Navigant’s Life Sciences Disputes, Regulatory, Compliance and Investigations practice focuses on assisting corporations and their counsel in addressing the issues associated with complex disputes, investigations, regulatory and compliance, and technology services. Our disputes professionals provide expert testimony and privileged consulting on damage quantum, liability and valuation issues on complex commercial disputes. Our regulatory specialists deliver both proactive and reactive regulatory advisory services, ranging from product submissions to the FDA, to post 483 remediation. Our compliance professionals support clients through the development, implementation and evaluation of healthcare compliance programs. They also act as monitors in Independent Review Organization roles, support the implementation of Corporate Integrity Agreements and support Compliance Officers and Boards in an advisory capacity.
Our investigations professionals provide privileged and independent consulting on complex issues related to the False Claims Act, Anti-kickback Statute, the Physicians Payments Sunshine Act and the Food, Drug and Cosmetics Act, which may result in expert testimony and reporting to management, boards and regulators on accounting disputes, auditor malpractice and individual white- collar defense. In global investigations, we combine deep investigative law enforcement, industry and accounting skills on anti-money laundering, bribery & corruption, public sector & monitoring, healthcare and government contracting compliance & investigative matters, including discovery services, compliance technology and complex data management.
We deliver technology services to assist in the litigation and investigation process and in solving business problems practice areas and have technology platforms established related to compliance needs, such as compliance program effectiveness and reporting, Open Payment reporting and Arrangements Databases supporting interactions between the industry and Healthcare Professionals.
- Assists clients in establishing quality systems that comply with 21 CFR Parts 11, 50, 56, 58, 803, 820, ISO 13485 and ISO 14971.
- Makes recommendations to client on how to comply with above referenced regulations and standards, including development of standard operating procedures. Proposes creative solutions to client issues.
- Conducts audits of clients’ quality systems to assess compliance with above referenced regulations and standards.
- Skillfully writes audit reports and tactfully presents findings to clients.
- Assists clients in inspection preparation and responses to inspection observations.
- Conducts client training on topics as requested, including good manufacturing practices and inspection readiness.
- Assists diligence reviews of manufacturing process in mergers/acquisitions.
- Assists in the drafting and review of regulatory submissions, including IDE, Q-sub, 510(k), De Novo Requests, and PMA submissions.
- Supports team in the management of day-to-day client relationships and expectations.
- Builds client relationships and looks for opportunities to expand projects.
- Works to produce “client ready” deliverables.
- Assists with writing proposals and client pitches.
- 5 to 8 years’ industry or government experience in conducting review, audit, or inspections of FDA-regulated products. Experience working with the FDA's Center for Devices and Radiological Health preferred
- Medical device and/or in vitro diagnostic experience required
- Bachelor Degree in Life Sciences, Engineering, or Computer Science from an accredited college or university. MS or PhD in a similar discipline preferred.
- Understanding of, and ability to analyze and apply regulations and standards related to the Food, Drug, and Cosmetic Act.
- Prior experience in software design, engineering, or testing is preferred.
- Prior experience in assessing or implementing cybersecurity requirements and technical frameworks (i.e. NIST Cybersecurity Framework) is preferred.
- Strong written and oral communication skills.
- Proficient in Excel, Word, and PowerPoint skills and ability to independently produce documents or aptitude to develop this level of skill within a defined period.
- Self-directed and independent with the ability to perform with minimal direct supervision.
- Frequently communicates with clients and coworkers and must be able to share information effectively
- Strong conceptual, as well as quantitative and qualitative analytical skills
- Work as a member of a team as well as be a self-motivator with ability to work independently
- Flexibility and responsiveness in managing multiple projects in sometimes high-pressure situations simultaneously
- Able to travel via airplane with minimal assistance to client sites across the US and potentially internationally
- Usually remains stationary for the majority of the day
- Regularly uses close visual acuity and operates computer equipment to prepare and analyze and transmit data