Quality and Regulatory Manager (Hackensack, NJ)
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
- 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
Recommended Jobs
UX Designer with Dynamics CRM Developer
JOB DESCRIPTION : Ux Designer Microsoft Dynamics 365 CE/CRM Developer Position Overview: As a UX Designer for the Copilot product, you will play a critical role in shaping the user experience b…
M107-Project Manager/Business Analyst 775481
This job is hybrid in Newark, NJ In person interview is required. Our direct client has an opening for Project Manager/Business Analyst 775481 This position is for 11 months, w…
UVSO Pre-School Teacher
Pre School Teacher Job Description Update.docx ( View PDF For Detailed Job Description ) Organization: Unified Vailsburg Services OrganizationLocation: West Ward, Newark Unified Vailsburg Se…
Server
Job Overview Server Job Description We are looking for a Server for a casual American Bar concept located at our sister concept Apéro Steakhouse. You’ll be the face of our restaurant and responsible…
Vehicle Installation Technician
Make a Real Impact with East Coast Emergency LLC /LEHR Upfitters! East Coast Emergency LLC, a LEHR Company, has been a leader in the emergency vehicle industry for over 25 years. We’re a fast-grow…
Maintenance Technician
Job Description Job Description Job Summary: Under the direction of the Service Director and Real Estate Manager, the Service Technician is responsible for performing general maintenance, grou…
Airport Vending Services Associate
Merchandiser – JFK Airport Pay: $20.50/hr + Monthly Bonus (up to $150) + $50 Monthly Phone Credit / Weekly Pay Cycle Hours: Part-Time, 5:30 AM – 12:30 PM, 4–5 shifts per week (including weeken…
Drafter Manager
Summary The Drafting Manager will work alongside The President and Project Managers to help Prepare Clear and Concise Shop Drawings from The Drafters for The Field Installers. The Drafting Manager…
Chief of Staff
Spark Car Wash Overview Spark Car Wash is a high growth, institutionally backed express exterior car wash company serving the Northeast. Spark is growing fast and plans to open a significant numbe…