• Acts as the SafelyYou expert and trusted advisor regarding state, federal, and international regulatory requirements, assessing their applicability to SY software and services for the various markets we serve (AL, MC, SNF, Home) and/or locations in which we install our solutions. • Identifies and develops relationships between SY and regulatory administrators, meeting annually and updating regulatory requirements as necessary. • Conducts quality assurance activities to confirm SY's requirements definition is accurate. • Prepares policies, procedures, and training materials to support internal (company) and external customer needs related to regulatory requirements. • Leads submissions, communications, and meetings with regulatory authorities to support and ensure compliant customer installations. • Supports the operations, clinical, and sales team with customer interactions when they require support related to regulatory affairs. • Assesses new SY software and services offerings for regulatory compliance and risk. • Other duties as assigned.

Role Description The Legal Counsel & HIPAA Compliance Officer is responsible for overseeing the implementation and maintenance of policies and procedures within ClearWellness, ensuring compliance with the Health Insurance Portability and Accountability Act (HIPAA), safeguarding patient health information (PHI) by conducting risk assessments, monitoring data access, investigating potential breaches, and educating staff on privacy practices. In addition to overseeing ClearWellness’ HIPAA program, this role will work on a wide range of business legal matters associated with all aspects of health and wellness focused organization including state and federal regulatory issues, contract review and negotiation, BAA review and privacy policies. - Develops, reviews, updates, and communicates HIPAA compliance policies, procedures, and operational standards to ensure alignment with applicable legal and regulatory requirements. - Conducts regular HIPAA audits, risk assessments and compliance reviews to identify gaps or vulnerabilities and implement corrective actions. - Implements and oversees appropriate technical, physical, and administrative safeguards to mitigate identified regulatory risks. - Monitors ongoing compliance activities and supports compliance programs to ensure continued adherence to HIPAA and applicable legal standards. - Investigates incidents of suspected or reported HIPAA breaches and manages required reporting in accordance with Federal and State Laws and HIPAA guidelines. - Develops, maintains, and delivers comprehensive HIPAA training programs, including regular updates to ensure staff awareness of regulatory requirements and best practices. - Reviews and manages contracts with third-party vendors who access PHI to ensure they comply with HIPAA regulations. - Drafts, reviews, and negotiates contracts and legal documents with third parties, including vendors that access or process PHI. - Oversees litigation, dispute resolution, and coordination with external counsel and third-party law firms as needed. - Collaborates with healthcare providers, IT staff, legal counsel, and senior management to address HIPAA concerns and implement compliance strategies. - Provides strategic and accurate legal advice to executive leadership and various departments to support business objectives. - Collaborates as needed with ClearCaptions’ Sr. Legal Counsel to ensure overall alignment on high-risk legal matters. - Advises on and ensures adherence to applicable local, state, and federal regulations affecting the organization. - Manages the Company’s Consumer focused policies and agreements including the Privacy Policy, CCPA, DOPPA and Terms of Use agreements. - Monitors changes to legislation and regulatory guidance and assesses their impact on organization’s policies and operations of ClearWellness. - Advises on Medicare and Medicaid DME supplier enrollment, accreditation (ACHC/The Joint Commission), and competitive bidding program requirements under 42 C.F.R. Part 414. - Interprets and applies CMS Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs) relevant to PERS and DME product lines. - Advises on Anti-Kickback Statute (AKS), Stark Law, and False Claims Act (FCA) exposure in referral, marketing, and reimbursement arrangements. - Support product development and launch teams with regulatory pathway analysis, labeling review, and promotional material approval for new PERS devices. - Advises on privacy and data security obligations arising from PERS devices and monitoring platforms, including the intersection of PERS data with HIPAA Privacy and Security Rules where PHI is involved. - Counsels operational teams on liability, informed consent, and disclosure obligations related to PERS program deployment and emergency response protocols. - Assists in developing internal policies and procedures governing DME/PERS program operations, incident response, and user rights. - Performs other duties as assigned. Qualifications - A Juris Doctor degree is required. - Bar admission, in good standing, licensed to practice in one or more states. - A minimum of seven (7) years of combined experience in a law firm and/or as in-house counsel is required. - Previous Experience as a HIPAA Compliance Officer. - Deep understanding of HIPAA regulations, including Privacy Rule, Security Rule, and Enforcement Rule. - Strong analytical and problem-solving skills to identify and address potential compliance risks. - Demonstrated ability to lead through influence, including mentoring others, leading initiatives or workstreams, contributing