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General Counsel
Consulting
provided
exceptional
service in helping
my organization
recruit for a hard
to fill position.
They did extensive
work on the front
end to understand
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highly qualified
candidates almost
immediately.

Melinda Burrows
Deputy General Counsel
- Litigation and
Compliance, Progress
Energy Service Company
LLC

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Counsel Jobs > Senior Corporate Counsel, Regulatory (FDA) Job in Illinois > Senior Corporate Counsel, Regulatory (FDA)

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Senior Corporate Counsel, Regulatory (FDA)

Refer job# SPVZ140948

Senior Corporate Counsel, Regulatory (FDA) - 18123588 Hill-Rom is a $2.7B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hill-Rom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care. Description The Role Hill-Rom seeks to bring FDA regulatory expertise in-house. In this new role, the Senior Corporate Counsel, Regulatory provides advice and counsel to Hill-Rom s three Global Business Units ( GBUs ) and to the Quality & Regulatory Affairs function, regarding conducting business in conformance with applicable laws and regulations governing the manufacture, sale & distribution of medical devices, primarily FDA regulations. By establishing this practice, s/he will provide advisory services impacting new product strategies, export controls, etc. Reporting Relationships The Senior Corporate Counsel, Regulatory (FDA) is an individual contributor, Director level role reporting to the Vice President Associate General Counsel. S/he will be peers of the Senior Corporate Counsel, Employment, the Senior Corporate Counsel, Intellectual Property and the Senior Corporate Counsel, Regulatory (focused outside of US). Basic Function and Principal Responsibilities - Supports, counsels and provides guidance to GBU Regulatory leads on all interactions with regulatory authorities (primarily the FDA). - Partners with and supports peer commercial and IP lawyers to structure commercial transactions including partnerships, licensing arrangements, joint development agreements, and M&A transactions to ensure compliance with applicable medical device regulations. - Performs all due diligence on regulatory matters in M&A transactions. - Develops and delivers training on legal requirements to the GBUs and the quality and regulatory affairs department on applicable regulations. - Keeps apprised of regulatory changes impacting the Company and its product offerings and communicates regularly with GBU leaders and legal department colleagues thereon; participates in Advamed activities relating to regulatory issues impacting the Company and its products. - Advises on proactive measures and approaches for ensuring compliance with applicable regulations. - Regularly reviews and updates internal processes and programs in QA/RA function to ensure compliance and best practice. - Advises on the development, maintenance, and distribution of promotional and other materials used in connection with the sale and promotion of the Company s products. - Other duties may be assigned. - Expected Travel: 20%. Location The role is located at our global corporate headquarters in downtown Chicago. Candidates residing in the Washington DC area will also be considered. In either instance, local candidates are preferred (no relocation). Qualifications Education and Experience - J.D. from accredited law school. - 8-15 years FDA legal experience is required (any combination of large law firm, government, in-house). - Working in-house at large company doing FDA work is highly preferred; industries could include medical devices, pharmaceuticals, food production, etc. - Global regulatory experience on top of the required FDA is a plus. - Demonstrated experience in counseling business on compliance with FDA regulations and interacting with the FDA on behalf of clients. - Experience with US regulations related to the marketing, advertising, and promotion of medical devices, strongly preferred. - Excellent communication and leadership skills. Hill-Rom is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity #INDHR Job: Legal Advisor Primary Location: United States-Illinois-Chicago, IL Schedule: Full-time Travel: Yes, 10 % of the Time Posting Entity: Hill-Rom

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