PURPOSE AND SCOPE:The Assistant General Counsel II FDA Regulatory supports the North American medical products business working closely with FDA regulations to assist the company in obtaining FDA clearance and approval to market products and in marketing and selling such products in compliance with these regulations.This individual will be part of FMCNA’s inclusive and collegial Law Department which is comprised of nearly 60 lawyers and additional professionals working on cutting-edge legal issues across seven practice groups including Corporate Integrated Care Labor and Employment Litigation Payor Relations Regulatory and Specialty Services in support of FMCNA’s wide range of businesses.PRINCIPAL DUTIES AND RESPONSIBILITIES:
Supports the North American medical products business primarily on the US Food Drug and Cosmetic Act medical device regulations and policies including those relating to recalls promotion and advertising medical device reporting corrections and removals product approvals inspections and FDA’s quality system regulations.
Acts as a strategic legal partner to our senior managers and the medical products business in North America in substantive legal areas on issues of FDA law regulation and policy government policy and enforcement and in the compliance area.
Provides advice and counsel on various sales and marketing as well as other materials for dissemination relating to the Company and its potential products as well as respond to requests from the RA/QA teams for reviewing product labeling and liability questions.
Partners with clients’ Regulatory Affairs/Quality Assurance teams to assist and counsel in developing policies procedures product manuals legal guidance documents tools and training materials.
Works with RA/QA teams on any updates to the Medical Device Reporting database.
Assists in complying with FDA post-market requirements.
Monitors the external regulatory and enforcement environment to identify risks to the Company and its customer relationships day-to-day counseling and training of Company’s functional groups.
Updates management on regulatory developments and communicate new developments to the affected business clients.
Provides litigation support (directly or in conjunction with outside counsel) related to FDA regulatory matters.
Supports the Company as requested in interactions with regulatory authorities in North America or in interactions with other Fresenius subsidiaries internationally.
Provides legal support for compliance investigations involving issues with the FDA.
Builds and maintains relationships with key healthcare industry regulators.
Performs other Duties as assigned.
PHYSICAL DEMANDS AND WORKING CONDITIONS :
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISION:
None
EDUCATION :
Juris Doctor Degree from an ABA-accredited college or university required.
EXPERIENCE AND REQUIRED SKILLS :
Minimum of 5 years’ related experience as a practicing attorney.
Experience in healthcare regulatory compliance
Licensed to practice law in at least one U.S. state U.S. territory or Washington D.C
Strong management skills with the ability to lead cohesive and productive teams.
Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
Excellent oral and written communication skills.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender IdentityFresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws."