We are partnering with our client, Active Protective Technologies, to hire a Director of Quality & Compliance!

About Active Protective Technologies: 

Active Protective Technologies is a medical device startup committed to revolutionizing the treatment of older adults at risk of a fall-induced hip fracture due to diagnosed osteoporosis and fall risk. Our flagship product, the Tango Belt, integrates cutting-edge technology into a wearable device that detects a serious hip-impacting fall in progress and deploys an airbag at the hips to attenuate impact force and mitigate fall-induced major hip injury, a leading cause of disability and death in older adults. The Tango® Belt was designated a Breakthrough Device by the FDA to recognize its potential to significantly improve the standard of care for this debilitating condition. The FDA granted us De Novo authorization to begin marketing the Tango Belt in April 2025, and US commercialization is underway. For more info on our mission and product, please visit www.tangobelt.com.

Job Overview: 

Active Protective seeks a Quality & Compliance Director with both industry-standard technical skills and an attitude to contribute to a collaborative, positive work environment. In this role the Quality & Compliance Director is ultimately responsible to meet compliance requirements for the business, under both Food & Drug Administration and Centers for Medicare Services. Quality & Compliance Director directly oversees Quality Management Systems, Regulatory/Compliance, directing employees as needed, and works cross-functionally with Executive, Engineering, Information Technology, Clinical, Finance, Human Resources, and Commercialization personnel.

Key Responsibilities: 

• Regulatory Affairs: Maintain compliance with U.S. Food & Drug Administration requirements, serving as the operational owner for all required registrations and licenses, regulatory readiness, government audits, and corrective actions. Represent Regulatory Affairs within the Product Development team. Chiefly responsible for compliance of all product labeling, instructions for use, and marketing claims. Work cross functionally with Engineering, Clinical & Marketing.
• Quality Management Systems: Oversee the Quality Management System in accordance with ISO 13485 and FDA Quality System Regulation (21 CFR 820), including document control, audits, non-conformance, complaint handling, quality inspections, CAPA, and continuous improvement. Represent Quality within the Product Development team. Work with Engineering regarding issues related to product design and defects; work with all other cross-functional groups as needed to ensure implementation of compliant procedure.
• Durable Medical Equipment Program Compliance: Work cross-functionally to ensure Durable Medical Equipment (DME) program compliance with Medicare DMEPOS supplier standards, accreditation, and Medicare requirements. 
• HIPAA Compliance Program: Work cross-functionally with Information Technology, Software Engineering, Clinical and Commercial Operations to ensure compliance with HIPAA requirements for the safeguarding of protected health information (PHI), protecting company and customer data, and maintaining system integrity.
• Health & Safety Program Compliance: Work cross functionally with Facilities, Product Operations and Human Resources to provide a safe, secure, work environment in compliance with OSHA, Medicare and FDA standards.
• Government & Legal Affairs: Directly oversee legal and government affairs operations. Maintain connections with key trade groups, lobbying groups and government officials. Support review of company contracts, terms & conditions, and official statements, working with external counsel as needed. 
• Continuous Improvement: Establish, monitor, and improve work processes and outputs under assigned responsibilities.

Qualifications:

• Education: Bachelor’s degree in engineering or scientific discipline; Compliance certifications are a plus;
• Experience: Minimum of 10 years of experience in an FDA or CMS regulated space;
• Personal Skills: Strong communication skills, both written and verbal. Strong ability to work collaboratively and cross-functionally with team members, and to work under business direction. 
• Technical Skills:
  • Strong organizational skills a must.
  • Strong attention to detail is a must.
  • Strong knowledge of FDA requirements and quality management principles (ISO 13485).
  • Strong knowledge of Medicare Durable Medical Equipment requirements.
  • Proficiency with relevant software (e.g. eQMS, word processing, etc.)
• Knowledge: Strong understanding of medical device quality, logistical and manufacturing processes, quality assurance practices, and industry standards.

Physical Requirements:

• Must be present 2 days per week in-office, and available in office as needed.
• Must be available for business travel (e.g. supplier visits) as needed.
• Must have no violations of Medicare or HIPAA.