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Keywords: Regulatory Affairs Specialist I,II, III, Location: USA

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Regulatory Affairs Specialist I,II, III

: TRI | Regulatory Support Department's Website: Summary of Job Duties: The Regulatory Affairs Specialist is directly.../development, regulatory start-up, regulatory maintenance and reporting from study activation to closeout. Level III: Bachelor...

Location: USA
Posted Date: 12 Feb 2025

Regulatory Affairs Specialist II

Specialist I & III for certain compliance critical tasks as required. The Regulatory Affairs Specialist II is responsible...About the job Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist II will be primarily...

Company: Fagron
Location: Decatur, AL
Posted Date: 22 Jan 2025

Regulatory Affairs Specialist

Regulatory Affairs Specialist Responsibilities: Determine and document change assessments for US Class II devices... to ensure compliance with the US regulation. Plan and prepare submissions for US Class II devices, including creating...

Company: Infraredx
Location: Bedford, MA
Posted Date: 12 Feb 2025

Regulatory Affairs Specialist

Regulatory Affairs Specialist Responsibilities: Determine and document change assessments for US Class II devices... to ensure compliance with the US regulation. Plan and prepare submissions for US Class II devices, including creating...

Company: Infraredx
Location: Bedford, MA
Posted Date: 12 Feb 2025

Senior Regulatory Affairs Specialist

& Responsibilities The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce.... Experience working with Class II and/ III medical devices (510(k), PMA, IDE, EU MDR) Skills and Knowledge Must demonstrate...

Company: Nevro Corp.
Location: Redwood City, CA
Posted Date: 12 Feb 2025
Salary: $123897 - 154871 per year

Senior Regulatory Affairs Specialist

& Responsibilities: The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce.... Experience working with Class II and/ III medical devices (510(k), PMA, IDE, EU MDR) Skills and Knowledge: Must demonstrate...

Company: Nevro Corp.
Location: Redwood City, CA
Posted Date: 12 Feb 2025
Salary: $123897 - 154871 per year

Sr Regulatory Affairs Specialist (Advertising and Promotion, Global) - Shockwave Medical

Johnson & Johnson is hiring for a Senior Regulatory Affairs Specialist (Advertising and Promotion, Global) - Shockwave... pressure waves for the treatment of calcified plaque. Position Overview The Senior Regulatory Affairs Specialist...

Location: Santa Clara, CA
Posted Date: 11 Feb 2025
Salary: $89000 - 143750 per year

Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)

. Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience... system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors...

Company: Amazon
Location: Sunnyvale, CA
Posted Date: 08 Feb 2025
Salary: $133900 per year

Senior Regulatory Affairs Specialists

Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Responsible for developing regulatory strategies, preparing... for Class I, II and III devices. Support Market Expansion and product development teams by preparing regulatory strategies...

Company: Medtronic
Location: Minneapolis, MN
Posted Date: 04 Feb 2025
Salary: $114400 - 133200 per year

Principal Regulatory Affairs Specialist – US New Product Introduction – Diabetes Care (on-site)

’ experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC... with our new sensing technology. The Opportunity The Principal RA Specialist – US New Product Introduction will work on-site...

Company: Abbott
Location: Alameda, CA
Posted Date: 03 Feb 2025
Salary: $98000 - 196000 per year

Principal Regulatory Affairs Specialist – Heart Failure (on-site)

’ experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus. Experience..., and scientists The Opportunity We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Heart Failure Division...

Company: Abbott
Location: Pleasanton, CA
Posted Date: 03 Feb 2025
Salary: $98000 - 196000 per year

Senior Regulatory Affairs Specialist (on-site)

Opportunity Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site... Advanced level degree Class II or Class III medical device experience Experience with PMA supplements, 510(k) applications...

Company: Abbott
Location: Plymouth, MN
Posted Date: 03 Feb 2025
Salary: $75300 - 150700 per year

Regulatory Affairs Specialist (REMOTE)

Regulatory Affairs Specialist is responsible for directing activities to ensure compliance with local regulations for software... and maintains relationships with external partners, regulators and opinion formers. What Will You Do: As a Regulatory Affairs...

Company: Haemonetics
Location: Massachusetts
Posted Date: 31 Jan 2025
Salary: $64906 - 87707 per year

Principal Regulatory Affairs Specialist – Heart Failure (on-site)

’ experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus. Experience..., and scientists The Opportunity We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Heart Failure Division...

Company: Abbott
Location: Pleasanton, CA
Posted Date: 06 Dec 2024
Salary: $95500 - 190900 per year

Senior Regulatory Affairs Specialist (on-site)

Opportunity Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site... Advanced level degree Class II or Class III medical device experience Experience with PMA supplements, 510(k) applications...

Company: Abbott
Location: Plymouth, MN
Posted Date: 20 Nov 2024
Salary: $72700 - 145300 per year

Senior Specialist, Regulatory Affairs

difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative... but not limited to providing regulatory expertise in US PMA Class III products, EU MDR, and working on product lifecycle management...

Location: Irvine, CA
Posted Date: 24 Jan 2025
Salary: $105000 - 124000 per year

Quality Assurance Specialist II-III (Analytical)

Therapeutics commercializes IBSRELA in Canada. Purpose of the role The QA Specialist II-III will be responsible for analytical..., etc.) Liaise with Regulatory Affairs on any manufacturing process/method/specification changes that may impact regulatory filings...

Company: Ardelyx
Location: Fremont, CA
Posted Date: 08 Dec 2024
Salary: $91217 - 101352 per year

Principal Regulatory Specialist

necessary technical documentation for US, Canada, and EU submissions. This position will be the Regulatory Affairs leader... access and sustaining support. Prepare and submit all aspects of Class II/Class III medical device applications for US FDA...

Posted Date: 22 Nov 2024

Clinical Research Specialist

to apply! Non-Nursing Levels: Clinical Research Specialist I Clinical Research Specialist II Clinical Research Specialist III... of Clinical Research Associates (SOCRA), Regulatory Affairs Professionals Society (RAPS) or Public Responsibility in Medicine...

Company: Novant Health
Location: Winston-Salem, NC
Posted Date: 07 Feb 2025

Pharmacy Prior Authorization Specialist

of advanced care with a 772-bed acute care hospital and the region’s only: Level II Trauma Center Joint Commission... Comprehensive Stroke Center Level III Neonatal Intensive Care Pediatric Intensive Care The most advanced cancer, heart...

Posted Date: 03 Feb 2025