dt~4mo ago

Quality and Regulatory Manager (Hackensack, NJ)

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OtherRegulatory Manager

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Quick Summary

Overview

function googleTranslateElementInit() { new google.translate.TranslateElement({pageLanguage: 'en'}, 'google_translate_element'); } Quality and Regulatory Manager (Hackensack, NJ)…

Key Responsibilities

Manage and execute daily QA and Regulatory activities including Change Control, Document Control, Deviations/Non-Conformances, CAPAs, Supplier Management Ensure the timely documentation, execution, and completion of quality records Support…

Requirements Summary

3+ years of relevant work experience Experience within Quality and Regulatory in a regulated life sciences company (Medical Device, Biologics, Pharmaceutical, or Human Tissue) Ability to work independently Effective time and project management…

Technical Tools

project-management

The client is in search of a Quality and Regulatory Manager to join our growing team, responsible for the management and execution of day to day Quality and Regulatory systems. This position is a critical team member and will work collaboratively to ensure patient safety, product effectiveness, and quality/regulatory compliance.

IDEAL CANDIDATE:
The ideal candidate can work independently, has strong cognitive abilities, and 5+ years experience in Quality Assurance and/or Regulatory Affairs in a Medical Device or Human Tissue company. They must be able to own, develop, and manage Quality/Regulatory systems with minimal oversight and must have working knowledge of 21CFR820 and ISO13485:2016, Working knowledge of 21CFR1271 and the AATB Standards of Tissue Banking is a plus.

KEY RESPONSIBILITIES:

Manage and execute daily QA and Regulatory activities including Change Control, Document Control, Deviations/Non-Conformances, CAPAs, Supplier Management
Ensure the timely documentation, execution, and completion of quality records
Support regulatory (FDA, ISO) and customer audits
Support ongoing and new projects from a Quality/Regulatory perspective
Provide record review and Quality release of Sterilization and Finished Goods
Manage renewal of Regulatory registrations and licensing

REQUIREMENTS:

3+ years of relevant work experience
Experience within Quality and Regulatory in a regulated life sciences company (Medical Device, Biologics, Pharmaceutical, or Human Tissue)
Ability to work independently
Effective time and project management skills
Technically proficient
Experience working in electronic Quality Management Systems
Ability to support supplier audits a plus

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