FDA Compliance Coordinator, Kindbody
Fertility benefit provider
Job no longer available
Fertility benefit provider
501-1000 employees
Job no longer available
501-1000 employees
Company mission
To change the way we look at healthcare, and make the process of going to the doctor more intuitive and empowering.
Role
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
What the job involves
- 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
- FDA Compliance Coordinator 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 Coordinator is expected to function independently in the role, seeking assistance from the physicians, the manager and team members as needed
- 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
Our take
Kindbody is a modern healthcare company that provides fertility, gynaecology, and family-building services to individuals and employers. The company has created a comprehensive benefit network that offers employers a more affordable and accessible way to support their employees' reproductive health.
Through the Kindbody benefit network, employers can provide their employees with a range of services, including fertility evaluations, egg freezing, in vitro fertilization (IVF), genetic testing, and more. Designed to make high-quality reproductive healthcare more accessible and affordable, Kindbody works with a number of licensed medical professionals in order to offer personalized and compassionate care for its patients. By offering comprehensive reproductive healthcare coverage, it is allowing employers to attract and retain top talent while also promoting a culture of inclusivity and support.
Since its inception in 2018, Kindbody has quickly become a leading provider of reproductive healthcare services for over 112 employers, covering more than 2.4 million lives. The company has successfully partnered with major players in various industries, including Walmart, Medtronic, Lyft, and GEICO. With its recent acquisitions and funding, Kindbody is well-positioned for growth and plans to expand its operations in the near future.
Freddie
Company Specialist at Welcome to the Jungle
Company
Funding (last 2 of 10 rounds)
May 2023
$25m
LATE VC
Mar 2023
$100m
LATE VC
Total funding: $306.4m
Company benefits
- Paid vacation and sick time
- 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
- Two free cycles of IVF/IUI or egg freezing and free egg storage
- Job training & development opportunities
- Social events and wellness programming
Company HQ
Midtown Manhattan, New York, NY
Leadership
Gina Bartasi
(Founder)Serial entrepreneur having previously founded The Leader Publishing Group, Fertility Authority, Progyny, and Tech-Health.
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