About Sequel Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.
Job Overview Sequel Med Tech is seeking a highly skilled and experienced Senior Director, Legal to join our dynamic team. Reporting directly to the Vice President - Legal, the Senior Director will play a pivotal role in providing legal support throughout the organization, and in particular for establishing new product and other new business innovations. The successful candidate will collaborate closely with business leaders to anticipate and address potential legal concerns and ramifications associated with new ideas and initiatives relating to medical device regulations, the FDCA, Anti-Kickback Statute, and privacy laws. Additionally, the Senior Director will assist the VP, Legal with various legal areas as needed, including contract support, Sunshine Act compliance, employment law matters, and establishing company compliance policies and procedures.
Job Responsibilities and Essential Duties - Provide strategic legal counsel and guidance to support the establishment of new product and business innovations.
- Provide legal support and guidance on medical device regulations, including FDA requirements and international regulatory standards.
- Collaborate with cross-functional teams to identify and mitigate legal risks associated with new initiatives, products, and partnerships.
- Serve as an escalation contact for complex contract negotiation, drafting, and review, ensuring that all agreements align with company objectives and legal requirements.
- Assist with Sunshine Act compliance and reporting obligations, including the monitoring and disclosure of interactions with healthcare professionals.
- Collaborate with external legal counsel as necessary to address complex legal matters and ensure optimal outcomes for the company.
- Support the VP, Legal with additional legal initiatives and projects as needed to meet the evolving needs of the organization.
Minimum Requirements - Juris Doctor (JD) degree from an accredited law school and active membership in good standing with the state bar.
- 8+ years of legal experience, with a focus on providing counsel to medical device companies or supporting new medical device innovations.
Required Knowledge, Skills, and Abilities - Strong knowledge of FDA requirements, privacy laws, and AKS statute
- Experience advising on contract matters, including negotiation, drafting, and review.
- Familiarity with Sunshine Act and other compliance requirements and reporting obligations.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.
- Proven ability to think strategically, anticipate legal issues, and provide proactive solutions.
- Strong analytical skills and attention to detail, with the ability to prioritize and manage multiple projects in a fast-paced environment.
- Demonstrated leadership capabilities and experience managing legal teams or initiatives is preferred.
- Experience building processes and procedures in a startup environment preferred.
Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Environmental/Safety/Physical Work Conditions - Ensures environmental consciousness and safe practices are exhibited in decisions.
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments
- May work extended hours during peak business cycles.
- Physical requirements such as lifting specific weights.
- Some travelling is expected.