Newly created role at MedTech company w/ recent approval and growing exponentially!
This Jobot Job is hosted by: David Montgomery
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
A bit about us:
Our client is rapidly growing MedTech company making breakthroughs and ultimately improving and saving millions of lives.
Why join us?
This is a great opportunity to build something internationally, and be on the ground floor of a team that will grow rapidly over the next few years. You will be challenged in ways that are hard to find elsewhere.
This position will be instrumental in advancing the company’s strategic initiatives. The Corporate Counsel will provide legal support
in areas such as drafting and negotiating a wide variety of contracts, managing the workflow of the contracting process, supporting business development and licensing. The ideal candidate will be looking to build on existing strengths, in one or more of these areas, to quickly develop a broad range of legal and business expertise to support a growing Medical Device company.
Responsibilities and Duties
- Act as primary contact within the organization for legal activities. This will include drafting, reviewing, and negotiating a wide range of commercial agreements to meet business and legal requirements, including supply, sales, licensing, distribution, quality, research and development, commercialization, nondisclosure, and employment agreements.
- Manage legal aspects of corporate compliance including Stark Law, Anti-Kickback Statute, Federal False Claims Act, global privacy laws and state and country specific rules and regulations.
- Advise and work with external and internal institutional review boards and draft and review clinical trial agreements, study protocols and informed consents.
- Collaborate with R&D, logistics, supply chain management, sales, marketing, finance, intellectual property, regulatory affairs, compliance, and other departments to analyze and further business, regulatory and legal imperatives.
- Provide training, education, and counseling on best practices for third party agreements, commercial law, competition, regulatory matters, corporate policies, initiatives and programs, and other relevant topics.
- Prepare user-friendly visuals, legal templates, policies, procedures, guidance documents, tools and training materials.
- Advise and keep abreast of changes in laws and regulations globally that may affect the medical device industry.
- Perform legal research and assist in other legal matters as and when required.
- Develop creative and compliant solutions to assist in structuring and resolving complicated business challenges.
- Negotiate with key customers, partners, suppliers, vendors, and government agencies.
- Minimum of 10 years of transactional experience drafting and negotiating complex commercial, licensing, development, consulting, service, research, and clinical trials agreements in medical device setting. Must include some in-house corporate experience.
- U.S. law degree (J.D.) required.
- Admitted as a member in good standing of the state of California Bar.
- Fluency with the regulatory environments, including FDA regulations, anti-kickback laws, fraud and abuse statutes, and privacy laws applicable to medical device manufacturers.
- Familiarity with key elements of procurement, manufacturing, logistics, licensing, data privacy, compliance, intellectual property and distribution legal issues.
- Highly polished and effective negotiation, communication, listening and drafting skills.
- Must be responsive and pro-active and able to effectively multi-task and handle a variety of matters with competing priorities.
- Demonstrated skill in working collaboratively with multiple business associates, departments, and teams simultaneously and effectively and coordinating with multi-jurisdictional and multi-cultural transaction partners.
Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.