We are expanding our Quality Assurance/Regulatory Team and are actively looking for a Quality/Regulatory Specialist. Start your career with The Prometheus Group® and apply today!

QUALITY/REGULATORY SPECIALIST (MEDICAL DEVICE)

Annual Salary: $50,000 to $65,000 (DOE)

About Our Company:

We are a Service-Disabled Veteran Owned Small Business headquartered in Dover, New Hampshire, with over 30 years of experience specializing in the design, development, manufacture, and sales of diagnostic and rehabilitative medical devices.

Supervision Received:

• Individual reports to the Operations Manager

Essential Duties and Responsibilities:

• Assist the Operations Manager to ensure that medical devices are in compliance with applicable regulatory requirements and quality standards from the concept stage through the post-market stage.
• Assist the Operations Manager with the following:
  • Verification and Validation Activities
  • Risk Management
  • Design Control Activities (including change control for products and documents)
  • Registration of products with foreign countries
  • Preparation for Regulatory Audits

Required Qualifications:

• Familiarity with IEC 60601 Standards
• Familiarity with FDA Requirements for Medical Devices
• Familiarity with ISO 13485:2016 Standard
• Must have outstanding communication skills (verbal and written)
• Must be an outstanding team member
• Must be able to multitask
• Must be able to work with outside Engineering and Regulatory consultants

Other Helpful Qualifications:

• Experience with the Medical Device Single Audit Program (MDSAP) and familiar with regulations of participating countries
• Experience with UDI Requirements
• Experience working in a high energy, fast paced environment
• Experience working in a small business

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8-hour shift
• Monday to Friday

Work Location: One location

To Apply

Please send your cover letter and resume to: