Description:

Job Description Summary:
The Senior Counsel, Regulatory will be responsible for providing strategic legal support regarding global quality and regulatory matters associated with manufacturing, distribution, and sale of medical devices and pharmaceuticals. The Senior Counsel, Regulatory will work closely with global Quality and Regulatory partners, Legal and Compliance partners, and other cross-functional partners to facilitate An American Multinational Conglomerate Company's vision and strategy, support regulatory compliance, and mitigate risk. This role will include advising on a wide array of quality and regulatory topics across An American Multinational Conglomerate Company products, businesses, and regions. Particular areas of focus will include pharmaceutical regulation, advertising and promotion, and business development initiatives. This role could be located anywhere within the U.S.

An American Multinational Conglomerate Company is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description:
Essential Responsibilities:
The Senior Counsel, Regulatory will be part of a small Global Legal-Regulatory team providing counsel to the An American Multinational Conglomerate Company Quality and Regulatory Organization.

Responsibilities for the role of Senior Counsel, Regulatory will include:

Provide legal guidance regarding FDA regulations and other global regulations relating to pharmaceutical and medical device products, including pre-market and post-market quality and regulatory requirements.
Advise as needed on FDA regulations and other global regulatory requirements in the context of business development activities.
Advise on advertising and promotion matters related to pharmaceuticals and medical devices. Work collectively with Regulatory, Legal and Compliance colleagues in the development and implementation of policies, procedures, legal guidance documents, and training materials in certain key areas of regulation including advertising and promotion materials and other external communications.
Engage with cross-functional colleagues, including Quality & Regulatory, to identify and advise in areas of new and emerging law related to regulation of medical device and pharmaceutical products.
Partner with Quality & Regulatory colleagues to help develop and finalize responses to audit / inspection findings.
Assist in due diligence of GEHC potential acquisitions and potential remediation/integration activities after acquisition.

Qualifications/Requirements:

Juris Doctor (or Ex-US equivalent) with active bar membership/license.
7 years of healthcare regulatory legal experience, with focus on U.S. Federal Food, Drug, and Cosmetic Act at a large law firm, government agency, and/or corporate legal department, including focus on pharmaceutical regulations.

Desired Characteristics:

A strong commitment to integrity and professionalism, solid judgment and a passion for excellence.
Strong analytical skills and verbal/written communication skills.
Ability to provide thoughtful and clear counsel to a variety of stakeholders on complex matters of law and regulation, distilling high-volume and complex information into salient and relevant points.
Effective interpersonal skills, mature judgment, and independent thinking, with ability to interact across functions and at all levels of an organization with clarity, objectivity, candor, and transparency.
Ability to identify and resolve legal issues in a fast-paced environment.
Willingness to work collaboratively with a high degree of engagement and contribution.
Ability to prioritize while managing conflicting demands from multiple stakeholders.
Problem-solving mindset.
High level of cultural sensitivity, flexibility, and emotional intelligence to work effectively across a global, multicultural environment.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.