Legal Director, Global Regulatory

Additional Location(s): US-MN-Arden Hills; US-MN-Maple Grove

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:

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.

The Legal Director, Global Regulatory serves in a dual-capacity global role, providing strategic legal leadership across medical device regulatory and quality matters, as well as real-world data (RWD) and real-world evidence (RWE) initiatives.

In the primary capacity, this role provides strategic global legal counsel on medical device regulatory and quality matters, including compliance with international regulations, risk mitigation, and process development across the product life cycle. This includes advising on regulatory strategy, supporting audits and inspections, and guiding cross-functional teams to ensure adherence to evolving global standards.

In the secondary capacity, this role provides strategic legal support for RWD and RWE initiatives, partnering closely with cross-functional teams to ensure compliance, mitigate risk, and enable innovation in data-driven health care solutions.

This global role partners across regions and functions to mitigate risk, ensure compliance, and enable business strategy. The ideal candidate combines deep regulatory knowledge with strong legal acumen and operates as a strategic business partner supporting complex, high-impact initiatives.

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:

Medical device regulatory and quality support

• Serve as the legal advisor for global regulatory and quality matters impacting medical devices.
• Provide guidance on field actions, recalls, and product incident reports to ensure compliance with FDA, EU MDR, and other global regulations.
• Review and advise on corrective and preventive actions (CAPA), risk assessments, and regulatory submissions.
• Support internal investigations and ensure timely and accurate reporting to regulatory authorities worldwide.
• Collaborate with Regulatory Affairs and Quality teams to develop compliant processes for product life cycle management.
• Advise on regulatory strategy related to audits, inspections, and global compliance programs.

Real-world evidence and real-world data support

• Support RWD governance and compliance activities, ensuring adherence to applicable laws, regulations, global standards, and internal policies.
• Draft, review, and update policies, standard operating procedures, and guidance documents related to RWD and evidence generation.
• Lead legal review and negotiation of RWD and SaaS vendor agreements, ensuring appropriate data use rights and risk mitigation.
• Provide legal support to the RWD director and Corporate Medical Affairs on strategic initiatives and operational matters.

Regulatory and compliance

• Advise on FDA, EU MDR, cybersecurity laws including HITECH and SOC 2, anti-kickback statutes, FCPA, and other global regulations impacting medical devices.
• Monitor evolving laws, regulations, and guidance impacting medical devices and RWE globally.
• Deliver training and guidance to internal stakeholders on compliance-related topics.

Business partnership and risk management

• Act as a legal business partner to divisions on quality and regulatory matters.
• Identify and mitigate legal and regulatory risks, including those related to international trade and intellectual property.
• Provide proactive legal guidance and recommend process improvements to reduce regulatory risk exposure.

Required qualifications:

• Juris Doctor degree and admission to practice law in at least one US state
• Minimum of 8 years' experience in legal practice in or supporting the medical device industry
• Minimum of 2 years' experience in the regulatory and quality
• Deep understanding of FDA, EU MDR, and other global regulatory frameworks.
• Demonstrated experience advising on complex regulatory and compliance issues in a global environment.
• Excellent drafting, negotiation, and communication skills.
• Ability to manage complex projects and deliver practical, business-oriented legal advice.
• Ability to travel up to 10% globally

Preferred qualifications:

• Experience advising on real-world evidence and real-world data programs.
• Demonstrated ability to influence and build relationships across global functions.
• Strong organizational and prioritization skills in a fast-paced environment.
• High integrity and demonstrated commitment to compliance.

Requisition ID: 624806

Minimum Salary: $162400 

Maximum Salary: $308600 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.