QA & Regulatory Affairs Associate — Med Devices

Canfield Scientific, Inc.; Parsippany-Troy Hills (NJ); On-site; USD 70,000 - 100,000; Full time

Job summary

Canfield Scientific, Inc. is seeking a Quality Assurance and Regulatory Affairs Associate to support day-to-day QA activities and regulatory submissions. The role requires strong written and verbal communication, attention to detail, and the ability to work in a fast-paced environment.

Your responsibilities include audits, ISO 13485-related tasks, training administration, document control, and contributing to regulatory filings and compliance across global markets.

Qualifications

• Bachelor’s degree and at least 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.
• Proficiency in Microsoft Office.

Responsibilities

• Support QA audits and regulatory certifications; assist global medical device registrations.
• Develop and edit QA documentation and ensure templates are followed.
• Obtain FDA certificates of free sale for international markets.
• Oversee production process validations and design documentation.
• Monitor regulatory changes and report to QA team.
• Prepare QA trainings and related PowerPoint presentations.
• Complete clerical duties: filing, scanning, and training records.

Skills

Excellent written/verbal communication

Attention to detail

Strong organizational skills

Ability to work independently

Project management

GCP/ICH/regulatory practices knowledge

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Canfield Scientific, Inc. is seeking a Quality Assurance and Regulatory Affairs Associate to support day-to-day QA activities and regulatory submissions. The role requires strong written and verbal communication, attention to detail, and the ability to work in a fast-paced environment.

Your responsibilities include audits, ISO 13485-related tasks, training administration, document control, and contributing to regulatory filings and compliance across global markets.