Description:
A Medical Equipment Manufacturing Company is a leading medical device advisory firm and clinical research organization (CRO). A Medical Equipment Manufacturing Company's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. A Medical Equipment Manufacturing Company's integrated application of these key value-creating functions provides unparalleled expertise for its clients. A Medical Equipment Manufacturing Company has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1100 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.The Assistant General Counsel will play a critical role in supporting the General Counsel in providing legal advice to support A Medical Equipment Manufacturing Company's five business value creators- regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance along with supporting the development of new business and services. This position will be responsible for handling all complex legal matters and projects and providing expert advice on A Medical Equipment Manufacturing Company's legal rights and duties.
Responsibilities and Duties:
- Draft, review, lead and negotiate business agreements, transactions, consulting agreements, clinical trial agreements, supply agreements and license agreements.
- Manage outside counsel as necessary.
- In collaboration with the General Counsel, manage disputes, litigation, and employment matters.
- Apply business and legal judgment to proposed transactions, relationships, and other legal matters.
- Analyze and advise on complex legal issues arising out of A Medical Equipment Manufacturing Company's global operations.
- Maintain a best practices corporate governance environment and protocol.
- Support the administration and maintenance of the company's compliance program.
- Research and evaluate different risk factors regarding business decisions and operations.
- Provide advice, guidance, and support in connection with corporate transactions, in collaboration with business partners.
- Collaborate with the compliance department in development and implementation of appropriate policies and training programs to support global compliance with all applicable laws, regulations, and policies.
- Ensure all work products comply fully with SOPs, regulations, standards, policies, and the mission of A Medical Equipment Manufacturing Company.
- Collaborate with other A Medical Equipment Manufacturing Company business units on business development initiatives, including proposal development and bid defenses.
- Assist with additional projects as assigned.
- 2-5 years of business/healthcare law experience at a law firm or corporate legal department is required.
- JD from an accredited law school, with requisite bar licensure in one or more U.S. jurisdictions.
- Knowledge of and experience in the medical device and/or pharmaceutical industry is required.
- Experience with FDA laws and regulations (e.g., AKS, FCPA), privacy, and compliance.
- Demonstrate the ability to manage multiple projects simultaneously in a fast-paced environment.
- Strong communication skills - both written and verbal.
- Must be a talented consensus builder and team player with the ability to engage and influence a multi-functional team.
- Must demonstrate experience identifying and resolving legal, compliance and regulatory issues quickly and effectively, with an ability to make real-time decisions.
- Demonstrated experience prioritizing conflicting demands from multiple business clients in an extremely entrepreneurial and fast-paced environment.
