Senior Regulatory Affairs Specialist

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes Working from Home and onsite. You will have the opportunity to discuss details in the interview. 

About the Role:

Boston Scientific (BSC) is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We are looking for a Senior Regulatory Affairs Specialist to work in our rapidly growing Interventional Therapies Division.

Your Responsibilities:

• Cross functional collaboration and review of complex product and manufacturing changes for compliance with applicable regulations, impact to regulatory submissions, and determination of appropriate regulatory strategies and actions.
• Liaise with International BSC Regulatory Affairs colleagues on product and manufacturing changes to support information requests, global regulatory strategies, and international submissions.
• Lead the coordination, writing, and submission of U.S., EU, and international regulatory submissions for modified products and manufacturing changes.
• Develop and implement regulatory strategies to support product and manufacturing changes, regulatory approvals, and continued market access.
• Maintain EU MDR Technical Documentation and provide regulatory guidance to ensure continued compliance throughout the product lifecycle.
• Represent RA on cross functional project teams, providing regulatory leadership, identifying regulatory risks, and influencing project decisions.
• Support and lead interactions with regulatory authorities and Notified Bodies, as appropriate.
• Provide regulatory guidance, training, and mentoring to less experienced team members.
• Participate in corporate and department training.

Minimum Requirements:

• Minimum of a bachelor’s degree or related field.
• 4+ years regulatory affairs or related experience.
• Demonstrated ability to independently evaluate complex product and manufacturing changes, determine regulatory impact, and recommend appropriate regulatory strategies and actions.
• Ability to lead cross-functional collaboration and gain an understanding of complex technical information through thoughtful questioning and engagement with team members.
• Ability to communicate technical information, regulatory risks, and complex ideas clearly and succinctly, both orally and in writing.
• Demonstrated ability to lead and effectively manage multiple complex projects and priorities and execute in a timeline driven environment.
• Demonstrated ability to exercise independent judgment, identify potential regulatory risks, and influence cross-functional project decisions.
• Ability to provide regulatory guidance, training, and mentoring to less experienced team members.
• Advanced submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat.
• Advanced English Level.

Requisition ID: 637298

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.