Posted: Monday, March 13, 2017 11:18 PM
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?
Weve seen the difference that neuromodulation technology such as spinal cord stimulation and deep brain stimulation can make. These breakthroughs have helped more than 400,000 people worldwide over the past four decades. But there is still enormous potential to help even more people. In our drive to be the world leader in neurological devices, we strive to improve every life we touch through our dedication to innovation, our commitment to people, and our passion for performance.
Support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory requirements.
1. Prepare submissions(i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products
2. In conjunction with Clinical Research, support the preparation of applications (i.e., IDE, IDE supplements, Investigator Brochure) for conducting clinical investigations in U.S., Canada, Australia and EU countries.
3. Prepare required submissions (progress reports, etc.) to facilitate the continuation of clinical studies.
4. Participate in the review and submission activities (annual reports, change notifications, etc.) to support the maintenance of marketing approvals.
5. Support product registrations for international markets as required.
6. Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
7. Other duties as assigned.
:BS in Scientific discipline/engineering required.
:5+ years of experience in the area of worldwide regulatory affairs in Post Marketing Assessment (both submissions and compliance) at medical device industry.
:Class III Medical Device experience
:Knowledge and experience of U.S. FDA, Canada and EU regulations and standards.
:7+ years of PMA
:Interpersonal, communication and negotiating skills.
:RA certification (by Regulatory Affairs Professional Society)
Boston Scientific is an equal opportunity employer.
• Location: San Fernando Valley, valencia
• Post ID: 104027878 sanfernandovalley