Boston Scientific Senior Regulatory Affairs Specialist - Peripheral Interventions 

United States, Minnesota 

202535606

Your responsibilities will include:

• Support the development of domestic and international strategies for Class II and III medical devices
  Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR
• Support international geographies to gain and maintain product approvals
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
• Supporting regulatory audits, as required

Required Qualifications:

• Bachelor’s degree, minimum
• 4+ years of experience in Regulatory Affairs or a related discipline in the medical device industry (such as R&D, Quality, Clinical, Biocompatibility, or Labeling), with at least 2 of those years specifically in Regulatory Affairs
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as US 510(k)s and EU MDR technical documentation
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred Qualifications:

• Previous experience supporting medical electrical equipment
• General understanding of product development process and design controls
• Working knowledge of US FDA, EU, and international regulations
• Ability to manage several projects
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments
• Team player with excellent interpersonal 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.