Regulatory Affairs Specialist II

Job description

**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 **Regulatory Affairs Specialist II** to work in our rapidly growing Interventional Therapies Division. **Your Responsibilities:** - Cross functional collaboration and review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory submissions - Liaise with International BSC Regulatory Affairs colleagues on product and manufacturing changes to support information requests and international submissions - Support the coordination, writing, and submission of U.S. and EU regulatory submissions for modified products and manufacturing changes - Maintain EU MDR Technical Documentation - Represent RA on cross functional project teams - Participate in corporate and department training **Minimum Requirements:** - Minimum of a bachelor’s degree or related field - 2+ years regulatory affairs or related experience - Ability to collaborate with cross-functional team members to gain understanding of technical information through thoughtful questioning and engagement with team members - Ability to communicate technical information and complex ideas clearly and succinctly both orally and in writing - Demonstrated ability to effectively manage multiple projects and priorities and execute in a timeline driven environment - Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat - Advance English Level **Requisition ID:**637186 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.