Legal Director, Global Regulatory

bostonscientific•Maple Grove, MN

3h•$162,400 - $308,600•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.