Boston Scientific Senior Regulatory Affairs Specialist 

United States, Massachusetts, Marlborough 

534198317

US-MA-Marlborough; US-MN-Arden Hills; US-MN-Minnetonka

Your responsibilities will include:

• Acting as company representative, developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarifications, responses to questions/inquiries, and follow-up of submissions under review
• Developing and implementing regulatory strategies for new and modified products
• Acting as a core member on sustaining and new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions
• Reviewing and approving design and manufacturing changes for existing products, ensuring compliance with applicable regulations and standard requirements
• Reviewing, providing input, and approving advertising and promotional materials, as needed
• Responsibilities for preparation and submission of global regulatory applications, as well as maintenance of internal regulatory file documentation
• Reviewing device labeling and advertising materials for compliance with global regulations and standard requirements; analyzes and recommends appropriate changes
• Solving or proposing solutions to a range of problems of varying scope and complexity through applying technical and/or functional experience or existing solutions
• Logically presents information to convey key messages and complex information to others
• Training to departmental and divisional policies and procedures
• May lead small projects or represent Urology Regulatory Affairs on corporate teams, as needed
• Fostering a work environment of continuous improvement in relation to BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility
• Supporting efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing

Required qualifications:

• Bachelor’s degree
• 3+ years of experience in Regulatory Affairs or related experiences
• Understanding of regulations applicable to medical devices
• Demonstrated proficiency of FDA, EU and/or international regulations
• Up to 10% travel

Preferred qualifications:

• Master’s Degree in a business, scientific or technical discipline
• Demonstrated proficiency in understanding product development process and design controls
• Experience with supporting implantable devices from a regulatory perspective
• Understanding of regulations applicable to the conduct of clinical trials
• Ability to manage several projects simultaneously
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision

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.