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FDA Compliance Coordinator

Kindbody

Kindbody

Legal
New York, NY, USA
Posted on Thursday, May 16, 2024

About Kindbody

Kindbody is a leading fertility clinic network and global family-building benefits provider for employers offering the full-spectrum of reproductive care from preconception to postpartum through menopause. Kindbody is the trusted fertility benefits provider for 127 leading employers, covering more than 2.7 million lives. Many thousands more receive their fertility care directly from Kindbody throughout the country at signature clinics, mobile clinics, and partner clinics. As the fertility benefits provider, technology platform, and direct provider of care, Kindbody delivers a seamless, integrated experience with superior health outcomes at lower cost, making fertility care more affordable and accessible for all. Kindbody has raised $315 million in funding from leading investors.

Founded in 2018, CB Insights recognized Kindbody as one of the world’s promising health companies. Kindbody was named to Inc.’s Best In Business list of most admired companies, Forbes Best Startup Employers, Fast Company’s Brands that Matter, 2023 Linkedin Top 50 Startups list, and Fierce Healthcare named Kindbody to its Fierce 15 list of 2022, which recognizes the most promising healthcare companies in the industry world. Kindbody was named to the 2023 CNBC Disruptor 50 list for revolutionizing the way fertility care is delivered in the U.S.

About the Role

Reporting to our SVP, Clinical Excellence you will be working in a fast-paced, rapidly growing environment where you will be relied on for your expertise, professionalism, and collaboration. This role is a full time remote position. FDA Compliance Officer is responsible for all aspects of third party FDA compliance which includes but is not limited to donor/ IP/ Gestational Carrier testing/requirement, customer service, and infertility care. This position collaborates with the physicians and clinical teams to coordinate FDA screening and required testing of donors/ IP/ gestational carriers. The FDA compliance officer is expected to function independently in the role, seeking assistance from the physicians, the manager and team members as needed.

Responsibilities

  • Developing, implementing and enforcing standard operating procedures and policies to ensure the organization's compliance with industry and government regulations, including but not limited to FDA and tissue bank regulation..
  • Consistent risk assessments to recognise areas where the company might be vulnerable to non-compliance.
  • Working with other departments in the company, such as the legal, human resources and finance departments, to ensure compliance of all departments.
  • Participation in key inspections including FDA and State tissue bank inspections
  • Complete donor/patient/gestational carrier assessment, collection, and interpretation of pertinent data relevant to FDA Screening and Eligibility.
  • Thorough understanding of the FDA tissue regulations assures compliance for all tissue types.
  • Documentation of all assessments, interventions, and donor/IP/GC responses.
  • Provide teaching and ability to answer patient questions, utilizing resources needed and available.
  • Communicate the patient's condition to MD’s and other providers as needed/appropriate.
  • Promote a positive work environment, be accountable for personal conduct and actively participate in staff meetings and problem solving.
  • Demonstrate organizational skills that provide efficient patient care and smooth operation on a daily basis.
  • Detail oriented approach to paperwork, ensuring it is signed, accurate and complete.
  • Coordinate chart review prior to procedure to assure all eligibility paperwork is accurate, reviewed and signed off on prior to tissue procurement,
  • Maintain HIPAA and Confidentiality for all patient and clinic information, HIV confidentiality.
  • Other duties as assigned.

Who You Are

  • Bachelor’s degree in health sciences with a 5+ years experience in an FDA compliance related role in a fertility practice
  • Thorough knowledge of the industry standards, laws and regulations, including but not limited FDA and tissue bank regulations NY State Tissue Bank knowledge a plus..
  • Demonstrable experience in compliance and risk management.
  • Familiarity with developing and executing compliance management techniques.
  • Experience in conducting audits and investigations and providing relevant strategies.
  • A passion for women’s health, fertility
  • Experienced in EMR and G-Suite
  • Strong communication skills & a team player
  • Willingness to be flexible and can adapt to challenging situations.
  • Detail oriented
  • Experience working in a fast paced environment
  • Exemplifies strong customer service skills and professionalism
  • Care Coordination
  • Experienced working with high patient volume

Perks and Benefits

Kindbody values our employees and wants to do everything to ensure that our employees are happy and professionally fulfilled, but also that they have the opportunity to be healthy. We are committed to providing a number of affordable and valuable health and wellness benefits to our full-time employees, such as paid vacation and sick time; paid time off to vote; medical, dental and vision insurance; FSA + HSA options; Company-paid life insurance; Short Term + Long Term Disability options; Paid Parental Leave (up to 12 weeks fully paid dependent on years of service); 401k plans; monthly guided meditation and two free cycles of IVF/IUI or egg freezing and free egg storage for as long as you are employed.

Additional benefits, such as paid holidays, commuter transit benefits, job training & development opportunities, social events and wellness programming are also available. We are constantly reevaluating our benefits to ensure they meet the needs of our employees.

In an effort to protect our employees and our patients, Kindbody strongly encourages all employees to be fully vaccinated against COVID-19. However, some states are requiring that all healthcare workers be fully vaccinated. Candidates seeking employment at Kindbody in the following states will be required to be fully vaccinated against COVID-19 and provide proof of your COVID-19 vaccine prior to your start date of employment: New York. All other states are exempt from this requirement. If you cannot receive the COVID-19 vaccine because of a qualifying legal reason, you may request an exception to this requirement from the Company. If this is a remote position, the requirement would not apply.

Please note that Kindbody interview requests and job offers only originate from an @kindbody.com email address. Kindbody will also never ask for bank account information (including routing or account numbers), social security numbers, passwords or any other sensitive information to be delivered over email or phone. Always reference our career site, careersatkindbody, to see if the position that you are applying to is legitimate. If you receive a scam issue or a security issue involving Kindbody please notify us at talent@kindbody.com.

Kindbody is an Equal Employment Opportunity employer. We strongly support the principles of equal employment opportunity in all of our employment and hiring policies and practices and believe that a more diverse and inclusive workplace will benefit our patients, care partners, and Kindbody employees. We administer our employment and hiring policies and practices without regard to race, color, religion, sex, gender, gender identity, gender expression, pregnancy, citizenship, national origin, ancestry, age, disability, medical condition, military service, military or veteran status, genetic information, creed, marital status, sexual orientation, or any other status protected by federal, state, or local law.

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