Post Market Associate

Nova Biomedical Corporation • Norwood, MA

2d • $55,000 - $63,000 • Hybrid

About The Position

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical , marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets. About the company At Nova Biomedical, were not just building instruments, were powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care. Our integration brings together more than 70 years of scientific excellence with Novas cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, were setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences. With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, were building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity . Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, youll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health. Explore whats next with us at novabiomedical.com About the role The Post Market Associate provides support to the QA function by performing activities associated with customer product complaints, including receipt, evaluation, investigation, trending, reporting, and closure. They also provide support for other functions such as Post-market Surveillance (PMS). If youre passionate about Post market activities and want to be part of a team that is shaping the future of life sciences, wed love to hear from you, apply today!

Requirements

• Knowledge of ISO 13485, MDSAP and FDA QSR required, other regulatory jurisdictions strongly preferred.
• Must be able to use Microsoft Office, Adobe, as well as comfort in eQMS and ERP Company Software.
• Attention to detail.
• Minimum 4 days onsite requirement to support the business.
• Must be able to use basic office equipment: Computer, Printer, Copier, Telephone, etc.
• Must be capable of communicating with stakeholders.

Nice To Haves

• Experience with Salesforce and/or Epicor
• Experience with in vitro diagnostics (IVD / IVDR) is preferred, other applicable experience is a plus.
• Familiarity with Power BI

Responsibilities

• Primary ownership for complaints and post-market surveillance utilizing the SalesForce platform.
• Initiate complaint files and document complaint and regulatory reportability assessment within the Complaint Handling System per Advanced Instruments procedures, GMPs, 21 CFR 803, 820, ISO 13485, and other applicable national regulatory requirements.
• Make reportability decisions 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, perform risk assessments, make corrective action assessments based on investigation findings, and close complaints.
• Provide support to cross-functional teams related 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 all product families
• Execute PMS plans in the commercial 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.

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 (job specific)
• Professional development, engagement and events
• Company marketplace for lunch and snacks! (location specific)
• Company subsidized cafeteria (Waltham)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed