Strategic Quality & Regulatory Manager — Medical Devices

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

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.