Associate Vice President Regulatory & Healthcare Compliance Counsel

Associate Vice President Regulatory & Healthcare Compliance Counsel

Requirements

• 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.

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.

Preferred Qualifications

No preferred qualifications provided.