Boston Scientific Regulatory Affairs Specialist II 

United States, Massachusetts, Marlborough 

769642423

About the role:

The Regulatory Affairs Specialist II will provide support to the Urology Regulatory Affairs Operations group. Primary responsibilities include support of Notified Body activities, EUMDR, audits, process optimization and Urology Regulatory Affairs Operations strategic initiatives.

Your responsibilities will include:

• Under minimal supervision, acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Manages Urology’s Declaration of Conformity (DoC) process and reviews all DoCs for quality and accuracy
• Provides internal and external audit preparation and support
• Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations
• Reviews clinical and post market surveillance documentation for compliance with applicable regulatory requirements
• Supports innovation within RA by proposing optimization and efficiency strategies
• Support and maintain Quality initiatives in accordance with BSC Quality Policy
• Continuously assess ways to improve Quality

Required qualifications:

• Minimum 2 years of experience in regulated industry
• Bachelor's degree in a scientific field
• Ability to travel up to 15%

Preferred qualifications:

• Regulatory experience
• Medical device experience
• EUMDR experience
• Experience with GenAI and related tools

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.