Regulatory Affairs Specialist II - Interventional Cardiology (Hybrid)

Regulatory Affairs Specialist II

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About the role : At Boston Scientific, we advance science for life by transforming deep clinical insights into meaningful innovations that improve patient lives. Our Interventional Cardiology (IC) division focuses on developing and delivering technologies to diagnose and treat coronary artery disease and other cardiovascular disorders. We are continually investing in both our robust product portfolio and our expanding global presence. As a Regulatory Affairs Specialist II, you will support a broad range of Interventional Cardiology devices, with an emphasis on sustaining commercial products and executing regulatory submissions for the US and EU. This role offers the opportunity to make a direct impact on patient care by ensuring product compliance and navigating global regulatory requirements.

Work model, sponsorship, relocation : At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include :

• Supporting Regulatory Affairs activities related to Renal Denervation devices within the Interventional Cardiology portfolio
• Representing Regulatory Affairs on core project teams by providing guidance throughout product development and lifecycle management
• Acting as a liaison with regulatory agencies through written and verbal communications, including submission strategy and pathway development
• Preparing and submitting regulatory documentation to support global compliance and product approvals
• Reviewing and approving product changes, labeling, and promotional materials to ensure regulatory compliance
• Participating in internal initiatives to improve quality systems in alignment with Boston Scientific's Quality Policy
• Supporting department and divisional process improvements through collaboration, best practice sharing, and cross-functional engagement
• Participating in regulatory audits by agencies such as the FDA, DEKRA, BSI, and HPRA

Qualifications : Required qualifications (hard skills) : A minimum of a Bachelor's degree in Science, Engineering, or a related discipline Minimum of 2 years' experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry Strong technical writing and editing abilities Ability to translate complex technical content for regulatory audiences Proficiency in Microsoft Word, Excel, Teams, PowerPoint, and Adobe Acrobat Working knowledge of FDA, EU, and international medical device regulations Preferred qualifications (soft skills) : Excellent written and verbal communication skills Strong interpersonal skills and a collaborative team mindset Self-starter with the ability to work independently and adapt quickly in fast-paced environments Proven ability to manage multiple projects and meet deadlines in a dynamic environment Experience collaborating on cross-functional teams

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.