Post Market Associate

Nova Biomedical Corporation • Waltham, MA

4d • Hybrid

About The Position

The Post Market Associate provides support to the Quality Assurance function by performing activities associated with customer product complaints, including receipt, evaluation, investigation, trending, reporting, and closure. This role also supports Post-Market Surveillance (PMS) activities and works closely with cross-functional teams to ensure compliance with quality system and regulatory requirements throughout the product lifecycle.

Requirements

• Knowledge of ISO 13485, MDSAP, and FDA Quality System Regulations required.
• Proficiency with Microsoft Office and Adobe applications.
• Experience working with eQMS and ERP systems.
• Strong written communication skills.
• Strong attention to detail.

Nice To Haves

• Experience with additional global regulatory requirements preferred.
• Experience with Salesforce.
• Experience with Power BI.
• Experience with in vitro diagnostics (IVD/IVDR) preferred.
• Minimum of 3 years of related experience and/or training preferred.
• Bachelor�s degree in a scientific or technical discipline.
• Quality and/or Regulatory certifications are a plus.

Responsibilities

• Own complaint and post-market surveillance activities utilizing the Complaint Handling platform.
• Initiate complaint files and document complaint evaluations and regulatory reportability assessments within the Complaint Handling System in accordance with company procedures, GMPs, FDA regulations, ISO standards, and other applicable regulatory requirements.
• Make reportability determinations and submit Medical Device Reports (MDRs) as required.
• Conduct preliminary complaint investigations, including Device History Record reviews, shipment and lot history reviews, and complaint trending to support root cause analysis.
• Update complaint records to reflect investigation findings, perform risk assessments, assess corrective actions, and close complaint records.
• Provide support to cross-functional teams related to complaint management activities.
• Work with Field Personnel to resolve customer complaints in a timely manner.
• Support CAPA investigations, root cause determinations, and risk evaluations.
• Trend complaint root causes to identify opportunities for product and process improvement.
• Partner with Regulatory Affairs to document and implement Post-Market Surveillance plans for all product families.
• Execute PMS plans throughout the commercial lifecycle by collecting data, analyzing information, and completing PMS reports.
• Support controlled document management and quality records management activities.
• Participate in internal and external audits.
• Promote a culture of quality and compliance focused on customer needs and regulatory requirements.
• Perform other duties as assigned.

Benefits

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level