Boston Scientific Regulatory Affairs Specialist II 

United States, California, Sunnyvale 

947263189

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.

This is a hybrid position (in office minimum three days per week) in Sunnyvale, CA.

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

Preferred qualifications:

• Effective written and oral communication, technical writing and editing skills
• Interpersonal, communication and negotiating skills
• Works well in fast-paced cross-functional team environments
• RA certification (by Regulatory Affairs Professional Society)

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.