Boston Scientific Regulatory Affairs Specialist II 

United States, California, Santa Clarita 

272258238

The Regulatory Affairs Specialist II will be a part of the Neuromodulation Regulatory Affairs team and will support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. In this role you will 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:

• Bachelor's Degree or equivalent work experience
• A minimum of 3 years' work experience in regulatory affairs or related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
• Knowledge and experience with U.S. FDA, EU, and/or international regulations and standards

Preferred qualifications:

• Prior experience with class III Medical Devices
• Minimum of 3 years’ experience with Post Market Assessment
• Interpersonal, communication and negotiating skills.
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments
• RA certification (by Regulatory Affairs Professional Society)

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.