Health Care - Compliance, Transactions, HIPAA Attorney in Arden Hills, MN

In-House

Arden Hills, MN

Health Care - Compliance, Transactions, HIPAA Attorney in Arden Hills, MN

Attorney

Min 7 yrs required

No

Job Title: Senior Legal Counsel - Global Regulatory Legal

Job 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 company policies and procedures and applicable laws.
- Collaborate with internal stakeholders on content and implementation of various company policies and procedures.
- Possess 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.

Education and Experience Information:
- 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 (., US Anti-Kickback Statute, False Claims Act).
- Experience reviewing/revising/negotiating documents relational to clinical studies (., clinical study agreements, informed consent forms).
- Basic understanding of privacy and data use laws and regulations (., 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 (., template development, policies).

Salary Information:
- Minimum Salary: $140,000
- Maximum Salary: $266,000
- The anticipated compensation 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. 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 (., 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, ., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Additional Information:
- The company will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
- The 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.
- 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.
- The company is committed to solving the challenges that matter most, united by a deep caring for human life. The mission is to advance science for life, transforming lives through innovative medical solutions that improve patient lives, create value for customers, and support employees and communities in which the company operates.
- The company is an equal opportunity employer. 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.
- Certain US-based positions, including field sales and service positions that call on hospitals and/or healthcare 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. The company 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. Employees are expected to meet the ongoing requirements for their roles, including any new requirements, should the company’s policies or protocols change with regard to COVID-19 vaccination.