Quality Assurance and Regulatory Affairs Lead
Canfield Scientific, Inc.
- Parsippany-Troy Hills, NJ
- Today
Highlights
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.
Numbers & Facts
| Location | Parsippany-Troy Hills, NJ |
| Job Type | Full-time |
Description
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 Responsibilities
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 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
- Maintain department calendar, including meeting scheduling and providing meeting minutes
Qualifications
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
About Company
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.