Sr. Post Market Surveillance Specialist

Overview

At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.

Why work at Spacelabs? Because lives depend on you!

The Senior Post-Market Surveillance Specialist is responsible for maintaining all Spacelabs Post-Market Surveillance programs, including but not limited to Complaint Handling, Vigilance Reporting, Product Safety Issue Assessment (defect assessment, Health Hazard Evaluation (HHE), etc), and Field Safety Corrective Action. This role will work cross-functionally with multiple groups to escalate any potential safety concerns and defects, and is a key member in gathering, analyzing, and reporting on the field activities, clinical performance, and safety of our devices.

This is a highly visible, high-impact role that will oversee all activities related to post-market surveillance and compliance (including complaint management, vigilance reporting, product monitoring, product safety, post-market clinical follow-up, and clinical quality) associated with Spacelabs products. The Post Market Surveillance Specialist will ensure that complaint records are handled appropriately and that safety-related issues are escalated appropriately.

This role requires an understanding of global regulatory obligations and is responsible for ensuring compliance with FDA, EU MDR, Competent Authority, Notified Body, Health Canada, TGA, MHRA, and Rest of World (ROW) requirements.

• This position is hybrid based in Snoqualmie, Washington. The expectation for on site collaboration is 3+ days per week.

Responsibilities

Qualifications

#LI-Hybrid

#TC-1

Please review our benefits here : Life at OSI

The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location and date of hire. Please note that the salary information shown above is a general guideline only. Salaries are based upon candidate experience and qualifications, as well as market and business considerations.

NOTICE TO THIRD PARTY AGENCIES

OSI Systems, Inc. and its subsidiaries (collectively "OSI") does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and / or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

Equal Opportunity Employer - Disability and Veteran

Know Your Rights

Poster Link :

OSI Systems, Inc. has three operating divisions : (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.