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.
Can sit in Billerica, Waltham, Norwood or Westbrook, Maine. Must train 1 week onsite in Billerica.
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.
