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Everly Health's mission is to transform lives with modern, diagnostics-driven care, and we believe that the future of healthcare is meeting people where they are. Headquartered in Austin, Texas, Everly Health is the parent company to Everlywell, Everly Health Solutions, Natalist, and Everly Diagnostics. We've set a new standard of people-focused, diagnostic-driven care that puts patients at the center of their own health journey.   Our infrastructure guides the full testing experience with the support of a national clinician network that's composed of hundreds of physicians, nurses, genetic counselors, PharmDs, and member care specialists. Our solutions make world-class virtual care more attainable with rigorous clinical protocols and best-in-class science to tackle some of the healthcare industry's biggest problems.   The Director of Regulatory & Quality Affairs will lead and facilitate both Quality Management Systems and the Regulatory Affairs department to ensure compliance with regulation and federal agencies. They will lead quality-related inspection and contribute cross-functionally with their broad experience and leadership capability. This inidual will oversee the maintenance of Quality Assurance programs, policies, processes, and procedures to ensure that performance and quality of products conform to established standards.    The ideal candidate possesses a broad base of regulatory experience and a high level of technical depth applicable to medical device and software design, along with QMS experience. In this role, you are an advocate for quality and support best quality management and quality design practices. You will work with development teams to encourage agile design concepts in an engaging and positive way.

< class="h3">What You'll Do:

• The Director of Regulatory & Quality Affairs directs, plans, develops, coordinates, and implements all practices, programs, strategy, and personnel activities of the organization's Quality Affairs Department.

 

• Quality: 

• Oversee QA Manager to ensure compliance with regulation, lead the implementation, maintenance, and expansion of our corporate and laboratory Quality Management Systems and biological/facilities safety, and support regulatory strategy.

 

• Regulatory:

• Lead Regulatory Affairs department with expertise in the requirements of regulators and other federal agencies such as the FDA. This also includes responsibility for preparation, submission and maintenance of PMAs, 510(k)s, EUAs, etc. 

• Experience with researching, creating and executing on Regulatory strategies for products, including Laboratory Developed Tests, 510k clearances, Direct to Consumer and other considerations

• Ensure that quality system requirements for medical devices are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304 and other regulations and guidelines as applicable.

• Serve as FDA Management Representative

 

• Laboratory:

• Maintain compliance with FDA, GMP/QSR, QMS, CLIA, and CAP laboratory frameworks.

• Ensure end-to-end management and maintenance of quality systems across the laboratory networks.

• Support FDA, NYDOH, and HHS audits.

 

• R&D:

• Partner closely with Research & Development regarding the clinical development programs needed to support regulatory strategy and submissions to health authorities, determine clinical feasibility of new products and all required documentation related to developing and implementing new products.

• Conduct critical assessments via internal audits of all processes and equipment to identify areas of improvement

• Conduct Management Reviews as scheduled, be responsible for the evaluation and dissemination of company quality standards, initiatives, guidelines.

• Maintain Quality Assurance programs, policies, processes, and procedures to ensure that the performance and quality of products conform to established standards

• Establish and maintain US and international product and manufacturing certifications

< class="h3">Who You Are:

• 10 years' experience in Regulatory Affairs, working at or with FDA-cleared medical device companies. Must have hands-on experience in developing and implementing comprehensive Regulatory Affairs & Quality processes, procedures and strategies.

• Thorough understanding of International Conference on Harmonization (ICH), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) requirements, regulatory compliance (including ISO 13485, ISO 14971, and ISO 62304, FDA 21 CFR Part 820, and reporting. 

• Experienced with coordination and direct submission activities for a variety of regulatory approvals including PMAs.

• Experience leading FDA, NYSDOH, HHS audits.

• Experience with physical and digital products, novel assay and rapid point of care, and digital health apps.

• Experience with process design and improvement and with developing systems and continuous improvements on including QMS.

• Start-up medical device experience and experience in a fast-paced development environment. 

• Working experience in full-lifecycle engineering programs and processes. 

• Strong working knowledge of Medical Device and Diagnostic regulations and quality assurance practices. 

• Adaptability, flexibility, independence, and resourcefulness to both lead a big vision strategy while also willing to roll-up-sleeves and multi-task to thrive in a growing environment. 

• Outstanding communication skills (verbal and written), with excellent listening skills. 

• High attention to detail and pace – thorough, quick, and makes self- and team-accountability as a top priority. 

• Executive experience, superior judgment, and ability to formulate solutions from a broad perspective. 

• Strong project and people management and collaboration skills and an ability to communicate effectively, both internally and externally. 

• Ability to demonstrate executive presence in dealing with complex issues, dealing with ambiguity, and making timely, high-quality decisions. 

• Proven ability to operate “hands on” and successfully in a rapidly growing organization.

• Willingness to travel to facilities as required (up to 25%)

  The base salary range for this role is $150,000 - $180,000 USD. The actual salary offered will be based on the selected candidate's qualifications, market data/ranges, and internal equity. This position is also eligible for a yearly bonus.   You'll Love Working Here:   · Venture backed by top-tier firms · The opportunity ahead knows no bounds · Open vacation policy for salaried team members · Front Loaded PTO for hourly team members · Employee discounts · Paid parental leave · Health benefits · 401(k)   NO EXTERNAL RECRUITERS - INDIVIDUAL APPLICANTS ONLY   Everly Health is committed to providing equal employment opportunities in all employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship status, marital status, age, disability, protected veteran status, sexual orientation or any other characteristic protected by law.   HIPAA Disclaimer: This role will be in an environment that has access to protected health information (PHI) and all security standards to protect PHI must be followed.