Quality Assurance: Quality Assurance and Regulatory Affairs Associate Parsippany, NJ, United States Apply Now

The Quality Assurance and Regulatory Affairs Lead is responsible for assisting the Quality Assurance team with day-to-day activities in support of companywide quality assurance procedures. The right candidate will have excellent written/verbal communication skills, strong attention to detail, and work well in fast paced environment.Job Description: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 employeesDevelop and edit quality assurance documentation keeping it current ensuring consistent use of internal document standards/templates for key documents within the organizationObtain certificates of free sale from the FDA for the international marketsSupport 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 devicesResponsible for monitoring and generating monthly quality management system training objectives as well as gathering objectives from various departments companywideAct as a member of medical device quality councilMonitor changes to applicable regulations and report to quality assurance teamContribute to development of WIGs and other documents, redactions, and the administration of the training system softwareDistribute onboarding training to new employeesPrepare PowerPoint presentations for regulatory and quality assurance trainingsComplete clerical duties including filing/scanning/copying of validation documents, training records, and departmental documentationMaintain department calendar, including meeting scheduling and providing meeting minutesCore Requirements:Bachelor’s degree and at least 3+ years’ applicable work experienceExposure/experience with ISO 13485 and other international standardsAudit experience and ability to manage an auditor independentlyStrong communication and organizational skills, both verbal and written, to communicate on a large scale professionallyProficiency in Microsoft OfficeAbility to exercise sound judgment and make decisions independentlyDemonstrated project management experience for the full project life cycleKnowledgeable of GCP/ICH/regulatory practicesDesired Requirements:Photography knowledge/background is advantageousKnowledge of European, Canadian, US Medical Device Regulatory PracticesCanfield Imaging Systems is the world-leading developer of specialized photographic systems for medical practices, institutions, research organizations, and pharmaceutical suppliers. Canfield offers comprehensive benefits to its eligible full-time employees. These include paid days off, medical, dental, and vision insurance, may be eligible for a discretionary bonus, and a 401(k) plan with employer match (currently set at 50%). The anticipated salary range for the position is $. This is dependent upon consideration of multiple factors when determining a base salary such as a candidate’s experience, education, and current market conditions. If the role is eligible for full benefits, it will be discussed with you during the interview process. Canfield Imaging Systems is a division of Canfield Scientific, Inc., the largest provider of photographic documentation systems and services for pharmaceutical research. Apply HerePlease submit resumes with cover letter to View email address on click.appcast.io or click below for immediate consideration. Please include the position title in the subject line.We are proud to be an equal opportunity employer.