General Counsel for Diagnostic Blood Testing Company

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We are a U.S.-based distributor of a blood diagnostic test designed to reveal chronic inflammation levels in the body. Our team is a group of professionals who have worked together on the last two companies, so we've built a strong familial culture. Our mission is to empower individuals and healthcare providers with actionable insights to improve long-term health outcomes. As we expand our reach in the healthcare diagnostics market, we are seeking a dynamic and experienced General Counsel to oversee our legal and compliance functions and ensure the company operates at the highest levels and within the bounds of applicable laws and regulations. Position Overview The General Counsel will be the primary legal advisor for the organization, responsible for managing all aspects of legal, compliance, and regulatory affairs. This individual will work closely with the CEO and COO to navigate the complexities of healthcare regulations, contracts, and business partnerships. The role requires a proactive and strategic thinker who can balance legal risk management with the company’s growth objectives. This is a remote position, but candidates must be authorized to work in the United States and possess a comprehensive understanding of U.S. healthcare regulations. Key Responsibilities ------ Legal Strategy & Compliance: Learn what we have in place already, then develop and implement a comprehensive legal strategy that supports the company’s business objectives. Ensure compliance with federal, state, and local laws, with a focus on healthcare-related regulations, including FDA, HIPAA, and CLIA. Monitor changes in laws and regulations that may impact the company’s operations and provide timely guidance to the leadership team. Regulatory Affairs: Oversee compliance with all applicable healthcare and diagnostic product regulations. Collaborate with regulatory agencies (e.g., FDA) to ensure product approvals, registration, and ongoing compliance. Guide the company on advertising, labeling, and promotional activities to ensure compliance with regulatory standards. Contract Management: Draft, review, and negotiate contracts, including distribution agreements, vendor contracts, licensing agreements, and partnership agreements. Create and manage processes for contract approval, execution, and tracking. Risk Management: Identify and mitigate legal and compliance risks across all aspects of the business. Develop internal policies and procedures to ensure adherence to legal and ethical standards. Intellectual Property: Protect the company’s intellectual property, including trademarks, copyrights, and trade secrets. Collaborate with external counsel on intellectual property filings and enforcement as necessary. Employment Law: Advise on employment matters, including hiring practices, employment agreements, non-compete clauses, and workplace policies. Ensure compliance with labor laws and regulations. Corporate Governance: Serve as a key advisor to the executive team and, if applicable, the Board of Directors, on corporate governance matters. Draft and maintain corporate governance documents, including bylaws, policies, and other governance-related materials. Litigation Management: Provide oversight for any legal disputes or litigation involving the company. Manage relationships with external counsel as necessary. Team Collaboration: Act as a strategic partner to business units, offering practical legal advice that aligns with organizational goals. Build and mentor a legal and compliance team as the company grows. Requirements Education & Licensure: Juris Doctor (JD) degree from an accredited law school. Active bar membership in good standing in at least one U.S. jurisdiction. Experience: Minimum of 8-10 years of legal experience, with at least some relevant experience in the healthcare, diagnostics, or life sciences industry. Strong familiarity with U.S. healthcare laws and regulations, including FDA, HIPAA, and CLIA compliance. Experience negotiating and drafting complex contracts. Proven experience advising on regulatory matters and working with regulatory agencies. Skills & Competencies: Deep understanding of the U.S. legal and regulatory landscape for diagnostic products and healthcare services. Strong negotiation, drafting, and problem-solving skills. Exceptional written and verbal communication skills, with the ability to convey complex legal concepts in plain language. Proactive and solutions-oriented mindset, with the ability to manage competing priorities in a fast-paced environment. Ability to work independently in a fully remote setting while maintaining strong collaboration with team members. Preferred Qualifications: Experience working with diagnostic product distribution or similar business models. Familiarity with international healthcare regulations is a plus. Experience managing legal aspects in a startup or rapidly growing company.

Keyword: Technical Writing

Price: $75.0

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