Manager of Regulatory Affairs (Remote)

Clinical – Chief Medical Officer           ·            United States  (Remote)             ·         Full time / Part time

About Limbix: 

Limbix Health, Inc. is a distributed team building digital therapeutics for adolescents experiencing mental health disorders. Our goal is to give all young people access to affordable, effective behavioral health care by giving providers immediate, safe, and evidence-based treatment options they can offer to their patients. We value positive, motivated, authentic, and solutions-oriented individuals who want to join us on this mission.

About the Role: We are hiring a full time exempt Manager of Regulatory Affairs to ensure Limbix is in compliance with regulatory requirements. You will work alongside our product, clinical, and quality teams to ensure successful FDA clearance of our entire suite of products. This is a key role and will report directly to the Chief Medical Officer.

About the Team: We strive to execute our work with empathy and excellence, both individually and as a team. We acknowledge and appreciate the complexities of each other’s roles and responsibilities. We appreciate our diversity, and deeply value how the different cultures of our colleagues and teams vastly improve the quality of our work.  

Who you are: This is an excellent role for someone with strong organizational skills, the ability to teach and communicate clearly across teams, and has high attention to detail and ethical standards.

What you’ll be doing:

• Prepare and manage regulatory submissions (510(k), de novo) for prescription digital therapeutics
• Evaluate and support additional digital product development and distribution from a regulatory requirement standpoint
• Review and interpret changes in regulatory policies for impact on Limbix product development, processes, and compliance controls
• Collaborate with Quality and Product teams to continuously improve and develop processes in order to enhance conformity and compliance while accelerating market access
• Maintain regulatory files and documentation, consistent with state, federal and international regulatory requirements
• Serve as the main point of contact for regulatory agencies, coordinating regulatory filings, incident reports, audits, and registrations
• Work collaboratively with outside consultants and entities in support of regulatory requirements and advancing FDA product authorization and compliance
• Manage communications with regulatory agencies and response to FDA requests for comments
• Work collaboratively with trade groups in drafting comments to regulatory agencies and responses to FDA requests for comment

Desired Qualifications:

• 5+ years in regulatory affairs in a regulated industry; pharma, life sciences technology, digital therapeutics, med devices
• Solid understanding of ICH GCP, ISO 14155, HSP, HIPAA, CFR Title 21, and Clinical Trials Regulation under EMA
• Successful preparation and submission of 510(k)s and international documents or registrations
• Thorough knowledge of medical device design control and risk management processes and regulations, including software as a medical device
• Knowledge of clinical and data requirements in support of regulatory filings
• Progressive & proven record of leadershipHigh level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
• Bachelor’s degree in life sciences, engineering or business
• Excellent written and verbal communication skills in a fully virtual work environment
• Ability to thrive in a fast-paced, technical, and mission-focused environment
• Proven capacity to collaborate and build trust over time with cross-disciplinary audiences

Preferred Skills:

• Experience submitting applications and approval requests with international regulatory bodies
• Familiarity with CMS
• Developed regulatory strategies for U.S. and international markets
• Served as the central owner for all internal regulatory questions, ensuring that all questions are answered in an accurate and timely fashion (This may be through independent research or by identifying and managing external advisors where needed.)
• Partnered with Research and Product teams to develop and implement strategies for pipeline development

Salary Range: $131,367.15 to $158,954.25

Total Compensation Package – Full-time: 

Salary – competitive base; Meaningful equity

Premiere Standard Benefits – Medical, Dental, Vision (75% covered for both individual and family), Health  FSA, HSA, Life, AD&D, Disability, Education and Professional Development Reimbursement.

Cool Fringe Benefits – Health and Wellness stipend

Family Friendly – Liberal maternity/paternity time off to be used consecutively or intermittently; Generous earning schedule for annual PTO; 10 paid company holidays; Company shut down between Christmas and New year!

Financial Planning 401(k)

Total Compensation Package – Part-time:

Salary – Competitive base 

Cool Fringe Benefits – Health and Wellness stipend

Family Friendly – Annual PTO, 10 paid company holidays, Company shut down between Christmas and New Year!

Limbix Health, Inc. and E-verify

Limbix Health, Inc. an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Limbix validates right to work using E-Verify. Limbix will provide the Social Security Administration (SSA) and, if necessary, the Department of Homeland Security (DHS), with information from each new employee’s Form I-9 to confirm work authorization.

#LI-Remote 

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