Counsel, Regulatory & Compliance (Hybrid)

Description:

A Manufacturer Company is looking for an attorney to work closely with its global business leaders and managers in providing practical business advice on healthcare product regulations and compliance, GDPR, as well as a wide range of other compliance and regulatory issues. The position is perfect for an attorney seeking to expand their experience in a broad range of regulatory and commercial issues, working with businesses based in the US, Mexico, Brazil, Europe, Asia and India and wishes to have direct interaction with clients on a day-to-day basis. You will be working directly for the General Counsel and with the other members of our legal department.
The ideal candidate will be smart, resourceful, interested in learning the business, and a problem solver. Our work is diverse and varied, so if you enjoy learning new things and can gather and assess facts and legal issues quickly and bring your informed judgment to critical business decisions, this is your job!
Key Responsibilities:

• Providing practical regulatory guidance on federal, state, and local laws and applicable regulations for a wide variety of domestic and international issues.
• Researching the impact of proposed and new rules, regulations, and legislation and advising the SDS leadership on appropriate mitigation strategies and/or response.
• Anticipating and identifying legal and regulatory risks and proposing strategic, creative, and effective solutions to address those risks.
• Special focus on analyzing healthcare product manufacturing laws and regulations, including but not limited to Good Manufacturing Practices, and providing guidance to SDS leaders to implement and maintain a strong compliance environment.
• Working cross-functionally with business and operations teams to build and maintain robust processes that ensure compliance with regulatory requirements.
• Manage incoming regulatory and governmental requests, including responding to audits and inquiries.
• Working cross-functionally to support other Legal Team members.
• drafting, reviewing, advising, and assisting with the negotiation of a broad range of domestic and international transactions, including, but not limited to, supply agreements, service agreements, , purchase agreements, agent/distributor agreements, and confidentiality agreements.
• Supporting labor and employment, internal investigations, and general litigation.
• Assisting with the development of commercial and compliance policies and processes.
• Managing and working with outside counsel.
• Creating and delivering training on commercial, compliance, and regulatory issues.
• Owning discrete legal initiatives and projects as they arise based upon changing business priorities.
• Performing other duties as assigned or required.

Qualifications:

• JD from an ABA accredited law school and active license and membership in good standing with at least one U.S. state.
• 5 to 8 years of experience with regulatory analysis, international exposure is a plus!
• Proven ability to provide thought partnership and leadership in developing innovative legal and risk management strategies.
• Excellent professional judgment, strong emotional intelligence, and a good sense of humor.
• Promotes a team environment that values, encourages, and supports diversity and ensures that different experiences, styles, backgrounds, and perspectives are leveraged appropriately.
• Exhibit high degree of professionalism and confidentiality in handling and having access to sensitive information.
• Experience with GDPR and other privacy risks and issues is a plus!
• Litigation experience is preferred.

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