Description:

About the role:
As we continue to expand our global footprint, we are seeking a dynamic and experienced In-House Counsel to join our team.

As In-House Counsel, you will play a critical role in facilitating contractual agreements with world-class partners and customers and assisting with our company's compliance with various legal and regulatory requirements. Your responsibilities will encompass a broad spectrum of legal matters, with a focus on sales agreements, compliance, regulatory affairs, and risk management in the healthcare and technology sectors. This role will report to the Company's Chief Strategy Officer.

Responsibilities:
Contract Negotiation, Drafting, and Compliance:

Lead legal elements of contract negotiations with customers, suppliers, and partners, ensuring favorable terms while mitigating legal risks.
Draft, review, and negotiate a wide variety of contracts, including confidentiality agreements, business associate agreements, material transfer agreements, collaboration/development agreements, sales and licensing agreements (including SAAS agreements and terms of service agreements), distribution agreements, partner programs, etc. Counter-parties include a wide range of organizations, including laboratories, academic medical centers, hospital systems, healthcare distribution organizations, biotech firms, research institutions etc.,
Ensure compliance with contractual obligations and regulatory requirements, including intellectual property rights, data privacy, and confidentiality provisions.

Compliance and Regulatory Affairs:

Monitor and interpret laws, regulations, and industry standards related to digital pathology, AI algorithms, and healthcare technology.
Develop and implement compliance programs to ensure adherence to international privacy and security regulations and compliance frameworks, including GDPR, HIPAA, SOC2, and ISO13485.
Stay abreast of emerging regulatory trends and changes in the healthcare landscape, advising the company on potential impacts and strategies for compliance.

FDA and CE Filings and Compliance:

Collaborate with the Regulatory team on regulatory filings and interactions with regulatory authorities, particularly the FDA and CE, to ensure product approvals and maintain compliance with applicable regulations.
Collaborate with various cross-functional teams to navigate regulatory pathways for new products and modifications to existing products.
Conduct regulatory assessments and risk analyses to support product development and commercialization efforts.

General Legal Support and Contract Management:

Provide legal guidance and support to various business units, including sales, marketing, R&D, and operations, on contract-related matters.
Supervise and manage outside counsel in various practice areas when outside expertise/support is required, for example, with respect to the management of the company's IP portfolio.
Manage the company's contract lifecycle, from initiation to renewal or termination, ensuring proper documentation and compliance with internal policies and procedures.
Maintain and update contract templates, standard terms and conditions, and other legal documents as necessary.

Risk Management and Litigation:

Identify potential legal risks associated with contracts and develop strategies to mitigate such risks.
Collaborate with external legal counsel as necessary to address litigation matters, including intellectual property disputes, regulatory investigations, and other legal proceedings.
Assist in the development and implementation of policies and procedures to minimize legal exposure and safeguard the company's interests.

Required Skills / Abilities

Juris Doctor (JD) degree from an accredited law school.
3 to 5 years of relevant transactional legal experience, preferably with a focus on healthcare, technology, or life sciences.
Excellent negotiation, drafting, and contract management skills.
Familiarity with international privacy and security regulations, such as GDPR and HIPAA is preferred.
Ability to place legal work in its business context and advise business teams appropriately on legal risk.
Ability to work independently and collaboratively in a fast-paced environment.
Strong understanding of healthcare regulatory frameworks, including FDA and CE requirements is preferred.
Admission to the bar in good standing in at least one jurisdiction.

Preferred Skills/Abilities
Prior experience at a reputable law firm, followed by in-house counsel experience with a healthcare-related company, is preferred.