Boston Scientific Regulatory Affairs Specialist II 

United States, Minnesota 

229244799

About the role:

This Regulatory Affairs Specialist II role will be a part of the Interventional Cardiology Regulatory Affairs team and will be supporting regulatory submission activities to obtain and maintain regulatory approvals for specific medical devices. In this role you will participate in activities to ensure compliance with worldwide regulatory requirements.

Your responsibilities include:

• Acts as a company representative, 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 with developing and implementing regulatory strategies for new and modified medical devices
• Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
• Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation
• Support product registrations for international markets as required
• Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations
• 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 in a scientific, technical, or related discipline
• At least 2 years' experiencein regulatory affairs or related discipline within the medical device industry (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
• Introductory knowledge of US FDA and EU regulations for medical devices
• Basic computer skills, including experience with software applications such as Microsoft Word, Excel, Teams, and PowerPoint and Adobe Acrobat

Preferred qualifications:

• Minimum of 1 year in a Regulatory Affairs role
• Working knowledge of FDA, EU, and international regulations for medical devices
• Basic knowledge in design and manufacturing processes
• Ability to manage several projects of moderate scope and complexity simultaneously while adhering to time schedules
• Effective research, analytical, and problem-solving skills
• Excellent written and oral communication, technical writing, and editing skills. Ability to translate technical information into a clearly written message for regulators
• Advanced computer skills to support submissions and communication or presentations both internally and externally (e.g., MS Word troubleshooting such as linkages/references, page numbers, Section building, Table of Contents, etc.)
• Quick learner, self-motivated, and independent worker with minimal supervision
• Works well in fast-paced cross-functional team environments

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.