to best practices, and driving cross-functional outcomes. - Excellent communication and interpersonal skills to effectively train staff and collaborate with stakeholders. - Self-starter with strong organizational and time management skills, self-directed and able to handle multiple priorities with demanding timeframes. - Ability to work collaboratively with colleagues and staff to create a high-quality results-driven, team-oriented environment. - Demonstrated ability to use discretion, make sound decisions, and maintain confidentiality. - Willingness and ability to work flexible hours as needed, and travel up to 10%, which may include occasional overnight travel. - Proficiency in Microsoft Office Suite and modern communication tools for virtual teams (e.g., Microsoft Teams, Slack). Preferred - Experience implementing a HIPAA compliance program from start to finish. - Experience with Personal Emergency Response Systems (PERS), including legal oversight of PERS vendor relationships, device data privacy, and regulatory compliance. - ISO 13485:2016 Medical Devices and 21 CFR 820 experience. - Experience with telehealth, remote patient monitoring (RPM), or connected medical device platforms. - Prior in-house healthcare legal or compliance experience at a DME supplier, PERS company, or home health organization. - General health care related compliance programs. Physical Demands In accordance with the Americans with Disabilities Act (ADA) and applicable state and local laws, the Company will provide reasonable accommodations to qualified individuals with documented disabilities to enable them to perform the essential functions of the job, unless such accommodations would impose an undue hardship. Employees seeking accommodation should contact the People Department to initiate the interactive process. - Sitting, standing, and walking (95-100%) - Keyboarding (40-60%) - Viewing computer monitor, tablet, and cell phone requiring close vision (95-100%) Work Environment 100% Remote with Travel: Work environment is primarily indoors (home office, customer of vendor sites, or other business meeting venues); travel may involve exposure to varying weather and temperature conditions, as well as driving and traffic hazards. Travel is required, approximately 10%, and may include overnight and out-of-state trips. Compensation $165,000 to $200,000/yr plus 18% bonus determined by competitive market analysis and internal equity considerations. Final compensation will be based on the candidate’s qualifications, experience, and business needs. For details on our comprehensive benefits program, visit www.clearcaptions.com/careers to explore our total rewards package. Intrigued to learn more? When you apply for this role, your information will be personally reviewed by our talent acquisition team (not by a robot). You can expect to hear back from us if we think there could be a fit and what next steps look like. Disclaimer The above information in this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. ClearCaptions does not offer sponsorship for work authorization. Candidates must be authorized to work for any employer in the US without a current or future need for Visa sponsorship. Protecting Your Candidate Experience At ClearCaptions, your candidate experience matters to us. To ensure transparency and security throughout the hiring process, please keep the following in mind: - All legitimate ClearCaptions job openings are posted exclusively on this careers page. - Our recruiters will only contact you from verified @clearcaptions.com email addresses. - We will never offer a job through LinkedIn messages or any social media platform. - We will never ask for sensitive personal information (like banking details or Social Security numbers) during early stages of the hiring process. - We encourage all applicants to stay vigilant against online job scams, especially those that misuse company names or logos to appear legitimate. If you receive a message that seems suspicious or doesn’t follow these guidelines, please don’t engage. You’re welcome to verify any opportunity by reaching out to us directly at recruiting@clearcaptions.com.

• Responsible to establish and maintain a group of high performing regulatory affairs professionals. • Closely collaborate with regional regulatory expertise in the Therapeutic Areas in both labelling and CMC aspects. • Design, deploy and maintain processes to manage external stakeholders. • Provide regulatory support, including oversight of product launch and implementation timelines. • Accountable for planning, leading and delivering Hong Kong registration strategies across a broad range of company products.

• Serve as a senior advisor to clients on FDA regulatory expectations, inspection strategy, and compliance risk mitigation • Lead inspection readiness and mock inspection programs, helping clients prepare with confidence • Apply firsthand FDA knowledge to anticipate inspection findings and proactively address gaps • Advise on and support response strategies for: Form FDA 483 observations, Warning letters, Import alerts, Regulatory meetings, Consent decrees and enforcement actions • Guide clients through root cause analysis, remediation planning, and sustainable compliance solutions • Provide expertise in risk-based decision-making, including regulatory discretion and supply continuity • Collaborate across cross-functional teams to support complex quality and regulatory engagements • Mentor team members and contribute to building internal expertise • Engage in client discussions and contribute to business development efforts