Regulatory Affairs International Support Specialist II

Hiring Manager: Jennifer Amy Mardones Tschida
Recruiter: Jose Daniel Calderon Robles

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

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.

Hybrid Roles:

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

About this role:

With adequate supervision, the Regulatory Affairs International Support Specialist II is responsible for supporting international geographies to gain and maintain EP product approvals.

Your responsibilities will include:

• Prepare and provide appropriate documentation to international Regulatory partners for new product registrations and renewals.
• Prepare and provide appropriate documentation to international Regulatory partners to support change submissions.
• Support international requests for product release in collaboration with Division Regulatory product SME.
• Liaise with international Regulatory partners for various projects as directed.
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing.

What we’re looking for in you:

Minimum Qualifications

• Bachelor’s degree, minimum
• 2-3 years of experience in Regulatory Affairs or related field (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device industry
• Proven organizational skills, including ability to manage multiple tasks/requests
• Basic computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
• English proficiency 90%+

Preferred Qualifications

• Previous experience in the medical device industry
• General understanding of product development process and design controls
• Working knowledge of FDA, EU and international regulations
• Effective problem solving skills
• Effective written and oral communication

Requisition ID: 585669

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.