Regulatory Affairs Specialist Ii - Valencia, United States - Boston Scientific Corporation

Boston Scientific Corporation

Verified Company

Valencia, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Work mode:
Remote in Country
Onsite Location(s):Valencia, CA, US, 91355
Recruiter: Spencer Gregory Hale
Regulatory Affairs Specialist II - Neuromodulation

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 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.

Required qualifications:

A minimum of a bachelor's degree and 13 years' work experience in regulatory affairs or a masters in regulatory sciences.
Prior experience with class III Medical Devices
Knowledge and experience with U.S. FDA, Canada, EU, and/or international regulations and standards.
Effective written and oral communication, technical writing and editing skills
Works well in fastpaced crossfunctional team environments

Preferred qualifications:

Minimum of 7 years experience with Post Market Assessment
Interpersonal, communication and negotiating skills.
RA certification (by Regulatory Affairs Professional Society)

Requisition ID:580902-
Nearest Major Market:Los Angeles

Job Segment:
Regulatory Affairs, Medical Research, Clinical Research, Compliance, Law, Legal, Healthcare