Post Market Surveillance Specialist

IPG Photonics • Marlborough, MA

7d

About The Position

The Post Market Surveillance Specialist is responsible for monitoring the
performance and safety of IPG Medical devices in post‑market 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
cross‑functionally to identify trends, drive corrective and preventive actions,
and promote continuous improvement throughout the product lifecycle.

Requirements

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

Responsibilities

• Monitor and evaluate the performance of medical devices in post‑market 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 cross‑functional teams to gather and analyze data, identify trends, and support the implementation of corrective and preventive actions (CAPA).
• Develop, maintain, and continuously improve post‑market surveillance procedures and processes to ensure compliance with regulatory standards.
• Maintain accurate, detailed, and audit‑ready records of post‑market surveillance activities, analyses, and findings.
• Communicate with regulatory agencies and respond to inquiries or requests related to post‑market 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 post‑market surveillance and communicate relevant updates to internal teams.
• Provide guidance and support to internal stakeholders on post‑market 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 post‑market surveillance and regulatory compliance for IPG Medical products.
• Promote a culture of patient safety, quality, and continuous improvement across the organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees