Quality Assurance: Quality Assurance and Regulatory Affairs Associate Parsippany, NJ

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

The Quality Assurance and Regulatory Affairs Lead is responsible for assisting the Quality Assurance team with day-to-day activities in support of company wide 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 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 company wide

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, red actions, 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

Maintain department calendar, including meeting scheduling and providing meeting minutes

Core Requirements:

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

Desired Requirements:

Photography knowledge/background is advantageous

Knowledge of European, Canadian, US Medical Device Regulatory Practices Canfield 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 Here Please submit resumes with cover letter to  or click below for immediate consideration. Please include the position title in the subject line.

We are proud to be an equal opportunity employer.