAllen, TX, US
[job_card.full_time]
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...[show_more][last_updated.last_updated_30]
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Public Safety Officer

Public Safety Officer

Government JobsAllen, TX, US
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Jump into a full-time role (40 hours / week) with the City of Allen and enjoy a benefits-package designed to support you both at work and in life! You'll get comprehensive medical, dental, and vision...[show_more][last_updated.last_updated_30]
Clinical Affairs Manager

Clinical Affairs Manager

Nordson CorporationAllen, Texas, USA
[job_card.full_time]
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...[show_more][last_updated.last_updated_30]
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Corporate Affairs Account Manager Lead, Content Studio

Corporate Affairs Account Manager Lead, Content Studio

USAA CareersAllen, Texas, US
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Ensure you read the information regarding this opportunity thoroughly before making an application.At USAA, our mission is to empower our members to achieve financial security through highly compet...[show_more][last_updated.last_updated_1_day]
Financial Aid / Veteran Affairs Advisor

Financial Aid / Veteran Affairs Advisor

Collin CollegeFrisco Campus
[job_card.full_time]
Wade Boulevard, Frisco, Texas, 75035.We are searching for candidates that meet the required qualifications and experience and are able to perform the essential duties and responsibilities.Advise an...[show_more][last_updated.last_updated_variable_days]
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Remote Bilingual Korean Government / Public Policy Expert - AI Trainer ($45-$60 per hour)

Remote Bilingual Korean Government / Public Policy Expert - AI Trainer ($45-$60 per hour)

MercorAllen, Texas, US
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[job_card.full_time]
Mercor is seeking • •native Korean speakers • • who are also • •government or public policy professionals • • based in • •Korea • •. This role combines your • •public policy expertise • • with • •language master...[show_more][last_updated.last_updated_variable_days]
PUBLIC INFORMATION OFFICER, Public Health

PUBLIC INFORMATION OFFICER, Public Health

Tarrant CountyTarrant County, TX
[job_card.full_time]
Perform professional level duties on a day-to-day basis to achieve the short-term goals of the work group.Assist with the coordination of the Public Health Department communications, public informa...[show_more][last_updated.last_updated_30]
Public Safety Officer

Public Safety Officer

City of AllenAllen, TX, United States
[job_card.permanent]
THIS POSTING MAY CLOSE AT ANY TIME ONCE A SUFFICIENT NUMBER OF APPLICATIONS HAVE BEEN RECEIVED.With over 100,000 residents, the City of Allen is a dynamic and welcoming community.The City of Allen'...[show_more][last_updated.last_updated_variable_days]
Public Safety Communications Specialist

Public Safety Communications Specialist

City of McKinneyMckinney, TX, United States
[job_card.full_time] +1
Public Safety Communications Specialist.City of McKinney Join to apply for the.Public Safety Communications Specialist.City of McKinney Get AI-powered advice on this job and more exclusive features...[show_more][last_updated.last_updated_1_day]
Customer Service - Self Storage Manager

Customer Service - Self Storage Manager

Public StorageMcKinney, TX, United States
[job_card.full_time]
Our Property Managers get to work independently at multiple locations; spending time both inside and outside.We assess customer storage needs and make suggestions, including selling packing and mov...[show_more][last_updated.last_updated_variable_days]
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Financial Aid / Veteran Affairs Specialist

Financial Aid / Veteran Affairs Specialist

InsideHigherEdFairview, Texas, United States
[job_card.full_time]
Spring Creek Parkway, Plano, Texas, 75074.We are searching for candidates that meet the required qualifications and experience and are able to perform the essential duties and responsibilities.Serv...[show_more][last_updated.last_updated_variable_days]
Clinical Affairs Manager

Clinical Affairs Manager

NordsonAllen, TX, US
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  • [job_card.full_time]
[job_card.job_description]

Clinical Affairs Manager

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

  • Author or co-author protocols, informed consents, investigator brochures, monitoring plans, and statistically relevant sections.
  • Lead site identification, feasibility, selection, startup, and training for cardiac surgery and perfusion centers.
  • Oversee execution of prospective clinical investigations and retrospective chart reviews, ensuring adherence to protocol, ISO 14155, GCP, and applicable regulations.
  • Manage vendors and CROs for monitoring, data management, imaging, and core lab services, track timelines, budgets, and risk mitigation actions.

    • Post-Market Evidence, PMCF, and Clinical Evaluation

  • Plan and deliver PMCF activities such as registries, surveys, targeted studies, and literature surveillance to meet EU MDR expectations.
  • Drive Clinical Evaluation deliverables by conducting systematic literature reviews, appraising clinical data, and contributing to the Clinical Evaluation Report (CER) in collaboration with Regulatory.
  • Translate post-market findings into labeling updates, risk management inputs, and value dossiers.

    • Compliance and Clinical Governance

  • Ensure studies comply with 21 CFR Part 812 for IDEs, human subject protections, safety reporting, and essential document controls.
  • Partner with sites on IRB / EC submissions, adverse event adjudication, and audit readiness.
  • Maintain inspection-ready Trial Master File and data integrity across EDC and source.
  • Compliance and governance of the Sunshine Act for the organization.

    • Stakeholder and KOL Engagement

  • Build productive relationships with cardiac surgeons, perfusionists, and clinical leaders; convene advisory boards and investigator meetings.
  • Serve as clinical voice for new product development and claims substantiation; review scientific content in promotional materials for fair balance and accuracy.

    • Dissemination and Medical Communications

  • Lead abstract, poster, podium, and manuscript development with investigators; ensure alignment to CONSORT or STROBE as appropriate.
  • Prepare clinical summaries for regulatory submissions, payer dossiers, and sales education.

    • Education & Experience Requirements

  • Bachelor's degree in Life Sciences, Biomedical Engineering, Nursing, or related field.
  • 8-12 years in medical device clinical affairs or clinical research with end-to-end ownership of device studies.
  • Demonstrated proficiency with ISO 14155, GCP, 21 CFR Part 812, and EU MDR clinical evidence requirements, including PMCF and CER, as well as the Sunshine Act.
  • Experience working directly with surgeons and perfusionists or within cardiac OR / CPB settings preferred.
  • Hands-on experience with protocol writing, site management, monitoring oversight, data review, and vendor / CRO leadership.
  • Strong scientific writing, presentation, and cross-functional communication skills.

    • Skills & Abilities

  • Strategic planning for evidence generation and claims enablement.
  • Project management across complex, multi-site programs with schedule, budget, and quality ownership.
  • Risk identification and mitigation, problem solving, and inspection readiness.
  • Influence without authority and effective KOL engagement.
  • Scientific storytelling and publication planning.

    • 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)