Boston Scientific Regulatory Affairs Specialist 

United States, Minnesota, Maple Grove 

478086820

About the role:

We seek a dynamic individual focused on professional development in an innovative environment offering a diverse mix of regulatory opportunities encompassing the full life cycle of cardiovascular devices. If you are interested in a varied and important role and think you will be a good fit, please apply.

Your responsibilities will include:

• Assists in 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
• Assists in drafting regulatory strategies for new and modified medical devices
• Assists core team members on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle
• Assists with preparation and submission of regulatory applications, as well as internal regulatory file documentation
• Assists with reviewing device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes
• Assists with reviews and signs-off on product and manufacturing changes for compliance with applicable regulations

Required Qualifications:

• Bachelor’s Degree in life sciences, engineering or an equivalent
• 1+ year of technical or medical device experience (in industry or academics)
• Basic computer skills, including experience with Microsoft Office, Word, Excel, PowerPoint and Adobe Acrobat

Preferred Qualifications:

• Ability to communicate complex ideas clearly and simply both orally and in writing
• Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment
• 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.