Post Market Associate

Job Description

Job Description

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 written communication skills.
• 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

• 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

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 salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.

About the company

At Nova Biomedical, we’re not just building instruments, we’re 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 Nova’s 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, we’re 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, we’re 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, you’ll 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 what’s next with us at novabiomedical.com

EEO Statement:

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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