Regulatory Affairs Specialist III

Regulatory Affairs Specialist III

The Regulatory Affairs Specialist III will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

• Develops and implements 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
• Supports the coordination, drafting, and submitting of U.S. and EU regulatory filings for new and modified medical devices
• Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes
• Reviews change notifications and performs regulatory impact assessments for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions
• Supports technical or major business segment product lines, special projects or strategic initiatives
• Acts as 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
• Supports and maintains Quality initiatives in accordance with BSC Quality Policy
• Continuously assess ways to improve Quality

Required qualifications:

• Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline
• 3+ years relevant work experience, including experience with Regulatory Affairs in the medical device industry
• Working knowledge of FDA, EU MDR, and international regulations for medical devices
• General understanding of product development process and design control
• General understanding of regulations applicable to the conduct of clinical trials
• Ability to simultaneously manage several projects

Preferred qualifications:

• Prior experience working on submissions such as 510(k)s, PMAs, IDEs, EU MDR, or international regulatory registrations
• Proficiency with Microsoft Office
• Effective research, analytical, and problem-solving skills
• Effective written and oral communication, technical writing, and editing skills
• Ability to work independently with minimal supervision