Medical Device QA & Regulatory Affairs Specialist

Canfieldresearchgroup; Parsippany-Troy Hills (NJ); Vor Ort; USD 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401(k) with employer match

Zusammenfassung

Canfield Imaging Systems, Parsippany, NJ, is seeking a Quality Assurance and Regulatory Affairs Associate to support day‑to‑day QA activities and global certification efforts. You will help maintain documentation, assist with audits, and coordinate training records for employees.

You will work under the Senior QARA Manager to ensure regulatory compliance, contribute to process improvements, and help prepare regulatory submissions for medical devices.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Audit experience

ISO 13485

Regulatory practices

MS Office

Communication

Project management

Ausbildung

Bachelor’s degree

Tools

Microsoft Office

Jobbeschreibung

Canfield Imaging Systems, Parsippany, NJ, is seeking a Quality Assurance and Regulatory Affairs Associate to support day‑to‑day QA activities and global certification efforts. You will help maintain documentation, assist with audits, and coordinate training records for employees.

You will work under the Senior QARA Manager to ensure regulatory compliance, contribute to process improvements, and help prepare regulatory submissions for medical devices.