Sr. Post Market Surveillance Specialist

At Spacelabs Healthcare, you make a difference.

Every member of our worldwide team plays an integral role in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit each year from the advancements we make in patient monitoring and management, care coordination, and clinical decision support.

Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance patient experience, improve population health, reduce costs, support care team well-being, and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.

Because while we may not be at a patient's bedside, their health is still in our hands.

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.***

The Post-market Surveillance Specialist is ultimately responsible for:

• Timely submission of Medical Device Reports (MDR) and other ROW equivalent for adverse events and malfunctions as required.
• Participate in Field Corrective Actions (FCA) activities, including but not limited to creation of the applicable regulatory reports, customer/distributor facing recall communication documents, Internal communication documents, and consignee lists.
• Escalation of product defects, design issues, and usability concerns
• Support in the complaints handling process to ensure timely handling of complaint records, investigations, defect escalations, and closure
• Participating in the Health Hazard Evaluation process/meetings
• Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity
• Maintaining competency of global medical device regulations in relation to Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF), and Clinical Evaluation Reports (CERs), and responsibility for executing regulatory requirements in accordance with ISO13485, MDR 2017/745, 21CFR Part 820, and others as required.
• Scheduling, preparing, and submitting Post Market Surveillance plans and reports. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
• Working with Quality Engineering, R&D, Clinical, and other applicable functions to support product clinical evaluation for the total clinical lifecycle in compliance with EU MDR, MDSAP, ISO 13485, ISO14971, and other laws, regulations, and product standards.
• Support QMS Corrective Action, Supplier Corrective Action, Internal Audits, and other improvement efforts that have escalated or were driven by complaints, fielded product issues, clinical safety or efficacy, or related concerns.
• Acquire data from primary or secondary data sources and maintain databases/data systems, and identify, analyze, and begin to interpret trends or patterns in data sets.
• Supporting regulatory audits and inspections by representing post-market activities, procedures, and records.
• Empower all company staff to provide feedback on product safety and efficacy concerns and issues.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Uphold the company's core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the company's Code of Ethics and Conduct.
• It is the responsibility of every Spacelabs Healthcare employee to report to their manager, or a member of senior management, any quality problems or defects for corrective action to be implemented and to avoid recurrence of the problem.
• Must maintain company quality standards and make quality decisions
• Duties may be modified or assigned at any time to meet the needs of the business.

• Bachelor's degree in Biomedical Engineering, Regulatory Affairs, or related field preferred; or combination of additional relevant experience and education in lieu of degree.
• 4+ years' experience in Complaint Handling, Postmarket Surveillance, or related position.
• 4+ years' experience in medical device industry required.
• Strong working knowledge of FDA, EUMDR, CMDR, MHRA, TGA, and related ROW regulations.
• Experience drafting and submitting global adverse event and recall reports.
• Strong practical knowledge of risk management principles and practices.
• Proficient in the use of Microsoft Office tools (Excel, Word, PowerPoint).
• Detail-oriented with strong technical and scientific writing skills.
• Ability to learn how to use the Spacelabs Healthcare products that are supported (training provided).
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must maintain company quality standards and make quality decisions.
• Must have effective communication skills and the ability to work in collaborative and independent work situations and environments with minimal supervision.
• Must have the ability to remain calm while effectively operating in urgent and exigent circumstances.
• Project Management skills are preferred.
• Experience with quality management preferred.
• Must have knowledge of statistical methods and quantitative analysis.
• Experience with analytical processes, tools, and dashboarding.
• Must be able to perform critical thinking to identify and synthesize patterns from emerging trends and translate them into actionable recommendations.

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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.

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.

Poster Link:

https://www.eeoc.gov/sites/default/files/2023-06/22- 088_EEOC_KnowYourRights6.12ScreenRdr.pdf

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.