Associate Vice President Regulatory & Healthcare Compliance Counsel

This role seeks an experienced attorney who is able to provide proactive guidance and counseling related to global and US regulatory, quality, safety, clinical and medical activities with an eye towards minimizing company legal exposure and ensuring continuous compliance. The role is focused on using legal and regulatory frameworks, based on legal interpretation of applicable laws and regulations, to maximize business opportunities and build relationships of trust with US and global regulators, including FDA. The ideal candidate will excel in fostering trusted partnerships with the Global Quality and Regulatory Affairs team to collaboratively address these topics.

As part of the Agilent Legal Team, the AVP, Regulatory & Healthcare Compliance will bring an expert understanding of the life sciences industry and the legal implications of Company initiatives and strategies. The incumbent will be a big-picture thinker who is able to anticipate changes in law, environment, and Company objectives and manage and mitigate risk accordingly. In order to be effective, AVP, Regulatory & Healthcare Compliance will maintain familiarity with laws that affect areas of Agilent's operations, including those relevant to good clinical and manufacturing practices, sales and marketing of products to health care professionals, and reimbursement by government programs, including, for example, fraud and abuse (Anti-Kickback Statute, False Claims Act), FDA regulation (Food, Drug & Cosmetic Act), CLIA, privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act).

Successful AVP, Regulatory & Healthcare Compliance candidate will have exceptional business counseling gravitas and, having built strong, trusting relationships with business partners, is able to influence and guide multi-functional teams to achieve optimal business outcomes.

Key Responsibilities

• Partner to Global Quality and Regulatory Affairs (GQRA), and the Office of the Chief Medical Officer (OCMO) to assist and counsel in developing policies, procedures, product manuals, legal guidance documents, tools, and training materials.
• Partners with GQRA to monitor 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 communicates new developments to the affected business clients.
• Assists the business in meeting clinical and commercial goals with appropriate legal and business oversight.
• Collaborates with other attorneys in the Legal Department who provide counsel and guidance to the Company's research and development groups with respect to all applicable business conduct, regulatory, and health and safety laws, statutes, rules and regulations, and guidelines, including but not limited to regulations and guidance governing the conduct of clinical research and the protections of human subjects.
• Partners with GQRA, OCMO and other functional areas to develop, implement, and provide guidance on Agilent's healthcare compliance policies, ensuring adherence to global healthcare regulations and standards.
• Provides guidance on regulatory compliance as required in areas related to the use and distribution of chemicals and dangerous goods.
• Provides support on audits and risk assessments, overseeing the implementation of appropriate safeguards to mitigate identified risks.
• Develops and delivers training programs to educate employees on regulatory compliance and ethical practices.
• Fosters a culture of compliance and ethical awareness across the organization, promoting a proactive approach to regulatory governance.
• Supports the Company, as requested, in interactions with regulatory authorities in North America and internationally.
• Partners with GQRA to build and maintain relationships with key healthcare industry regulators.
• Provides legal support for inspections and compliance investigations involving issues with regulatory authorities, including the FDA.
• Provides legal support to GQRA and OCMO as required to review SOPs related to Adverse Event Reporting, complaint handling, and corrective actions with an eye towards continuous compliance and enhancements.
• Counsels on the handling of legal and reporting aspects related to regulatory inspections, signal detection, and assessment.
• Additional representative responsibilities for this role:
  • Review and provide input over regulatory communications.
  • Counsel on quality agreements.
  • Provide guidance on the application of applicable legislation to digital solutions that may be classified as medical devices.
  • Advise on go-to-market strategy and messaging for healthcare and patient communications for high risk / high visibility products (first to market, highly innovative, products subject to litigation, etc.).
  • Provide Legal support for Medical and Scientific Affairs Activities.
  • Consult and collaborate in the area of Policy Monitoring through external agencies such as PhRMA, AdvaMed and FDLI.
  • Review SOPs related to advertising and promotion processes and trends etc. from a US perspective.
  • Consult on the appropriate regulatory framework and application type for individual products.
  • Partner with GQRA on timely communication with regulators about data changes, format styles, and the necessity of new or updated filings.
  • Provide thought leadership on the impact of current regulatory communications and actions upon future legal liability to patients or hospitals.

• J.D. from an accredited U.S. law school.
• Must be licensed to practice law in at least one U.S. jurisdiction.
• Minimum of 10 years of combined relevant experience as an attorney at a law firm, company, and/or government focusing the areas of practice on US and global regulations governing medical device, diagnostics and pharmaceutical regulations.
• Experience & demonstrated ability to collaborate, build and sustain effective partnerships with multicultural key stakeholders and project teams.

Additional Details