Boston Scientific Regulatory Affairs Specialist 

United States, Massachusetts, Marlborough 

625054483

The Regulatory Affairs Specialist I will provide support to the Urology Regulatory Affairs Operations group. Primary responsibilities include support of clinical risk and post market surveillance activities, audits, and Urology Regulatory Affairs Operations strategic initiatives.

This is a hybrid position (in the office minimum of three days per week) with the flexibility to be located in Marlborough, MA, Minnetonka, MN or Arden Hills, MN. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Key Responsibilities

• Support development of summary of safety and clinical performance reports (SSCPs), clinical evaluation reports (CERs), post-market clinical follow-up (PMCF), and periodic surveillance update reports (PSURs) in alignment with applicable post market, clinical and regulatory standards and business needs
• Responsible for the preparation and submission of EU Post Market Surveillance submissions to the Notified Body
• Assists in developing and maintaining positive relationships with device reviewers through oral and written communications regarding post market surveillance, pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
• May assist with reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
• Support regulatory audits, as required
• Support and maintain Quality initiatives in accordance with BSC Quality Policy
• Continuously assess ways to improve Quality

Required Qualifications

• A minimum of a Bachelor’s Degree
• A minimum of 2 years' work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
• Prior experience with regulatory submissions writing
• General understanding of product development process and design controls
• Working knowledge of FDA, EU and/or international regulations
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)

Preferred Qualifications

• Bachelor’s degree in a scientific or technical discipline
• Prior experience with drafting or reviewing SSCP, post market surveillance or clinical risk reports
• General understanding of regulations applicable to post market surveillance and product development
• Ability to manage several projects simultaneously
• Effective research and analytical skills
• Excellent written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision
• Strong interpersonal and influencing skills
  

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.