Senior Legal Counsel - Global Regulatory Legal

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 relational 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 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)