Medical Devices QA & Regulatory Associate

Canfield; Parsippany-Troy Hills (NJ); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k) match 50%

Job summary

Canfield Imaging Systems in Parsippany, NJ is seeking a Quality Assurance: Quality Assurance and Regulatory Affairs Associate to support QA and regulatory activities in a fast-paced medical device environment. The role focuses on audits, regulatory registrations, documentation, and training; requires ISO 13485 exposure, 3+ years experience, and strong communication.

You will develop QA documentation, monitor training objectives, and assist in regulatory submissions, with opportunities for growth

Qualifications

• Bachelor’s degree and 3+ years’ applicable work experience
• Exposure/experience with ISO 13485 and other international standards
• Audit experience and ability to manage an auditor independently
• Strong communication and organizational skills, both verbal and written, to communicate on a large scale professionally

Responsibilities

• Support regulatory audits and coordinate certifications internationally.
• Assist with FDA registrations and maintain training documentation.
• Develop, edit, and standardize QA documents and templates.
• Oversee production validation and design documentation for medical devices.
• Monitor and report training objectives across departments.
• Act as a member of the quality council and support regulatory initiatives.

Skills

ISO 13485

Audit experience

Communication skills

Microsoft Office

Independent decision making

Project management

GCP/ICH/regulatory practices

Education

Bachelor’s degree

Job description

Canfield Imaging Systems in Parsippany, NJ is seeking a Quality Assurance: Quality Assurance and Regulatory Affairs Associate to support QA and regulatory activities in a fast-paced medical device environment. The role focuses on audits, regulatory registrations, documentation, and training; requires ISO 13485 exposure, 3+ years experience, and strong communication.

You will develop QA documentation, monitor training objectives, and assist in regulatory submissions, with opportunities for growth