Job Description
Assist in the management of corporate legal matters domestically and internationally for a globally focused, high growth, medical device company. Tasks include strategic legal counseling, litigation management, contract negotiations and drafting, and providing advice and counsel on legal issues related to the regulatory and compliance framework applicable in the medical device industry (FDA, ADVAMED, FCPA, etc.). Provide legal advice to the headquarters and to the various business functions internationally, including HR, Sales, Procurement, Clinical, Quality and Regulatory. Negotiate corporate transactions and prepare related documentation. Must be able to perform legal assignments with a high degree of independence requiring extensive experience, skill, and knowledge. Perform legal work, conduct research, and provide legal support and counsel to various functions. Assume primary responsibility for protecting the company against legal risks associated with clinical and regulatory matters. Opportunity for leadership and management. Job duties:
- Ability to be onsite 3 days a week
- Draft, review, negotiate, and amend complex agreements in support of the company’s clinical development programs, procurement, and other business matters.
- Negotiate with sophisticated counterparties, such as hospitals, teaching institutions, and clinical research organizations.
- Assist in the management of commercial, employment, and product liability litigation matters.
- Advise and counsel on corporate, regulatory, litigation, and other business matters.
- Draft and negotiate various commercial contracts such as sales and service agreements, consulting agreements, distribution agreements, etc.
- Support and advise the company’s Clinical Research and Compliance teams and other business units.
- Anticipate internal/external business and regulatory issues and provide applicable legal advice.
- Advise and consult with stakeholders to identify critical legal issues and assess potential legal options and business risk mitigations.
- Closely align with other members of the Legal department and client groups to provide consistent advice across the company.
- Assist with the continuous development and improvement of the Legal Affairs team and its processes.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Complete special projects as requested and perform additional duties as assigned.
Qualifications
- JD from an ABA accredited law school.
- Minimum of seven to ten (7-10) years of relevant in-house experience.
- Ability to effectively collaborate and demonstrate broad business and sound legal judgment.
- Capable of working independently and as part of a team.
- Highly developed interpersonal and leadership skills.
- Excellent verbal and written communication skills.
- Proficiency with MS Office Suite with emphasis on Word, Excel, PowerPoint, and Outlook, Adobe, and OneDrive.
Desired Qualifications
- Current California Bar membership in good standing preferred; will consider qualified in-house California counsel.
- Medical device, pharmaceutical or other healthcare-related experience with a focus in clinical trials, regulatory, compliance and related subject matter highly desirable.
- Background in employment counseling and litigation.
- Combination of law firm and in-house experience.
- Effective management of outside counsel.
- Trusted advisor and business partner.
- Prior management experience.
- Experience with Legal Operations and desire to lead the department in adoption of processes and systems to streamline and create efficiencies.