QA & Regulatory Affairs Associate – Medical Devices

Sculptmydream; Parsippany-Troy Hills (NJ); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with employer match (50%)

Discretionary bonus

Job summary

Canfield Imaging Systems in New Jersey seeks a Quality Assurance and Regulatory Affairs Associate to support audits, registrations, and documentation for medical devices. You will help maintain QA processes, ensure training documentation is complete, and assist with global regulatory submissions.

The role requires a Bachelor’s degree with 3+ years in QA/regulatory roles, ISO 13485 exposure, and strong communication. Canfield offers comprehensive benefits and a path to professional growth.

Qualifications

• Bachelor’s degree and at least 3+ years’ applicable work experience.
• 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.
• 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

ISO 13485

Regulatory affairs

Auditing

Communication

Project management

Education

Bachelor’s degree

Tools

MS Office

Job description

Canfield Imaging Systems in New Jersey seeks a Quality Assurance and Regulatory Affairs Associate to support audits, registrations, and documentation for medical devices. You will help maintain QA processes, ensure training documentation is complete, and assist with global regulatory submissions.

The role requires a Bachelor’s degree with 3+ years in QA/regulatory roles, ISO 13485 exposure, and strong communication. Canfield offers comprehensive benefits and a path to professional growth.