Quality and Regulatory Manager (Hackensack, NJ)

Cedent; Hackensack (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

A medical device company in Hackensack, NJ is seeking a Quality and Regulatory Manager to oversee the management of Quality and Regulatory systems. The ideal candidate will possess over 5 years of experience in Quality Assurance or Regulatory Affairs within a regulated life sciences setting. This role involves ensuring compliance with regulations, managing daily QA activities, and supporting audits. Strong independent working skills and technical proficiency are essential for success in this position.

Qualifications

• 5+ years experience in Quality Assurance and/or Regulatory Affairs in a Medical Device or Human Tissue company.
• Ability to develop and manage Quality/Regulatory systems with minimal oversight.
• Working knowledge of 21CFR820 and ISO13485:2016.

Responsibilities

• Manage daily QA and Regulatory activities including Change Control and Document Control.
• Ensure timely documentation and execution of quality records.
• Support regulatory audits and customer audits.

Skills

Independent work

Cognitive abilities

Time management

Project management

Technical proficiency

Tools

Electronic Quality Management Systems

Job description

Quality and Regulatory Manager (Hackensack, NJ)

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