Senior Reg Affairs Specialist Job at Boston Scientific Corporation
Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Valencia, California
Additional Locations: (n/a)
Purpose and Passion * Comprehensive Benefits * Life-Work Integration * Community * Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we re solving some of the most important healthcare industry challenges. Together, we re one global team committed to making a difference in people s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life s work.
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, you ll fit right in. And you ll 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*
We ve 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.
About the role:
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.
Your responsibilities include:
* Prepare submissions(i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products
* 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.
* Prepare required submissions (progress reports, etc.) to facilitate the continuation of clinical studies.
* Participate in the review and submission activities (annual reports, change notifications, etc.) to support the maintenance of marketing approvals.
* Support product registrations for international markets as required.
* Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
* Other duties as assigned.
What we re looking for:
* 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. 0-2 years experience with Masters degree.
* Class III Medical Device experience
* Knowledge and experience of U.S. FDA, Canada and EU regulations and standards.
* PMA experience
* Interpersonal, communication and negotiating skills.
* RA certification (by Regulatory Affairs Professional Society)
*Level of role will be determined based on candidate's experience
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you re looking to truly make a difference to people both around the world and around the corner, there s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 417071
Nearest Major Market: Los Angeles
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