Senior Legal Counsel – Global Regulatory Legal

About the position Boston Scientific is seeking a Senior Legal Counsel to join its Global Regulatory Legal team responsible for serving as legal counsel to corporate and divisional clinical, quality, and regulatory partners. Your main responsibilities will include supporting all phases of the regulated product lifecycle, including but not limited to, clinical study start-up, internal and external audits, and post-market data collection and use. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in one of the listed local offices (Arden Hills, MN; Marlborough, MA; or Valencia, CA) at least three days per week.

Responsibilities

• Evaluate legal risk and communicate effective risk assessments, including mitigation opportunities and implementation, to internal clients
• Partner with internal clients to ensure agreements and related documents are consistent with corporate policies, procedures and processes, and the desired business arrangement
• Collaborate with Business Unit, Compliance, and Intellectual Property Counsel and legal professional staff across the global Legal & Compliance Department to ensure initiatives and contracts comply with BSC policies and procedures and applicable laws
• Collaborate with internal stakeholders on content and implementation of various company policies and procedures
• Deep understanding of contract law and legal concepts, including their practical application in a business environment
• Represent and support internal clients in contract negotiations with external parties
• Support new business development by conducting due diligence and supporting integration of an acquired company's regulatory and clinical evidence generation activities
• Keep current on relevant legislative issues, laws, decisions, and regulations impacting the medical device industry Requirements
• Juris Doctorate required; active license to practice law
• 7+ years of experience, combined private practice and in-house experience, preferably with working within medical device, pharma, or healthcare industry
• Experience counseling and advising medical device, pharma, or healthcare provider clients on issues related to clinical, quality, and/or regulatory matters
• Familiarity with healthcare laws (e.g., US Anti-Kickback Statute, False Claims Act)
• Experience reviewing/revising/negotiating documents related to clinical studies (e.g., clinical study agreements, informed consent forms)
• Basic understanding of privacy and data use laws and regulations (e.g., HIPAA, GDPR)
• Ability to manage and prioritize a high-volume workload in a fast-paced working environment
• Prior exposure to regulatory requirements governing clinical trials leading to approval or clearance of medical devices for commercial use Nice-to-haves
• Ability to develop good interpersonal relationships within the Legal & Compliance Department and with cross-functional stakeholders
• Ability to interact professionally and collaborate with all levels of management, multiple geographies, internal subject matter experts, legal staff, vendors, and clients
• Excellent communication, risk-assessment, decision-making, and problem-solving skills, with ability to influence cross-functional stakeholders and decision-makers at various levels of the enterprise
• Excellent organization, facilitation, collaboration, and presentation skills
• Self-reliant with willingness to 'own' issues, drive projects, identify needs, and propose/implement solutions
• Experience engaging in internal operations projects (e.g., template development, policies)

Benefits

• Minimum

Salary: $140000

• Maximum

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