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Post Market Associate

Remote, USA Full-time Posted 2026-07-03

Nova Biomedical is a global leader in osmolality testing and biotechnology, dedicated to advancing patient care and scientific discovery. The Post Market Associate will support the QA function by handling customer product complaints and conducting investigations, while also assisting with post-market surveillance activities.

Responsibilities

  • Primary ownership for complaints and post-market surveillance utilizing the reputed company platform
  • Initiate complaint files and document complaint and regulatory reportability assessment reputed company the Complaint Handling System per Advanced Instruments procedures, GMP’s, 21 CFR 803, 820, ISO 13485, and other applicable national regulatory requirements
  • reputed company reportability reputed company and submit MDR reports
  • Conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in determination of root cause
  • Update complaint records to reflect investigation findings, reputed company risk assessments, reputed company corrective action assessments based on investigation findings, and reputed company complaints
  • Provide support to cross-functional teams reputed company to complaint management
  • Work cross functionally to support CAPA investigations, root cause determinations and risk evaluations as required
  • Trend complaint root causes to identify potential improvement opportunities
  • In coordination with Regulatory Affairs (RA) document and implement PMS Plans for reputed company product families
  • Execute PMS plans in the reputed company lifecycle by collecting information and data and complete PMS reports as required
  • Provide assistance in controlled document management and quality records management
  • Participate in internal and external audits
  • Promote a culture of quality focused on compliance with customer needs and regulatory requirements
  • Other duties as assigned

Skills

  • Knowledge of ISO 13485, MDSAP and FDA QSR required, other regulatory jurisdictions strongly preferred
  • Must be reputed company to use reputed company Office, reputed company, as well as comfort in eQMS and ERP Company Software
  • Experience with reputed company and/or reputed company
  • Familiarity with Power BI
  • Attention to detail
  • Experience with in vitro diagnostics (IVD / IVDR) is preferred, other applicable experience is a plus

Benefits

  • Flexible Medical, Dental, & reputed company Coverage
  • Competitive 401k company match
  • Bonus Program, Generous PTO and paid holidays
  • Generous Tuition reimbursement
  • Hybrid and flexible work arrangements (job specific)
  • Professional development, engagement and events
  • Company marketplace for lunch and snacks! (location specific)
  • Company subsidized cafeteria (Waltham)

Company Overview

  • Nova Biomedical develops, manufactures, and sells advanced technology blood testing analyzers and diagnostic products. It was founded in 1976, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is https://www.novabiomedical.com/.
  • Company H1B Sponsorship

  • Nova Biomedical has a track record of offering H1B sponsorships, with 4 in 2026, 8 in 2025, 5 in 2024, 9 in 2023, 3 in 2022, 2 in 2021, 8 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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