Corporate Counsel – Medical Device

Job Description

Corporate Counsel – Medical Device, Regulatory and Compliance

Our well-established, and growing client is looking for a business-minded attorney, with experience in the medical device field primarily focused on regulatory, clinical and/or compliance matters. Areas of focus would include advertising and promotion, support to clinical and regulatory functions in the research and development of the company’s products, and a variety of healthcare compliance matters (e.g., federal and state fraud and abuse laws). The candidate will work under the direction of the General Counsel and work closely with other internal business teams and leadership across the company.

The ideal candidate is a self-motivated attorney who excels at identifying risk, problem solving, and partnering with the business to make decisions amidst ambiguity.

Responsibilities:

• Provide legal counsel and guidance to the company’s internal business teams on a wide range of legal issues related to development and commercialization of a medical device, including regulatory issues, clinical research, advertising and promotion, data privacy and security, and healthcare fraud and abuse.
• Counsel on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, and government entities.
• Participate in a multidisciplinary committee to review promotional, marketing, advertising and training materials.
• Assist in negotiation, drafting, and review contracts across the organization, including with the company’s vendors, consultants, clinicians, and other 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.
• As needed, conduct or support internal investigations raised through the company’s compliance programs.

Requirements:

• JD from an accredited law school, with requisite bar licensure in one or more U.S. jurisdictions, preferably including Pennsylvania.
• A minimum of 5-7 years of experience, preferably with some combination of law-firm and in-house experience in the medical device, pharmaceutical or biotechnology industries.
• Broad knowledge, and preferably expertise, in a wide array of legal areas relating to the development and commercialization of a medical device, including the U.S. Food, Drug and Cosmetic Act and related regulations, and U.S. healthcare fraud and abuse laws, including the federal False Claims Act and the Anti-Kickback Statute, as well as up-to-date familiarity with guidance and enforcement priorities of government enforcement and regulatory agencies.
• Exceptional written and verbal communication skills.
• Strong negotiation and drafting, communication, administrative, and time management skills.
• Ability to build strong relationships cross-functionally, including with stakeholders across clinical, regulatory, commercial and medical education disciplines.
• Ability to exercise sound judgment and operate under pressure.
• Willingness to assume multiple functions with shifting priorities and work on projects of all types.
• Thrives in a fast-paced, constantly evolving and growing environment and seeks to work in a collaborative framework.
• Desire and ability to operate independently with autonomy within a small legal department.