QA & Regulatory Affairs Associate (Medical Devices)

Imagingexcellence; Parsippany-Troy Hills (NJ); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, vision insurance

Discretionary bonus

401(k) plan with employer match

Job summary

Canfield Imaging Systems, Parsippany, NJ, seeks a Quality Assurance and Regulatory Affairs Associate to support QA activities, audits, and regulatory submissions for medical devices. The role emphasizes documentation control, training administration, and collaboration with cross-functional teams.

The ideal candidate holds a Bachelor's degree with 3+ years of QA/Regulatory experience, familiarity with ISO 13485 and GCP/ICH practices, and strong communication skills.

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
• Ability to exercise sound judgment and make decisions independently
• Demonstrated project management experience for the full project life cycle
• Knowledgeable of GCP/ICH/regulatory practices

Responsibilities

• Support and act as a QA contact for regulatory and certification audits, support and facilitate global medical device registrations with oversight from Senior QARA Manager, aid in administration of the training system software to ensure timely and efficient documentation of training for all employees
• Develop and edit quality assurance documentation keeping it current ensuring consistent use of internal document standards/templates for key documents within the organization
• Obtain certificates of free sale from the FDA for the international markets
• Support and provide oversight on production processes such as: validation efforts for both product software and non-product software, improvement projects for commercial initiatives, and help develop design documentation for medical devices
• Responsible for monitoring and generating monthly quality management system training objectives as well as gathering objectives from various departments companywide
• Act as a member of medical device quality council
• Monitor changes to applicable regulations and report to quality assurance team
• Contribute to development of WIGs and other documents, redactions, and the administration of the training system software
• Distribute onboarding training to new employees
• Prepare PowerPoint presentations for regulatory and quality assurance trainings
• Complete clerical duties including filing/scanning/copying of validation documents, training records, and departmental documentation

Skills

QA documentation

Regulatory affairs

Audit management

Communication skills

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Canfield Imaging Systems, Parsippany, NJ, seeks a Quality Assurance and Regulatory Affairs Associate to support QA activities, audits, and regulatory submissions for medical devices. The role emphasizes documentation control, training administration, and collaboration with cross-functional teams.

The ideal candidate holds a Bachelor's degree with 3+ years of QA/Regulatory experience, familiarity with ISO 13485 and GCP/ICH practices, and strong communication skills.