Global Regulatory Counsel

1 week ago


Burlington NC United States Labcorp Full time

At LabCorp, you are part of a journey to accelerate life-changing healthcare breakthroughs and improve the delivery of care for all. You’ll be inspired to discover more, develop new skills and pursue career-building opportunities as we help solve some of today’s biggest health challenges around the world. Together, let’s embrace possibilities and change lives

LabCorp is searching for a Global Regulatory Compliance Attorney as a member of the LabCorp Corporate Compliance Department. This Department is committed to a trusting and collaborative culture where we value growth and development. We engage proactively with our business colleagues in maintaining the company's commitment to a strong culture of compliance.

The successful candidate will:

  • Possess working knowledge of regulatory, compliance, and other legal issues related clinical laboratories, in vitro diagnostic devices, clinical trials, and global trade, including: (1) FCPA and other anti-bribery regulations; (2) import/export compliance; (3) global trade regulations (4) FDA regulations (and other international equivalents); (5) ICH-GxP requirements; and (6) global medical device and in vitro diagnostic registration requirements
  • Provide day-to-day compliance and regulatory counseling
  • Conduct foreign third-party due diligence, including post-contract monitoring, risk evaluations and review
  • Implement and oversee compliance policy and training updates
  • Provide legal support in responding to government and client audits or investigations
  • Monitor and analyze legal and regulatory changes
  • Participate in acquisition due diligence and integration of compliance program
  • Understand and be able to clearly articulate to the business the legal ramifications of varied regulatory issues, succinctly articulate risks, and offer potential solutions
  • Be a “hands-on” attorney who is able to effectively collaborate across the organization

Education/Qualifications

Requirements

License/Certification/Education: A Juris Doctor (JD) degree from an ABA-accredited law school is required.

Education and Experience

  • JD from ABA accredited law school
  • Minimum of 1-3 years of overall experience (law firm or in-house)
  • Admission to a US State Bar
  • Anti-bribery regulations, global trade regulations, and FDA/medical device regulations experienced highly preferred
  • Solid working knowledge of laws, regulations, and industry standards (e.g. ISO 13485) that affect the development and commercialization of pharmaceutical and biotechnology products and impact a global organization
  • Team player with excellent judgment and interpersonal/communication skills
  • Ability to constructively counsel and influence clients in making the right decisions
  • Capacity to simultaneously handle a variety of complex legal matters with minimal guidance
  • Demonstrable experience taking ownership of issues and providing practical advice
  • Ability to prioritize and undertake mission critical tasks in a fast-paced environment
  • Experience in the global healthcare industry

Application Window: 10/20/2024

Hours 8am EST to 5pm EST

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here



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