Senior Legal Counsel - Global Regulatory Legal

Senior Legal Counsel - Global Regulatory Legal Onsite Location(s) : Marlborough, MA, US, 01752Additional Location(s) : US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 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.This role follows a hybrid work model requiring employees to be in one of the listed local offices (Arden Hills, MN; Maple Grove, MN; or Marlborough, MA) at least three days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities will include : Evaluate legal risk and communicate effective risk assessments, including mitigation opportunities and implementation, to internal clientsPartner with internal clients to ensure agreements and related documents are consistent with corporate policies, procedures, and processes, and the desired business arrangementCollaborate 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 lawsCollaborate with internal stakeholders on content and implementation of various company policies and proceduresDeep understanding of contract law and legal concepts, including their practical application in a business environmentRepresent and support internal clients in contract negotiations with external partiesSupport new business development by conducting due diligence and supporting integration of an acquired company’s regulatory and clinical evidence generation activitiesKeep current on relevant legislative issues, laws, decisions, and regulations impacting the medical device industryRequired qualifications : Juris Doctorate required; active license to practice law7 years of experience, combined private practice and in-house experience, preferably with working within medical device, pharma, or healthcare industryExperience counseling and advising medical device, pharma, or healthcare provider clients on issues related to clinical, quality, and / or regulatory mattersFamiliarity 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 environmentPrior exposure to regulatory requirements governing clinical trials leading to approval or clearance of medical devices for commercial usePreferred qualifications : Ability to develop good interpersonal relationships within the Legal & Compliance Department and with cross-functional stakeholdersAbility to interact professionally and collaborate with all levels of management, multiple geographies, internal subject matter experts, legal staff, vendors, and clientsExcellent communication, risk-assessment, decision-making, and problem-solving skills, with ability to influence cross-functional stakeholders and decision-makers at various levels of the enterpriseExcellent organization, facilitation, collaboration, and presentation skillsSelf-reliant with willingness to “own” issues, drive projects, identify needs, and propose / implement solutionsRequisition ID : 600394Minimum Salary : $140,000Maximum Salary : $266,000The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) 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 Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.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.#J-18808-Ljbffr

Salary : $140,000 - $266,000