Fda Jobs in Fall River, MA (NOW HIRING)

Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing ...

Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...

Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...

The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. In this role, you will lead the preparation, analysis, and submissions dossiers to various governing ...

The receiver/inspector is familiar with HACCP, SQF, and USDA/FDA guidelines and procedures and is responsible for the completion of all required paperwork and reporting procedures. What you'll do:

Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), including its incorporation of ISO 13485:2016 effective February 2026. * Strong applied ...

... knowledge in FDA QSR and ISO13485 requirements is preferred Minimum of 5 years of related experience Key Competencies Teaming and collaboration, including building strong cross-functional ...

Support FDA inspections and internal audits. Track commitments, findings, CAPAs, and remediation activities. Ensure all required REMS documentation is current and inspection-ready. * Vendor and ...

Support FDA inspections and internal audits.Track commitments, findings, CAPAs, and remediation activities.Ensure all required REMS documentation is current and inspection-ready. * Vendor and Partner ...

... FDA 21 CFR Part 820 (QSR). This role partners closely with R&D, Manufacturing, Regulatory Affairs, and Program Management to ensure design control compliance, effective risk management, and ...

Support internal and external audits (FDA, Notified Body, MDSAP) related to design controls. Act as SME for design quality systems during inspections. Analyze design-related quality metrics (e.g ...

Ensure compliance with FDA regulations and quality system requirements * Prepare technical reports, presentations, and manufacturing documentation * Support continuous improvement and process ...

The receiver/inspector is familiar with HACCP, SQF, and USDA/FDA guidelines and procedures and is responsible for the completion of all required paperwork and reporting procedures. What you'll do:

This role is critical in ensuring compliance with regulatory standards (FDA, ISO 13485, 21 CFR Part 820), working closely with engineering, QA, and manufacturing teams. Key Responsibilities:

The receiver/inspector is familiar with HACCP, SQF, and USDA/FDA guidelines and procedures and is responsible for the completion of all required paperwork and reporting procedures. What you'll do:

Knowledge and experience with GMP, ISO, FDA, and quality standards * Experience with manufacturing documentation such as, but not limited to, Bill of Materials (BOM), shop orders, routers, and other ...

The receiver/inspector is familiar with HACCP, SQF, and USDA/FDA guidelines and procedures and is responsible for the completion of all required paperwork and reporting procedures. What you'll do:

Develop and execute IQ/OQ/PQ validation protocols for thermoforming and sealing processes in compliance with ISO 11607-2 and FDA process validation guidance. * Define critical process parameters ...

Develop and execute IQ/OQ/PQ validation protocols for thermoforming and sealing processes in compliance with ISO 11607-2 and FDA process validation guidance. * Define critical process parameters ...

Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities. * Represent Quality initiatives and compliance when participating and Design and Phase reviews * Serve as an effective ...