Regulatory Affair Specialist jobs in Marlborough, MA

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MANAGER QUALITY ASSURANCE AND REGULATORY AFFAIRS, LABORATORY SERVICE

Directly manage QA Lab Support personnel. Lead the Quality Assurance processes for Clinical Research Services (CRS). Help implement and maintain quality/regulatory aspects of CLIA, GLP and ICH-GCP. Ensure CRS team is up to date on...

CompanyAkoya Biosciences
AddressMarlborough, MA
CategoryManufacturing
Salary$130,000 - $150,000 a year
Job typeFull-time
Date Posted 2 months ago See detail

Manager Quality Assurance and Regulatory Affairs, Laboratory Service

Akoya Biosciences

Marlborough, MA

$130,000 - $150,000 a year

Directly manage QA Lab Support personnel. Lead the Quality Assurance processes for Clinical Research Services (CRS). Help implement and maintain quality/regulatory aspects of CLIA, GLP and ICH-GCP. Ensure CRS team is up to date on...

SVP, Global Regulatory Affairs

Biospace

Waltham, MA

Ensure the development, preparation, and implementation of global strategic regulatory plan for all programs and product pipeline designed to maximize successful and expedient global product registrations. Responsible for managing...

Director, Regulatory Affairs

Biospace

Waltham, MA

Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings. As a member of program teams, provide global regulatory guidance regarding requirements for clinical development a...

Remote - Sr. Regulatory Affairs Associate - Pharmaceuticals

Fresenius Medical Care

Waltham, MA

Provides regulatory assessment and support. Evaluates and assesses regulatory impact of proposed product changes. Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development team...

Remote - Regulatory Affairs Associate II Pharma

Fresenius Medical Care

Waltham, MA

$87.1K - $110K a year

Provides regulatory assessment and support. Evaluates and assesses regulatory impact of proposed product changes. Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development team...

Regulatory Affairs Manager

Pramand Llc

Bedford, MA

$97.2K - $123K a year

Regulatory Strategy Formulate and execute regulatory strategies to assure timely and successful product approvals. Provide regulatory guidance to crossfunctional teams to support product development and commercialization. Regula...

Regulatory Affairs Sr Manager (Medical Device)

Connexion Systems & Engineering, Inc.

Westford, MA

Responsible for the oversight of Regulatory Affairs as directed. Plans, analyzes, and prepares regulatory submissions for FDA and may support other international agencies as necessary. Manages the collection and coordination of in...