Principal Regulatory Affairs Specialist

About the role:

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

We are seeking a Principal Regulatory Affairs Specialist to lead regulatory strategy and lifecycle management for an integrated hepatic artery infusion therapy portfolio within the Interventional Oncology and Embolization division. This portfolio includes both pharmaceutical and implantable medical devices, creating a unique opportunity to work across regulatory frameworks supporting a differentiated therapy platform.

In this role, you will provide regulatory leadership for products operating within a hybrid regulatory model. You will support Boston Scientific’s responsibilities as a private label distributor and virtual manufacturer for the drug product while serving as the legal manufacturer for the associated medical device system.

You will collaborate closely with internal teams and external partners to integrate products into Boston Scientific quality systems, manage lifecycle changes, maintain regulatory compliance, and enable global expansion through proactive regulatory planning and health authority engagement.

This role contributes to advancing innovative interventional oncology therapies designed to expand treatment options for patients with complex liver cancers.

The ideal candidate brings deep regulatory experience in pharmaceutical, medical device, or combination products and thrives in a collaborative, cross-functional environment supporting complex global regulatory strategies.

Work model, sponsorship:

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. 

Your responsibilities will include:

Drug product regulatory support (private label distribution/virtual manufacturing):

● Serve as the regulatory affairs point of contact for Boston Scientific’s responsibilities as a private label distributor and virtual manufacturer, partnering with the contract manufacturing organization (CMO) to enable compliant supply, distribution, and lifecycle execution.

● Coordinate regulatory assessments and determine Boston Scientific impact for proposed changes to product, process, analytical methods, packaging, labeling, or manufacturing sites initiated by the CMO.

● Support internal change control and integration of the drug product into Boston Scientific quality and regulatory processes, including alignment with external partner quality systems.

● Partner with Quality, Supply Chain, and Operations to support inspection readiness and audit responses related to Boston Scientific responsibilities and CMO interfaces.

● Provide regulatory input for issues impacting supply, including quality events, complaint trends, field actions, or shortages.

● Support global expansion initiatives by coordinating with regional regulatory teams and external partners on registration strategy, submission responsibilities, and post-market maintenance activities.

Medical device regulatory leadership (legal manufacturer responsibilities):

● Represent Regulatory Affairs on cross-functional teams supporting new product development and sustaining activities, including manufacturing changes, site transfers, supplier changes, and continuous improvement initiatives.

● Lead development and execution of U.S. and EU regulatory strategies for Class II and Class III medical devices, including lifecycle submission planning and proactive agency engagement.

● Prepare, coordinate, and compile regulatory submissions, including PMA supplements, 510(k)s, EU MDR technical documentation updates, and pre-submissions.

● Evaluate device design, manufacturing, and supplier changes for regulatory impact and ensure compliant updates to regulatory filings and technical documentation.

● Lead and support interactions with the U.S. FDA and EU notified bodies to secure and maintain regulatory approvals.

● Partner with international regulatory teams and external partners to support OUS registrations and post-market regulatory activities.

Regulatory execution and cross-functional leadership:

● Translate regulatory requirements into cross-functional plans and communicate expectations to achieve business-aligned outcomes.

● Apply project management and technical writing expertise to drive regulatory deliverables across multiple initiatives.

● Build strong partnerships across functions, including R&D, Quality, Operations, Supply Chain, Clinical, and Medical teams, as well as external partners, to identify risks, remove barriers, and support execution.

Required qualifications:

● Bachelor’s degree in a scientific or technical discipline, such as pharmacy, chemistry, biology, engineering, or biomedical sciences.

● Minimum of 7 years' experience in regulatory affairs, or minimum of 5 years' experience with an advanced degree (master’s or PhD) in a related discipline.

● Experience supporting marketed healthcare products within the pharmaceutical, biotechnology, medical device, or combination product industry.

● Experience supporting post-approval lifecycle management activities, including regulatory change impact assessments and cross-functional implementation planning.

● Experience working with external partners, such as contract manufacturing organizations, development partners, or regulatory consultants.

● Working knowledge of global regulatory frameworks, including FDA and/or EU regulatory requirements.

● Experience preparing or supporting regulatory submissions to health authorities.

● Proficiency in Microsoft Office.

Preferred qualifications:

● Experience supporting pharmaceutical products in a private label distributor, virtual manufacturing, or partner-led regulatory model.

● Experience supporting products where the MAH, NDA, or ANDA owner is external.

● Direct medical device regulatory experience with Class II or Class III products and lifecycle submissions, including PMA supplements, IDEs, 510(k)s, or EU MDR technical documentation updates.

● Experience supporting integrated therapies, combination products, or drug-device interface products.

● Experience engaging with the FDA or EU notified bodies, including briefing package development, response drafting, and regulatory strategy support.

● Experience submitting regulatory filings to the FDA, EU notified bodies under MDR, or other global regulatory agencies.

● Experience supporting global registrations or OUS expansion and coordinating with regional regulatory partners or consultants.

● Experience working effectively in a matrixed environment and collaborating across cross-functional teams.

● Strong technical writing, communication, and project management skills.

● Demonstrated ability to manage multiple projects and priorities effectively.

● Ability to work independently and adapt in a dynamic regulatory environment.

● Strong problem-solving mindset with a focus on quality, results, and timely delivery.

#LI-Hybrid