Director of Regulatory Compliance

L7 Informatics

At L7 Informatics, Inc., our mission is to revolutionize scientific processes and data management to accelerate precision health across life sciences, healthcare, and nutrition value chains. 

Our end-to-end solutions and services enable researchers to make new genomics discoveries, precision therapeutics manufacturers to create higher fidelity therapies, health systems to provide superior diagnostics and standard of care, and precision agriculture to meet tomorrow's needs. 

The L7 culture is one of the biggest reasons why our people choose to stay.  Our culture is driven by four core values:  

1. Collaboration:  Listen empathetically to customers and colleagues. Seek first to understand. Actively listen with an open mind. 
2. Innovation: Inspire each other to think big, bring new ideas, imagine all possibilities. Maintain a safe to fail environment where all ideas are welcome & valued. Be vigilant in our pursuit of creative solutions.
3. Excel: Strive for excellence in all we do. Elevate expectations and performance with every opportunity. Provide "best in class" product, customer service, employee experience.
4. Growth: We recognize we don't know everything. Be courageous to ask the hard questions, give and receive respectful & actionable feedback. Invest in time for continuous learning and development.

The most successful L7’ers are naturally persistent and resilient when it comes to solving problems and servicing our customers.   They are full of grit, spunk and driven by our mission to make a positive impact on a very important industry that can improve healthcare for people around the world.

 Continuing on our path to driving excellence and quality, we are hiring a Director of Regulatory Compliance. This role will report directly to the President and CEO.   

The Director of Regulatory Compliance is responsible for owning the quality management system, including audit readiness, with consideration to company, customer, regulatory, and targeted certification requirements.

 What you’ll get to do:

• Build, develop, and retain a team of high-performing Quality professionals
• Negotiate with stake holders to improve quality and increase the efficiency of the quality system.
• Prepare training materials and coaching L7 employees on quality principles and audit techniques.
• Maintain knowledge of international regulations (e.g., GDPR).
• Support customer software submissions and inspections.
• Escalate issues to senior and executive management in a timely manner while suggesting & implementing appropriate solutions.
• Support execution of L7’s roadmap by collaborating with cross-functional teams to support L7 | ESP.
• Own and manage the external audit program, including but not limited to:
  1. Scheduling audits.
  2. Participating in audits.
  3. Responding to audit findings.
  4. Performing remediation activities, including timely completion of CAPAs, Deviations, and Change Controls.
  5. Optimizing the program to follow L7’s preferred audit approach (e.g., External Audit Guide, Audit Agenda Template, and Internal Guide for External Audits with Links).
  6. Leading crucial interactions with customers, regulatory agencies, and certification bodies.
• Owning and managing the internal audit program, including but not limited to:
  1. Scheduling audits.
  2. Participating in audits where possible.
  3. Assigning and training auditors.
  4. Performing remediation activities, including timely completion of CAPAs, Deviations, and Change Controls.
• Owning and managing certification efforts (e.g., ISO 9001 and 510K).
• Working with the Quality Compliance team to maintain the quality system, including but not limited to:
  1. Leading process improvement initiatives to drive continuous improvement.
  2. Providing guidance on updating SOPs to meet company, customer, regulatory, and targeted certification requirements.
  3. Ensuring that the requirements of SOPs are understood at all levels and implemented effectively.
  4. Support and participate in L7’s quality management system (QMS) by complying with the Quality Policy and SOPs, and by meeting L7’s QMS objectives.

What will make you a good fit:

Relevant Experience / Skillset: 

• Minimum 10 years of experience managing external audits within a regulated environment (e.g., medical device, pharmaceutical)
• Strong background with FDA’s Code of Federal Regulations.
• Expert level knowledge of ISO standards (e.g., 9001, 13485).
• Software development life cycle knowledge.
• Experience authoring technical documentation within a regulated environment.
• Effective organization and project management skills, with the ability to successfully manage priorities in a time sensitive environment
• Experience managing external audits and implementation of quality management systems. 
• Experience with quality management system processes such as risk management, document control, change control, non-conformances, corrective and preventive actions, etc. 

 Leadership:

• Accountable and results-oriented leader with proven ability to motivate and develop people.
• Proven ability to achieve results in a fast-paced, dynamic environment, with the ability to function in a startup environment
• Strong oral and written communication including next-level listening skills
• Naturally team focused with grounded interpersonal skills including the ability to handle and resolve conflict

 Education:

• Bachelor's degree or higher (ideally in a relevant discipline)

 What will make you stand out

• Experience with:
  • FDA’s CFR (e.g., Part 11, Part 820) 
  • Regulatory submissions of software to the FDA
  • A laboratory information management system (LIMS) 

 The (Typical) Hiring Process

• A phone call with someone from our talent team
• First meeting with the hiring manager to learn more about the role and your background 
• A technical take home assignment (if applicable)
• Interviews with 2-3 members of the team
• Final interview with hiring manager

Even if your experience and skills do not exactly match the job description, we value passion and curiosity and recognize that everyone comes with a unique background and perspective. If you’re not sure if you meet the qualifications of this exact role, we encourage you to join our Talent Community on our career page so that we can consider you for the right role when it the need arises.  

EOE STATEMENT

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, sexual orientation, gender identity, disability status, protected veteran status or any other characteristic protected by law.