As FDA & Healthcare Regulatory Counsel you play a critical role in developing and providing timely and effective strategic legal advice to the global Siemens Healthineers organization. You would be particularly engaged within our North American (NAM) organization on all U.S. healthcare regulatory topics related to the full product lifecycle of Siemens Healthineers broad portfolio of imaging and diagnostics products, radiopharmaceuticals, therapeutic medical devices, maintenance services, consulting services, education and staffing solutions and on-premise and cloud-based software solutions. You would advise on pre-submission strategies, marketing authorizations, manufacturing and quality systems refinement and compliance, post-market reporting, advertising and promotion, as well as interaction with regulatory bodies and customers. As FDA & Healthcare Regulatory Counsel, you will report directly to the Vice President, Legal – Operational Services and Solutions and will work closely with the General Counsel – NAM and the NAM Head of Quality. As a member of the global Legal Department of Siemens Healthineers, you will also collaborate regularly with the Business Area and regional generals counsel, as well as the global lead Regulatory Counsel.
Your tasks and responsibilities:
You will provide strategic legal advice, across a diverse range of product categories and classifications, including (but not limited to) 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.
You 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.
You 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.
You 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.
You will provide counseling in connection with post-market reporting, including MDR reporting, field corrective actions, CAPA drafting, device recalls, complaint handling and similar matters.
You 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.
You 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.
You will manage regulatory legal due diligence in connection with M&A activities.
You will collaborate with sales, marketing, finance, and other departments to develop and refine regulatory and legal contract terms.
You 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.
You will develop and periodically refine and implement various corporate policies, initiatives and/or programs.
Your qualifications and experience:
You will have a minimum of 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.
You will have excellent verbal and written communication skills.
You will have an ability to calmly prioritize and execute tasks and demonstrated achievement in a fast-paced, sales-focused environment.
You will have a U.S. law degree (J.D.) required.
You will have admitted to practice law in Commonwealth of Pennsylvania (or ability to obtain Pennsylvania Limited In-House Corporate Counsel License).
Your attributes and skills:
You have 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.
You 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.
You have 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.
You have 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.
You have ability to distill and articulate such complex legal concepts into concise and plain English that business partners can both understand and readily act upon.
You have a passion for the healthcare device industry and solid understanding of its business models & strategies.
You have 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.
You have a proven ability to identify and initiate needed actions and follow-up and to find practical solutions.
You demonstrate innovation in design and delivery of legal strategies and solutions to support ever-evolving business objectives and to address emerging market expectations.
You have experience in monitoring and continually improving processes through ongoing optimization efforts, technology enhancements, and business partner feedback.
You have a Willingness and ability to travel domestically and, from time-to-time, internationally.
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