Regulatory Affairs Specialist I

Additional Locations: Costa Rica-Heredia

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:
The Regulatory Affairs Specialist I supports Global Regulatory Affairs Operations by executing critical regulatory processes that help maintain compliance with global medical device regulations and business requirements. This role collaborates with divisional and country regulatory specialists, and cross-functional partners to support Notified Body activities, regulatory certificates, vendor invoicing, translation services, and regulatory information management.

Work Mode 

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Heredia, Costa Rica and requires being on-site at least three days per week. 

Responsibilities:

Notified Body Support

• Support Notified Body activities by tracking requests, coordinating responses, managing regulatory deliverables, and following up on related commitments and stakeholder actions.
• Maintain accurate and current Notified Body records, trackers, and supporting documentation in uTrack and other applicable regulatory systems.

Vendor and Translation Management

• Own regulatory vendor invoicing activities, including invoice tracking, reconciliation, payment follow-up, and issue resolution.
• Coordinate translation requests with external vendors and internal stakeholders to ensure timely delivery of completed regulatory documents.

Regulatory Systems and Process Improvement (Utrack)

• Maintain regulatory records, databases, trackers, and supporting documentation to support data accuracy, traceability, and compliance.
• Monitor operational requests and commitments, identify risks or gaps, escalate issues as appropriate, and support improvements that increase process efficiency and reliability.

Minimum Qualifications:

• Bachelor's degree in a scientific, technical, business, healthcare, or related field, or equivalent experience.
• 0-2 years of experience in Regulatory Affairs, Quality, Healthcare, Finance Operations, or a related discipline.
• Strong organizational, analytical, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to effectively manage multiple priorities and deadlines.
• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and Teams.

Preferred Qualifications:

• Experience with regulatory operations, medical device compliance, or quality systems.
• Knowledge of Notified Body processes and regulatory certificate management.
• Experience with SAP, Ariba, uTrack, SharePoint, eRIM, Rimsys, or similar systems.
• Familiarity with FDA, EU MDR, ISO 13485, or international medical device regulations.
• Experience managing vendor relationships, invoicing processes, and translation services.

Requisition ID: 634315

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.