Senior Regulatory Affairs Specialist

Boston Scientific • Santa Clarita, CA

304d • $86,600 - $164,500 • Hybrid

About The Position

At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets. The Senior Regulatory Affairs Specialist will be a part of the Neuromodulation Regulatory Affairs team. This individual will be responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

Requirements

• Bachelor's degree, minimum
• 4+ years Regulatory Affairs or related discipline in medical devices (R D, Quality, Clinical, Biocompatibility, Labeling, etc.)
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as various US PMA supplements, 510(k)s and EU MDR technical documentation
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Nice To Haves

• Previous experience in the medical device industry with Class II or III device submissions
• General understanding of product development process and design controls
• Working knowledge of FDA, EU and international regulations
• Ability to manage several projects
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments
• Team player with excellent interpersonal skills

Responsibilities

• Acts as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR
• Supports and implements the development of domestic and international strategies for Class II and III medical devices for new and modified medical devices
• Assists with departmental policy and procedure implementation
• Assists with Regulatory Affairs training to cross functional groups
• Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Reviews device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations
• Support international geographies to gain and maintain product approvals
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
• Supporting regulatory audits, as required

Benefits

• 401k
• health_insurance
• dental_insurance
• vision_insurance
• life_insurance
• disability_insurance
• paid_holidays
• paid_volunteer_time
• tuition_reimbursement
• professional_development

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree