Post Market Specialist

Nova Biomedical • Billerica, MA

231d

About The Position

Nova Biomedical is looking for a Post Market Specialist. In this role, you will work as part of a collaborative team, to maintaining the Complaint Handling database to assure Nova Biomedical compliance to applicable regulations and requirements.

Requirements

• BS Degree, with a minimum of three years' experience within the medical device or diagnostic industry, or High School diploma or equivalent with 5+ years of experience within the medical device/diagnostic industry focused in complaint handling and/or customer support.
• A minimum of three years of post-market/complaint handling experience within a medical device or diagnostic market is required, including having previous responsibility to submit Medical Device Reports (MDRs) and/or adverse events to regulatory agencies.
• Knowledge of ISO/FDA QSR, experience with auditing, statistics, and database management.

Nice To Haves

• FDA QSR, MDSAP and ISO 13485 knowledge.
• Complaint Handling and MDR/Adverse Event Reporting.
• CAPA experience.
• Good writing skills.
• Demonstrate problem solving and trouble shooting skills.
• Microsoft Office (Word, Excel, PowerPoint).

Responsibilities

• Support investigations.
• Updates complaints reporting databases.
• Works with Field Personnel to resolve customer complaints in a timely fashion.
• Generates investigations and CAPAs and collaborate with complaint investigations as necessary.
• Reports issues to supervisor/manager to ensure timely resolution to customer complaints.
• Drafts MDRs and other reports as required to various Regulatory Agencies.
• Close complaints per Nova requirements.

Benefits

• Blue Cross Blue Shield medical plan
• tuition reimbursement
• matching 401K
• company subsidized cafeteria
• innovative scholarship program for children of employees

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree