Post Market Surveillance Specialist - Marlborough, MA

Job Summary

The Post Market Surveillance Specialist is responsible for monitoring the performance and safety of IPG Medical devices in postmarket settings to ensure compliance with global regulatory requirements and to maintain high standards of quality and patient safety. This role works directly with customers to gather accurate complaint information and supports failure analysis, adverse event investigations, and regulatory reporting. The specialist collaborates crossfunctionally to identify trends, drive corrective and preventive actions, and promote continuous improvement throughout the product lifecycle.

Key Responsibilities

• Monitor and evaluate the performance of medical devices in postmarket settings to ensure compliance with applicable regulatory requirements and to maintain high levels of safety and quality.
• Work directly with customers to obtain complete and accurate complaint information and to support failure analysis activities.
• Conduct thorough and timely investigations of adverse events and complaints related to medical devices.
• Collaborate with crossfunctional teams to gather and analyze data, identify trends, and support the implementation of corrective and preventive actions (CAPA).
• Develop, maintain, and continuously improve postmarket surveillance procedures and processes to ensure compliance with regulatory standards.
• Maintain accurate, detailed, and auditready records of postmarket surveillance activities, analyses, and findings.
• Communicate with regulatory agencies and respond to inquiries or requests related to postmarket surveillance activities.
• Participate in internal and external audits and inspections to demonstrate compliance with regulatory requirements.
• Stay current on industry regulations, standards, and best practices related to postmarket surveillance and communicate relevant updates to internal teams.
• Provide guidance and support to internal stakeholders on postmarket surveillance requirements, processes, and regulatory expectations.
• Identify opportunities for improvement and drive continuous improvement initiatives to enhance the safety, quality, and performance of IPG Medical devices.
• Act as a subject matter expert on postmarket surveillance and regulatory compliance for IPG Medical products.

Promote a culture of patient safety, quality, and continuous improvement across the organization.

Qualifications

• Bachelor's degree or equivalent relevant work experience required.
• At least 3- 5 years of experience in postmarket surveillance within the medical device industry.
• Strong knowledge of medical device regulations and postmarket surveillance requirements.
• Demonstrated attention to detail and ability to manage complex documentation in a regulated environment.
• Strong analytical, communication, and crossfunctional collaboration skills.