Boston Scientific Regulatory Affairs Specialist II - Neuromodulation 

United States, California, Santa Clarita 

683072308

Spencer Gregory Hale

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:

• Support the preparation of 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.

Required qualifications:

• A minimum of a bachelor’s degree and 1-3 years’ work experience in regulatory affairs.
• 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 fast-paced cross-functional 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)

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.