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!
Evaluate device malfunctions and adverse events involving Spacelabs Healthcare products to determine Medical Device Report (MDR) eligibility to the USA and vigilance reporting to the rest of the world. Report MDR eligible events to the U.S. Food and Drug Administration (FDA) within the MDR regulatory requirements. Identify and initiate product event investigations to satisfy MDR requirements as needed. Follow company procedures for vigilance reporting to the rest of the world.
- Ensure complete, accurate and timely reporting of MDR/vigilance data as required by regulatory agencies.
- Evaluate incoming field reports, product returns and product analysis results for Spacelabs Healthcare products as necessary to determine MDR
- Perform detailed investigation of adverse events by contacting internal resources, Spacelabs Healthcare field personnel and/or customers as appropriate. Generate medical device rationale or Medical Device Report for all products complaints.
- Initiate and complete MedWatch reports for timely submission to the FDA. Conduct follow up investigations for reported events and assist in data collection for trending purposes.
- Assist in preparing correspondence for FDA requests and support inspections and audits.
- Develop and maintain integrated system post market safety reports for devices.
- Provide input on internal system and methods to maintain MDR/vigilance compliance and support post-market surveillance.
- Respond in a timely manner to requests for additional information from US and OUS regulatory agencies.
- Develop SOPs and guidance documents to assist other staff with device field event evaluation.
- 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 in order for corrective action to be implemented and to avoid recurrence of the problem.
- Duties may be modified or assigned at any time to meet the needs of the business.
- Bachelor’s degree in Health Care, Health Sciences or Bio-Medical Engineering or equivalent combination of education and highly relevant experience.
- Medical device or similar highly regulated industry is required (Level determined by overall relevant experience; including min 3+ for level 2, 6+ level 3). A minimum of 2 years hands-on experience with medical device reporting or complaint handling preferred.
- Excellent communication skills, over the telephone, in person, and in writing.
- Knowledge and application of complaint handling regulations, medical device reporting and other quality standards.
- Knowledge of 21 CFR Part 820, Quality Systems Regulations.
- Knowledge of 21 CFR Part 803, Medical Device Reporting.
- High level of computer proficiency is required.
- Experience/formal training in business/liability/risk management
- Complaint handling and/or customer service and/or technical support experience
- Knowledge of medical events
- Strong analytical skills
- Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA Statute
- Knowledge of the Medical Device Directive (MDD), 93/42/EEC
- Knowledge of Canadian Medical Device Regulation (CMDR
- Knowledge of the CFDA Medical Device GMP
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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 the Security and Healthcare divisions, as well as to external original equipment manufacturer clients for application in the defense, aerospace, medical and industrial markets, among others.