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Sr. Regulatory Affairs Specialist

Boston Scientific-Valencia, CA, 91354, USA

Sr. Regulatory Affairs Specialist Requisition ID 25472 Full/Part Time Location Valencia, CA Description A. Primary Function - Prepare submissions 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. B. Duties and Responsibilities - 1. Generate submissions (i.e. PMA, 510(k), PMA supplements, CE marking applications, product registrations, etc.) to obtain various worldwide approvals to commercially distribute products. Produce subseque...
 

Regulatory Affairs Specialist Jobs in Valencia, California Jobs

General Employment | Valencia, CA, 91354 | 5-7
Keys & Responsibilities: -Candidate must have a BA/BS or MS degree in Life Sciences, Engineering, or health care-related discipline. -Candidate must have at least 5+ years of experience in the medical device industry, preferably in a manufacturing/R&D environment, including medical writing, clinical study design, regulatory submission, and regulatory review. Must have experience developing, writing, and organizing all aspects of the IDE/PMA/510(k)'s. -Candidate must have the ability to independently analyze and interpret novel clinical, medical and scientific data and knowledge of current U...
Boston Scientific | US - CA, Valencia, 91354 | 5-8
Company: Boston ScientificJob Title: Sr. Regulatory Affairs SpecialistLocation: Valencia,CAStatus: Full Time,EmployeeJob Category: Pharmaceutical/BiotechSr. Regulatory Affairs SpecialistDescription A. Primary Function - Prepare submissions 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.B. Duties and Responsibilities - 1. Generate submissions (i.e. PMA, 510(k), PMA supplements, CE marking applications, product registrations, etc....
 
 

Boston Scientific Jobs

BOSTON SCIENTIFIC | Waltham, MA, 00646 | 2-6
Click To View MORE THAN THE OPPORTUNITY OF A LIFETIME. THE OPPORTUNITY TO IMPROVE LIFE. For more than 25 years, Boston Scientific has been a pioneer in less-invasive medical devices delivering on our mission to improve the quality of patient care and the productivity of health care delivery worldwide We're a company that is committed to innovation and quality in everything we do. With ground-breaking products in development and a promising future ahead, every day offers us another opportunity to let the innovation spread. Engineer, Sr. Manufacturing / II CRM Operations Dorado, PR Provides s...
Boston Scientific | US - NY, New York, 10001 | >9
Company: Boston ScientificJob Title: Global Supply Chain Planning ManagerLocation: New York,New YorkStatus: Full-Time, EmployeeJob Category: Manufacturing OperationsGlobal Supply Chain Planning ManagerThe OpportunityGlobal Supply Chain Planning ManagerPosition ProfileJob Purpose:The WW demand planning activities required to meet customer needs, marketing / sales requirements and meet service level objectives. Also support, monitor and maintain finished goods inventory levels WW to meet desired service level commitments. Position Responsibilities: (Key responsibilities, authorities, and inte...
 
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