Post Market Associate
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 SalesForce platform
- Initiate complaint files and document complaint and regulatory reportability assessment within the Complaint Handling System per Advanced Instruments procedures, GMP’s, 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
Skills
- 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
- Experience with Salesforce and/or Epicor
- 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, & 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)
Company Overview
Company H1B Sponsorship