Closing Date: 16th May, 2025

Description:

A Healthcare Company is searching for a Global Regulatory Compliance Attorney as a member of the A Healthcare Company 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.

Due to this role supporting clients based on the East Coast and in Europe, we are prioritizing applications from individuals currently located within US Central and East Coast time zones.

Responsibilities:

Possess working knowledge of regulatory, compliance, and other legal issues related clinical laboratories, in vitro diagnostic devices, clinical trials, and global trade, including: (1) FDA regulations (and other international equivalents); (2) ICH-GxP requirements; (3) global medical device and in vitro diagnostic registration requirements; (4) FCPA and other anti-bribery regulations; (5) import/export compliance; and (6) global trade regulations Provide day-to-day compliance and regulatory counseling
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
Conduct foreign third-party due diligence, including post-contract monitoring, risk evaluations and review
Be a “hands-on” attorney who can effectively collaborate across the organization

Requirements:

License/Certification/Education: A Juris Doctor (JD) degree from an ABA-accredited law school is required.
Minimum of 2 years+ of overall experience (law firm or in-house) is required
Admission to a US State Bar is required
Experience in the global healthcare industry is required
Global experience is preferred
FDA/medical device regulations, Anti-bribery regulations, and global trade 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 is preferred
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