Job Details

FDA & Healthcare Regulatory Lead Counsel

Company name

Siemens Healthineers

Organization Type

In-House

Job Type

Attorney

Date Last Verified

Feb 17, 2020

Valid Through

Jun 01, 2020

Posted on

Sep 24, 2019

Years of Experience

Min 15 yrs required

Location

Malvern, PA, United States

Employment Type

Full-time

Industry

Legal
Practice Area
Food & Drug Administration >> Food & Drug Administration
Government and Government Relations >> Government and Government Relations
Health Care >> Health Care
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FDA & Healthcare Regulatory Lead Counsel
Duties: Will provide strategic legal advice, across a diverse range of product categories and classifications, including diagnostic medical devices, both in vitro and in vivo; Laboratory Developed Tests (LDTs); Investigational Use Only (IUO) products; Research Use Only (RUO) products; Forensic Use Only (FUO) products; medical software and health information systems used for diagnostic applications; companion diagnostics and personalized medicine products; combination products; and digital health product offerings. Will provide advice and guidance regarding FDA device regulation throughout the full lifecycle of products, including R&D; development strategies, including with respect to clinical trial design and regulatory pathways; regulatory strategy and pre-market applications (including for digital health and other combination products); premarket notifications, including 510(k)s and PMAs; manufacturing; post-market (including any product modifications) and product end-of life. Will advise on the development, revision, review and approval of product advertising, labeling, other promotional materials including social media and internet content, alleged Lanham Act violations or unfair trade practices, and scientific exchange. Will guide and shape FDA and state inspection preparedness, as well as responses to, and remediation related to, Form 483 observations and related FDA letters and comparable state regulatory activities. Will provide counseling in connection with post-market reporting, including MDR reporting, field corrective actions, CAPA drafting, device recalls, complaint handling and similar matters. Will actively counsel business partners and other attorneys regarding the Anti-Kickback Statute and its safe harbors; the False Claims Act; physician self-referral law (Stark); health care services reimbursement and value-based purchasing; and related topics. Will inform and shape advocacy before Congress, FDA, and other federal and state bodies and agencies with respect to existing and/or emerging regulatory policies. Will manage regulatory legal due diligence in connection with M&A activities. Will collaborate with sales, marketing, finance, and other departments to develop and refine regulatory and legal contract terms. Will support corporate compliance through the development and implementation of policies and procedures, as well as trainings of sales, marketing, legal, field finance and other personnel on regulatory matters and other relevant topics. Will develop and periodically refine and implement various corporate policies, initiatives and/or programs.

Qualification and Experience

Qualifications: Will have a U.S. law degree (JD Degree) required. Will have 15+ years of FDA regulatory legal experience in a well-regarded healthcare-recognized law firm, in FDA and/or the in-house legal department of a leading healthcare company; significant in-house experience a strong plus, especially within a publicly-listed company. Will have excellent verbal and written communication skills. Will have an ability to calmly prioritize and execute tasks and demonstrated achievement in a fast-paced, sales-focused environment. Will have admitted to practice law in Commonwealth of Pennsylvania (or ability to obtain Pennsylvania Limited In-House Corporate Counsel License). A proven ability to independently lead and execute all facets of challenging and intricate engagements and do so with highest integrity and ethics and in real-time. Are highly polished and effective within negotiation, communication, listening and drafting skills, including those suitable for interaction with senior managers and executive leadership within a global and matrixed organization and with senior management of key customers. A deep expertise in u.s. federal & state healthcare legal and regulatory environments, including advertising and promotion, product claims, manufacturing processes, quality systems, sales and distribution. Fluency with the various healthcare laws and regulations, including anti-kickback laws, fraud and abuse statutes, and privacy laws applicable to medical device manufacturers and pharmaceutical companies, as well as those applicable to their respective customers. Ability to distill and articulate such complex legal concepts into concise and plain english that business partners can both understand and readily act upon. A passion for the healthcare device industry and solid understanding of its business models & strategies. A proven skill in influencing change and building cooperation across corporate business units and departments and throughout a large group of affiliated companies to timely achieve optimized results while minimizing risk. Demonstrated skill in working collaboratively and efficiently in a complex, matrixed and fast-paced environment and with multiple teams simultaneously, some of whom may be outside of the u.s. A proven ability to identify and initiate needed actions and follow-up and to find practical solutions. Demonstrate innovation in design and delivery of legal strategies and solutions to support ever-evolving business objectives and to address emerging market expectations. Experience in monitoring and continually improving processes through ongoing optimization efforts, technology enhancements, and business partner feedback. A willingness and ability to travel domestically and, from time-to-time, internationally.

Additional info

Ref. 180664

Company info

Hiring Coordinator
Siemens Healthineers
40 Liberty Blvd
Malvern, PA 19355

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