Senior Legal Counsel - Global Regulatory Legal

Additional Location(s): US-MA-Marlborough; 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 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; 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 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

Required qualifications:

• 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

Preferred qualifications:

• 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)

Requisition ID: 600394

Minimum Salary: $140000 

Maximum Salary: $266000 

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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

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 identify, 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.