Regulatory Affairs Specialist II

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.
Team Purpose
Global Regulatory Affairs Operations (GRAO) is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions throughout the product lifecycle.
The Regulatory Affairs Specialist II partners with global, divisional, regional and local Regulatory Affairs teams to support product approvals and maintenance through effective change communication, product control execution and implementation activities. The role is expected to develop into the subject matter expert (SME) for Distribution and Product Control processes, with primary responsibility for Safety Nets, Change Notification (CN) implementation assessments and related distribution-control activities.
Key Responsibilities
Serve as a key contributor supporting global regulatory processes, process owners, process stewards and cross-functional partners. Responsibilities include:

- Distribution Product Control Regulatory SME: Serve as the GRAO SME in the processes, tools and business rules for Regulatory Product Controls. Advise Divisional RA, Local RA and Supply Chain on control strategies and issues to ensure compliant and agile product distribution. Act as business SME for workflow system upgrades, providing business requirements and testing system enhancements for acceptability.

- Product Control Execution: Implement, maintain and remove regulatory product controls based in approved regulatory strategies. Perform analysis to translate business needs into SAP rules and submit requests in appropriate workflow portal. Maintain clear traceability records with good documentation practices.

- Change Notification implementation: Use international regulatory feedback to identify where product controls are needed following medical device changes and recommend the appropriate control strategy. Advise Divisional RA on the best approach and partner with QA DPC, Supply Chain, and other stakeholders as needed to support compliant implementation.

- Control decisions: Utilize expertise to analyze appropriate Product Control settings in collaboration with Divisional/Local RA, QA DPC, and Supply Chain. As required, remove, update or retain controls based on approvals, revisions, sites and plants.

- Stakeholder communication: Maintain clear, customer-focused, and timely communication of requests, escalations, and risks with internal stakeholders. Escalate high-risk cases where required and maintain good documentation records.

- Business Process Leader and Compliance improvement: Own and maintain business procedures related to Product Controls, including implementing continuous improvements, support CAPA/NCEP, audit, and other investigation activities, and keep audit-ready records.
Required Qualifications

- Bachelor's degree or equivalent education and experience, plus at least 2-3 years in Regulatory Affairs or a related discipline (Quality Systems, R&D, Quality, Post Market or Supply Chain) in the medical device, pharmaceutical or healthcare industry.

- Strong written and oral English communication skills, with the ability to explain decisions, requirements and risks to global stakeholders.

- Strong analytical, problem-solving and decision-making skills, including assessing information across multiple systems and clearly document the rationale for decisions and recommendations..

- Ownership, accountability and attention to detail in time-sensitive, compliance-related work.

- Ability to collaborate and maintain a compliance and customer-focused mindset in cross-functional, geographically dispersed teams while managing multiple priorities.
Preferred Qualifications

- Experience with distribution controls, product controls, change notification implementation or regulatory change management.

- Working knowledge of SAP, DisCo, Windchill or comparable enterprise systems.

- Working knowledge of FDA, EU and/or international medical device regulations and quality-system requirements; experience supporting audits or quality-system activities (MDSAP, ISO 13485, CAPA, NCEP).

- Scientific, engineering, technical or data-focused background; proficiency with Microsoft Teams, Word, Excel (advanced Excel highly desirable) and PowerPoint; experience with basic data analytics or Power BI.

- Demonstrated leadership through influence, knowledge sharing, issue ownership and constructive teamwork.
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.