113 applicants

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Company

Original Job Post

FDA · 1 week ago

Operations Research Analyst

United States

Full-time

Remote

Senior Level

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Responsibilities

Provide expert direction to Center staff and leadership to ensure effective, efficient, and optimal utilization of resources.

Lead studies, analyses, and programs to facilitate the development and delivery of strategies, processes, and procedures necessary for implementing Congressional mandates and strategic initiatives.

Act as an improvement expert in medical device technical, regulatory, and administrative processes, providing advice to FDA centers, the Agency, and private industry.

Serve as an agency authority on applying quality management and organizational excellence methodologies to technical and regulatory processes.

Collaborate with engineers and healthcare professionals on process improvement projects and act as a focal point for identifying and resolving quality and organizational challenges.

Provide advice and consultations on quality, organizational excellence, and process improvement issues to CDRH leadership and other key agency officials.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Medical device knowledgeRegulatory processesProcess improvementStrategic planningQuality managementOrganizational excellenceProject managementCommunicationLeadershipCollaboration

Required

Expert knowledge of medical device technical, regulatory, and administrative processes and procedures

Experience in providing expert advice and consultation on improvement and implementation of processes and procedures

Ability to lead studies, analyses programs, and provide expert quality, process improvement, and organizational excellence support

Experience in developing strategies, processes, and procedures necessary for the implementation of Congressional mandates and strategic initiatives

Knowledge of quality management and organizational excellence methodologies

Ability to collaborate with engineers, medical professionals, and healthcare professionals on regulatory and policy processes improvement projects

Strong communication skills to articulate, explain, and defend initiatives and goals

Experience in developing recommendations and providing advice on quality, organizational excellence, and process improvement issues

Leadership skills to engage in strategic planning on resource issues and provide guidance to professionals

Ability to lead and represent the center on task forces, planning groups, or special study groups

Company

FDA

Glassdoor

4.1

The Food and Drug Administration is an agency within the Department of Health and Human Services.

Founded in 1906

Silver Spring, Maryland, USA

10,001+ employees

http://www.fda.gov

H1B Sponsorship

FDA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (49)

2022 (58)

2021 (51)

2020 (73)