The Supervisor Medical Device Reporting manages Medical Device Reporting activities and assigned resources; ensuring compliance with all laws and regulations related to the management of product complaints and submission of reports related to Adverse Event/Medical Device Reporting.
Direct the activities of the MDR group to ensure appropriate product analysis results and submission of Medical Device Reports (MDRs).
Evaluate device malfunctions and adverse events involving Spacelabs Healthcare products to determine Medical Device Report (MDR) eligibility; 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.
Interface with appropriate Company personnel inside and outside the U.S. to ensure that international reporting requirements are met. Work with appropriate EU-authorized representatives, notified bodies, and Ministry of Health bodies in establishing and maintaining compliant vigilance programs.
Establish and update/maintain written procedures on an ongoing basis to ensure continued compliance with domestic and international regulatory requirements.
Monitor key performance indicators and report information to upper management as required.
Assess department needs to recruit and train personnel; set standards of performance; select, appraise, train, and coach team members to meet performance standards.
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.
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 compliance and support post-market surveillance.
Respond in a timely manner to requests for additional information from US and OUS regulatory agencies.
Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company’s values, Code of Ethics and Conduct, and applicable compliance policies.
Manage, evaluate and develop team of employees to meet functional deliverables and responsibilities. Complete company people management requirements. Exhibit manager core competencies.
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 related field, or equivalent combination of education and highly relevant experience.
4+ years’ experience in medical device industry, or 4+ years’ experience in cardiovascular/respiratory clinical environment (in a hospital) is required.
2+ years’ experience leading or managing teams.
Demonstrated ability to communicate effectively over the telephone and in person with staff at all levels of the organization. Strong technical writing skills required. Ability to present to large audiences desirable.
Demonstrated proficiency with computer skills: MS Office applications, Agile PLM or other medical device quality or enterprise database systems. Extensive use of computer: >90%.
Ability to multi task and drive practical results to a timely conclusion.
Self-motivated and organized; strong analytical skills.
Experience/formal training in business/liability/risk management.
Customer service and/or technical support experience.
Knowledge and application of complaint handling regulations, Medical Device Reporting, HIPAA requirements and other quality standards.
Must be able to complete job responsibilities working with different time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs: 15%.
Travel: Some domestic travel is required <5%.
Employer will assist with relocation costs.
Additional Salary Information: Target compensation is $90,000
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!