Post Market Associate

Career Opportunities with Nova Biomedical Corporation

Nova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities.

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.

Job Summary:

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.

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.

Experience Requirements:

• Knowledge of ISO 13485, MDSAP, and FDA Quality System Regulations required.
• Experience with additional global regulatory requirements preferred.
• Proficiency with Microsoft Office and Adobe applications.
• Experience working with eQMS and ERP systems.
• Experience with Salesforce.
• Experience with Power BI.
• Experience with in vitro diagnostics (IVD/IVDR) preferred.
• Strong attention to detail.
• 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.

Physical Requirements and

Working Conditions:

• Comfort with working at a computer for extended periods.
• Capacity to lift and carry up to [25–50] pounds as required
• Able to communicate effectively via phone, video, and written communication.
• Occasional need to move about the office to access meetings or resources.

Why Work for Nova Biomedical

• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• 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

Work Location:
Waltham

Targeted Salary Range: $37.87-$47.48/hr

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base…