Posted: Tuesday, March 14, 2017 4:16 PM
Primary Location: US:CA:Valencia
Additional Locations: (n/a)
Why join Boston Scientific Neuromodulation in California?
We integrate all global operations at our worldwide headquarters in Valencia, California, close to Los Angeles, close to the beach, close to the mountains, close to the desert. All the advantages of Southern California but more affordable than many other areas nearby. Looking for onsite amenities? We have an on:campus bistro, credit union, gym, and Toastmasters club. Take advantage of 360 days of sunshine a year on our basketball and volleyball courts. Join our softball and soccer teams. We even have cricket and dragon boat racing teams We also offer numerous volunteer activities and events in the wonderful communities of Valencia and Santa Clarita. If you like to work hard and play hard, youll fit right in. And youll be well rewarded. Our salaries are competitive. Our benefits package is generous. And our 401K program? Forbes ranks it one of the top 10 in the country
What makes Boston Scientific Neuromodulation so special?
Our mission at Boston Scientific is to transform lives of patients worldwide through innovative medical solutions. We deliver cutting edge products that help clinicians improve the lives of patients every single day and have a profound impact on the quality of medical care around the world. As we fulfill this responsibility to continue to transform the field of medical technology, we seek dedicated individuals who possess the passion, integrity and creative spirit needed to thrive in a fast paced innovative company.
Boston Scientific Neuromodulation business is the recognized leading innovator of microelectronic technologies that modulate neural activity to treat chronic disabling disorders, including spinal cord stimulation for the treatment of chronic pain and deep brain stimulation for Parkinsons disease, essential tremor and dystonia. Today, we are developing breakthrough technologies and new indications to help those suffering from neurological disorders, including migraine headaches and depression, among others. Join a dynamic global organization that is fueled by the diversity and best in class talent of its entire workforce.
Analyzes customer complaints to determine which are regulatory reportable and is a key contact for activities with internal, field, and end use customers. Responsible for adherence to, and interpretation of, Good Manufacturing Practices (GMPs), complaint handling per the Code of Federal Register (CFR), and all other applicable international governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
: Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
: Serves as internal consultant on regulatory issues, field actions, and report decision:making. External government contact person, in addition to writing, reviewing, and auditing departmental Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
: Is an expert in clinical settings related to product application. Evaluates identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis. Department mentor/trainer.
: Drives regulatory reporting decisions using event investigation and regulatory decision models. Writes and develops decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations.
: Develop and deliver presentations to global regulatory agencies. Topics may include
• Location: San Fernando Valley, valencia
• Post ID: 104314598 sanfernandovalley