Two Exciting Opportunities in Regulatory Compliance!!

JOB TYPE: Full Time, Employee JOB CATEGORY: Quality Assurance/Safety CITY: Redmond STATE: WAAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Two Exciting Opportunities in Regulatory Compliance!! Medtronic. Careers with a passion for life. As the world’s leading medical technology company, we provide lifelong solutions to people with chronic disease. Every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We also are dedicated to the total well-being of our employees and have been recognized for eight of the last ten years by Fortune magazine as one of the “100 Best Companies to Work For.”  Work with the kind of people who not only love what they do but why they do it. SR. REGULATORY COMPLIANCE SPECIALIST REGULATORY COMPLIANCE SPECIALISTRedmond, WA Position Description Receive, document, investigate and resolve customer complaints related to the performance of Medtronic Physio-Control products. Assure compliance with all global laws and regulations related to the review of complaints and submission of Adverse Event reports for medical devices manufactured and/or distributed by Medtronic Physio-Control. Position Responsibilities 1. Receive incoming complaint reports on real and/or perceived issues via phone / written reports. 2. Work closely with device users to understand issues and ensure adequate resolution. 3. Create database and paper records in accordance with legal and good record keeping practices. 4. Ensure records of complaint investigation are adequate, accurate and timely. 5. Coordinate the return of material and/or product for analysis. 6. Collaborate with technical and/or clinical peers in cross functional groups to ensure a thorough product analysis. Take results and formulate a reasonable conclusion to the reported issue 7. Provide technical (product) and clinical support to customers, field sales and service personnel regarding device operation. 8. Evaluate complaints and determine if the submission of a Medical Device Report (MDR) is required. 9. Write and submit MDRs and/or Vigilance reports in accordance with regulatory requirements. 10. Perform trending analysis to alert management to trends. 11. Independently initiate, negotiate, follow up and resolve issues both with customers and internal cross functional working groups. 12. Works special assignments as needed regarding critical situations. Fills a leadership role within the department by assisting and providing direction to other team members in completion of day to day tasks. 13. Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting. 14. Participate in process and work flow improvement activity. 15. Perform other related duties as assigned. Basic Qualifications 2-year technical degree Minimum of 6 years experience as a Regulatory Compliance Specialist in Complaints and/or MDR Desired/Preferred Qualifications Extensive knowledge of world wide Quality System Regulations (FDA, ISO, CMDCAS, rPAL, etc…). Preferably with Class III devices. Solid Computer Skills with MS Office Applications, Query tools and Enterprise Database systems Quality focused with strong organization skills. Comfortable in a high stress environment. Strong analytical skills. Strong Customer service/technical support skills Demonstrated ability to communicate effectively over the telephone, in person and in written form. Ability to work with minimal supervision. Possess Leadership abilities. Must be able to communicate appropriate and adequately to all management levels, including public speaking and group presentation experience. Thorough understanding of application and use environment of defibrillators With people like you who have purpose, potential and passion, we’ll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life. To route your resume directly to the hiring department, visit www.medtronic.com/employment, select Job Opportunities-U.S. & Puerto Rico, then enter Requisition # 59751 & 59747 and apply online using “Apply to this Job” or “Add to Cart”. No agencies or phone calls, please. Medtronic is an equal opportunity employer committed to cultural diversity in the workforce. MEDTRONIC, INC.www.medtronic.com/employment     To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an euqal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/employment   Click here to see other Medtronic opportunities  Email this Job to a Friend