Global Medical Devices QA & Regulatory Associate

Canfield; Parsippany-Troy Hills (NJ); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Paid days off

Medical insurance

Dental insurance

Vision insurance

Discretionary bonus

401(k) match

Job summary

Canfield Imaging Systems in Parsippany, NJ seeks a Quality Assurance and Regulatory Affairs Associate to support QA activities, audits, and documentation in a fast-paced medical device setting.

You will help maintain ISO 13485 compliance, assist with regulatory filings for global markets, and develop QA materials and training deliverables for staff, collaborating with cross-functional teams.

Qualifications

• Bachelor’s degree and at least 3+ years of 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.
• Proficiency in Microsoft Office and project management experience.

Responsibilities

• Assist QA team with day-to-day activities supporting QA procedures.
• Audit support and regulatory registrations with oversight from Senior QARA Manager.
• Develop and edit QA documentation ensuring templates are current.
• Obtain certificates of free sale from the FDA for international markets.
• Support production processes including validation efforts for product/software.
• Monitor and report training objectives and onboarding for staff.
• Contribute to development of training materials and regulatory documents.
• Prepare regulatory and quality assurance trainings and presentations.
• Complete clerical duties including filing/scanning/copying validation documents.

Skills

Verbal and written communication

Audit experience

Project management

MS Office proficiency

Regulatory knowledge (GCP/ICH)

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Canfield Imaging Systems in Parsippany, NJ seeks a Quality Assurance and Regulatory Affairs Associate to support QA activities, audits, and documentation in a fast-paced medical device setting.

You will help maintain ISO 13485 compliance, assist with regulatory filings for global markets, and develop QA materials and training deliverables for staff, collaborating with cross-functional teams.