Boston Scientific Regulatory Affairs Specialist III 

United States, Minnesota 

136179723

In this role, you’ll be part of a high-functioning, close-knit Regulatory Affairs team responsible for support of submissions and on-going regulatory compliance through partnership with our global R&D, manufacturing, clinical, and quality teams.

Required qualifications:

• Bachelor’s Degree
• Minimum of 3 years of experience in Regulatory Affairs or a related discipline within medical devices (such as R&D, Quality, Clinical, Biocompatibility, or Labeling), including at least 2 years specifically in a Regulatory Affairs role
• Knowledge of US and EU medical device classification and submission pathways
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred qualifications:

• Previous experience with Class II and III medical devices change assessments and submissions
• Ability to communicate complex ideas clearly and concisely (both verbally and in writing)
• Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment
• Experience working directly with FDA, notified bodies and/or international health authorities
• BA/BS Degree in life sciences, engineering or an equivalent
  

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.