Posted: Monday, March 13, 2017 10:48 PM
Primary Location: US:CA:Valencia
Additional Locations: (n/a)
Hiring Manager: Talar Tahmasian
Recruiter: Lucille Crawford Asare
An exciting opportunity
Chronic pain affects hundreds of millions of people worldwide, including more than 100 million in the US alone. Our global mission:our passion and purpose:is to help these people with cutting:edge technologies. We helped develop the science of Neuromodulation. We are leaders in Spinal Cord Stimulation: the use of implanted electrical devices to help relieve pain. We are also a leader in DBS: deep brain stimulation. People with a passion to improve lives created these solutions and are hard at work on other breakthroughs. If you share our passion to truly make a difference, please join us. With Boston Scientific Neuromodulation, you will have a unique opportunity to change peoples lives by (. . .)
A rewarding environment
If you love the ocean, the mountains, the desert and the city, youll love our global corporate headquarters and integrated operations in beautiful, affordable Valencia, California, just north of Los Angeles. Enjoy 300+ days a year of sunshine. Perfect to take advantage of our on:campus basketball and volleyball courts. Join our company softball and soccer teams. And enjoy other onsite amenities including an on:campus bistro, credit union, brand new gym, Toastmasters club, and much more. You will be well:rewarded for your passion to help people. Our salaries are competitive. Our benefits package is generous. And Forbes ranks our 401(k) program one of the top 10 in the country Maybe best of all, your co:workers are smart, committed, and fun.
A global leader
At Boston Scientific Neuromodulation, you join a team that pioneered in the fields of Spinal Cord Stimulation and Deep Brain Stimulation (DBS). But we dont rest on our laurels. We never stop looking for ways to advance these state:of:the:art technologies and improve. And over the past four decades, Neuromodulation technology has helped relieve pain and other symptoms for more than 400,000 people worldwide. But theres still so much more to do. So much more potential. So many more opportunities. So many more unmet needs. If you have the dedication, the drive, and the determination to help take Neuromodulation:and Boston Scientific:to the next level of excellence, we need you and want you.
Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
The responsibilities of this position include but are not limited to:
: Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations using established decision models and internal processes.
: Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis
: Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
: Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmition to the appropriate regulatory authorities.
: Apply codes to events to facilitate product performance trending. Review coding and investigations with engineering, laboratory, and other internal staff.
: Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use cu
• Location: San Fernando Valley
• Post ID: 104179943 sanfernandovalley