Post Market Surveillance Specialist, Contract

novabio; Waltham (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Nova Biomedical in Billerica, MA is seeking a Post Market Surveillance Specialist to lead reporting, meetings, and compliance activities within the Post Market department.

You will collect and analyze post-production information, develop SOPs, monitor KPIs, and support regulatory submissions such as MDRs.

Collaborate with Regulatory Affairs, R&D, Manufacturing, and Quality teams to ensure adherence to FDA and IVDR requirements and maintain a compliant quality system.

Qualifications

• Bachelor’s degree in a scientific or technical discipline.
• Minimum of three years of experience within the medical device or diagnostic industry.
• Minimum of two years of post-market surveillance, complaint handling, customer support, and/or quality assurance experience within a medical device or diagnostic environment.
• Experience submitting Medical Device Reports (MDRs) and/or adverse event reports to regulatory agencies.
• Experience with post-market surveillance activities in accordance with IVDR regulations preferred.
• Experience writing corporate-level Standard Operating Procedures (SOPs) within a GMP environment.
• Experience performing data analysis on post-market, quality assurance, or other quality system data.
• Medical diagnostic or medical device experience required.
• Experience working within FDA-regulated or other regulated environments.

Responsibilities

• Compile, analyze, and report post-production information as part of the Post-Market Surveillance system.
• Lead ongoing Post Market Surveillance meetings for various product families.
• Assist in developing and updating policies and procedures as needed.
• Evaluate the effectiveness of current processes through KPI monitoring and risk assessments.
• Report issues to management to support timely resolution of customer complaints.
• Mentor team members on complaint handling processes and regulatory compliance requirements.
• Maintain collaborative relationships with peers and colleagues to support departmental objectives.
• Support activities related to complaint handling systems and post-market compliance programs.

Skills

PMS reporting

Regulatory compliance

MDR reporting

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in a scientific or technical discipline

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 Surveillance (PMS) Specialist is responsible for preparing Post-Market Surveillance reports, conducting PMS meetings, and supporting the Post Market department in maintaining complaint handling systems, metrics, policies, and procedures to ensure compliance with applicable worldwide regulations and requirements. This role works closely with cross-functional teams to collect, analyze, and report post-production information while supporting ongoing quality and regulatory compliance initiatives.

Responsibilities:

• Compile, analyze, and report post-production information as part of the Post-Market Surveillance system.
• Lead ongoing Post Market Surveillance meetings for various product families.
• Assist in developing and updating policies and procedures as needed.
• Evaluate the effectiveness of current processes through KPI monitoring and risk assessments.
• Report issues to management to support timely resolution of customer complaints.
• Mentor team members on complaint handling processes and regulatory compliance requirements.
• Maintain collaborative relationships with peers and colleagues to support departmental objectives.
• Support activities related to complaint handling systems and post-market compliance programs.
• Interact with Regulatory Affairs, R&D, Manufacturing, Engineering, Quality Control, Supplier Quality, Incoming Inspection, Purchasing, and Technical Support teams.
• Perform other duties as assigned.

Experience Requirements:

• Bachelor’s degree in a scientific or technical discipline.
• Minimum of three years of experience within the medical device or diagnostic industry.
• Minimum of two years of post-market surveillance, complaint handling, customer support, and/or quality assurance experience within a medical device or diagnostic environment.
• Experience submitting Medical Device Reports (MDRs) and/or adverse event reports to regulatory agencies.
• Experience with post-market surveillance activities in accordance with IVDR regulations preferred.
• Experience writing corporate-level Standard Operating Procedures (SOPs) within a GMP environment.
• Experience performing data analysis on post-market, quality assurance, or other quality system data.
• Medical diagnostic or medical device experience required.
• Experience working within FDA-regulated or other regulated environments.
• Knowledge of auditing, statistics, and database management preferred.

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.

Work Location: Billerica, MA

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

Privacy Policy

https://www.novabiomedical.com/privacy-policy/

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.