Job Details
Are you ready to join Connecticut Innovation s vibrant community of innovators? Connecticut Innovations ( CI ) is Connecticut s strategic venture capital arm, and we are passionate about serving our portfolio of 220+ companies across various industries, with strengths in life sciences, technology, and climate tech.
Come join one of our quickly growing portfolio companies, Perosphere Technologies!
Perosphere Technologies is hiring a General Counsel in Danbury, CT! This will be an onsite role, 5 days a week.
About Perosphere Technologies
Perosphere Technologies is changing the way decisions are made for patients at risk for bleeding. A private medical technologies company, Perosphere is focused on development and commercialization of the novel PoC (point-of-care) Coagulometer, which informs diagnosis, treatment, and prevention through precision data, made immediately accessible to all. It is the only point-of-care (POC) diagnostic tool that effectively and swiftly tests clotting times across drug classes, including Direct Oral Anticoagulants (DOACs). The fast diagnosis and related appropriate treatment decisions the PoC Coagulometer enables will help establish a new standard of care in hospital emergency departments for patients at risk for bleeding and has the potential to improve efficiency, provide significant cost savings, and better patient outcomes.
Perosphere Technologies is funded by Advantage Capital Partners, Ambit Health Ventures, Connecticut Innovations, Ogden, and others, and has been awarded multiple federal grants from the National Institutes of Health (NIH).
Position Summary
The General Counsel, will support a wide variety of global matters related to the design, manufacture, distribution and sale of medical devices including product submissions, premarket activities, marketing and promotion, quality system regulation, manufacturing activities, field corrective actions, clinical trial agreements and labeling requirements. This role will work closely with members of the Executive Team to drive overall global strategy, improvements and risk mitigation, and other key initiatives.
Responsibilities: Essential Duties
- Provide solutions-oriented and strategic legal advice relating to interactions with regulatory authorities.
- Review and provide legal advice on labeling, advertising and promotional materials.
- Provide legal support in the development and implementation of policies, procedures, product manuals, legal guidance documents, and training materials as well as trainings of personnel, on regulatory and quality matters.
- Draft, review, and negotiate agreements for the operations, quality, regulatory and medical affairs departments, including but not limited to, quality agreements, clinical trial agreements, services agreements, material transfer agreements and research agreements.
- Provide legal advice to sales, marketing, finance, procurement and other departments to develop and refine contract terms.
- Advise as needed on product liability counseling.
- Monitor legislation, regulations, case law, and government oversight activities relating to regulatory and quality issues and provide proactive, strategic advice.
Expertise: Knowledge & Skills
- Strong attention to detail.
- Ability to handle multiple, competing workloads with changing priorities to meet necessary deadlines.
- Ability to effectively work with all levels of the organization.
- Handle long-term and/or complex legal projects with significant financial or other business impact.
- Strong business and financial acumen as well as superior analytical and writing skills.
Expertise: Qualifications - Experience/Training/Education/Etc.
- JD Degree from a U.S. Accredited law school.
- Admission to at least 1 U.S. state bar or District of Columbia.
- 8+ years of regulatory and quality experience - at a top tier law firm and in an in-house legal organization.
- Experience providing legal advice regarding environmental, health, safety and security regulations and practices at U.S. manufacturing facilities.
- Strong expertise in U.S. federal and state medical device and/or pharmaceutical legal, regulatory and quality environments, including end-to-end support of regulatory approvals, post-market activities, quality management systems, sales and distribution, advertising and promotion, product clinical claims and manufacturing processes.
- Knowledge of medical device regulations and guidances, anti-kickback laws, false claims act, foreign-corrupt practices act, Physician Payments Sunshine Act, HIPAA, and related industry guidance.
- Experience working with international regulatory, quality, and legal teams in connection with the Essential Duties described above.
- Demonstrated leadership responsibility involving all aspects of legal support of quality and regulatory matters, including the matters referenced above
- Business Acumen - Understanding of basic business concepts, strategies, and risks
- Analytical Skills - Excellent judgment, strategic and analytical thinking and the ability to assess risk and mitigations and make recommendations based on the company s values, vision, business goals and risk appetite
- Innovation - Strong problem-solving/creative skills that drive new business solutions
- Project Management - Strong priority-setting skills, attention to detail and the ability to work on multiple projects at the same time
- Communication - Excellent verbal and written communication skills to allow effective interaction with all levels of the organization
- Growth Mindset Possesses a growth mindset with a passion for learning new things
- Collaboration Ability to thrive in a team environment
- Diversity & Inclusion - Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
Why Work At Perosphere Technologies?
- 1 out of 3 DOAC Patient Admissions are incorrectly diagnosed and treated
- Perosphere s Coagulometer (ClotChek) is the only PoC device that can test coagulation in patients on DOACs
- ~$1 billion market opportunity across Emergency Department, DOAC Outpatient, and Heparin Inpatient segments
- $1 billion in cost reduction to hospitals and payers in the US, with improved standard of care
- Coagulometer readers and cuvettes manufactured under cGMP, ready for commercial production with launch in Europe in 2024 and U.S. to follow
- Company has doubled its employees in the last 15 months, with more planned hiring in 2024 and 2025
Perosphere Technologies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.