Quality Assurance and Regulatory Affairs Associate
Canfield Scientific, Inc.
- Parsippany-Troy Hills, NJ
- 18 days ago
Highlights
The Quality Assurance and Regulatory Affairs Lead is responsible for assisting the Quality Assurance team with day-to-day activities in support of companywide quality assurance procedures. The right candidate will have excellent written/verbal communication skills, strong attention to detail, and work well in fast paced environment.
Numbers & Facts
| Location | Parsippany-Troy Hills, NJ |
| Job Type | Full-time |
Description
The Quality Assurance and Regulatory Affairs Lead is responsible for assisting the Quality Assurance team with day-to-day activities in support of companywide quality assurance procedures. The right candidate will have excellent written/verbal communication skills, strong attention to detail, and work well in fast paced environment.
Job Responsibilities
Job Description:
- Support the compilation, organization, maintenance of medical device product documentation, device registrations, maintaining current registration lists, and reporting registration status updates to stakeholders
- Assist with distributor change management
- Support supplier requalification activities and the management of supplier agreements
- Compile regulatory listings and market requirements for existing and upcoming markets
- Support usability engineering activities, proctoring usability exercises, and assisting with related documentation
- Support design reviews and distributing draft documents to subject matter experts for review
- Provide audit support by managing document requests and assisting with administrative preparation
- Monitor applicable regulatory changes and assist in communicating relevant updates to team members
- Draft engineering change order forms and document change order forms
- Maintain the document change log and design and development file index
- Prepare meeting minutes and support the development of management review materials
- Support validation activities for production software, off-shelf software, and product testing software
- Provide production quality oversight, including ESD wrist strap and bench testing records, Certificate of Compliance management, supplier onboarding forms, nonconforming product forms, and production training documentation
- Maintain the production training matrix and communicate training assignments/completion status
- Manage the QA schedule, track deliverables, set reminders, and administrative tasks
Qualifications
Core Requirements:
- Bachelor’s degree or at least 2 years applicable work experience preferred in quality assurance, regulatory affairs, medical devices, pharmaceuticals, or experience in another regulated industry
- Professional demeanor with excellent written and verbal communication skills, strong organizational skills, and effective coordination skills
- Proficient with Microsoft Office
- Knowledgeable of the regulatory process (FDA, ISO, cGMP)
Desired Requirements:
- Photography knowledge/background is advantageous
About Company
Canfield Imaging Systems is the world-leading developer of specialized photographic systems for medical practices, institutions, research organizations, and pharmaceutical suppliers. Canfield offers comprehensive benefits to its eligible full-time employees. These include paid days off, medical, dental, and vision insurance, may be eligible for a discretionary bonus, and a 401(k) plan with employer match (currently set at 50%). The anticipated salary range for the position is $26.00-$30.00 per hour. This is dependent upon consideration of multiple factors when determining a base salary such as a candidate’s experience, education, and current market conditions. If the role is eligible for full benefits, it will be discussed with you during the interview process. Canfield Imaging Systems is a division of Canfield Scientific, Inc., the largest provider of photographic documentation systems and services for pharmaceutical research.