Kindbody is hiring a
FDA Compliance Officer in United States

Summary

Kindbody is a leading fertility clinic network and global family-building benefits provider for employers. The company has been recognized as one of the world’s promising health companies and offers full-spectrum reproductive care from preconception to postpartum through menopause. The role of an FDA Compliance Officer involves ensuring the organization's compliance with industry and government regulations, including but not limited to FDA and tissue bank regulations. They are responsible for developing, implementing and enforcing standard operating procedures and policies, conducting risk assessments, coordinating with other departments, participating in inspections, and maintaining HIPAA and confidentiality.

Requirements

• 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 to 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

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 recognize 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

Benefits

• 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
• Paid holidays, commuter transit benefits, job training & development opportunities, social events and wellness programming are also available