1,393 State Licensure jobs in the United States

We are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are passionate about regulatory affairs and looking for an opportunity to grow within a dynamic company, we encourage you to apply.

Responsibilities:

• Prepare, review, and submit regulatory documents to ensure compliance with FDA and other regulatory authorities.
• Maintain up-to-date knowledge of regulations, guidelines, and standards relevant to the pharmaceutical industry.
• Assist in the preparation of regulatory submissions including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and amendments.
• Coordinate with cross-functional teams to gather necessary information for regulatory submissions.
• Ensure timely and accurate communication with regulatory authorities.
• Monitor and track the progress of submissions and respond to any inquiries from regulatory bodies.
• Assist in the development and implementation of regulatory strategies to support product approvals and lifecycle management.
• Maintain accurate and organized regulatory files and records.

• Bachelor's degree in a related field such as biology, chemistry, or pharmaceutical sciences.
• Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred.
• Strong understanding of FDA regulations and guidelines.
• Excellent organizational and time management skills.
• Strong attention to detail and ability to handle multiple projects simultaneously.
• Effective communication skills, both written and verbal.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and as part of a team.

• Manages confidential information within the department and related involved employees, patients, visitors, and/or physicians.
• Responsible for the organization-wide oversight and resolution of regulatory and hospital licensure matters including survey preparation, process changes, new requirements, and compliance with all regulatory standards required for patient safety and quality of care and services.
• Provide organizational support to the Corporate Director of Regulatory Affairs to ensure effective communication and oversight of the organizational responses to unannounced regulatory visits and inspections and timely completion and submission of licenses, applications, certification, and accreditation documentation.
• Assist facility in preparations for surveys (i.e., State, The Joint Commission, Center for Medicare and Medicaid Services, AHCA), conducts quality and patient safety surveys, and ensures continuous readiness for State and Federal surveys.
• Lead or organize tracers/ mock surveys with the interdisciplinary team to assess, drive, and maintain continuous survey readiness, communicate findings and concerns, and follow up on action plans across the organization.
• Participate in organization-wide committees and administrative meetings of various departments and campuses as necessary to address regulatory standards or concerns and relate information to various disciplines as appropriate.
• Collaborates with Risk Management in the facilitation of root cause analysis (RCA), failure mode and effects analysis (FMEA) and monitoring of action plan implementation.
• Serve as a liaison with various regulatory agencies and entities for matters on program/ hospital/ system wide accreditation and licensure and/ or certifications.
• Collaborate with the leadership at different levels throughout the organization in establishing and prioritizing goals and actions, process improvements on deficiencies and significant findings relevant to patient safety and quality of care.
• Coordinates the development of data collection tools and review of data.
• Lead, coordinate, investigate, and respond to complaint and/or quality concerns received via Federal and State agencies and related entities.
• Collaboration with Risk Management in relation to incidents that may result in regulatory visits and/or sentinel event reporting.
• Maintain regulatory and other hospital survey readiness and compliance data collection systems with oversight of audit tools and results for continuous compliance and develop statistical and qualitative reports on monthly/quarterly basis to critically oversee the organization's adherence to compliance indicators and target goals.
• Promotes the performance improvement, patient satisfaction and employee satisfaction as goals of the organization.
• Serve as a resource to the organization for interpretation of standards of regulatory and accrediting agencies and provide support in the communication and integration towards the mission and vision of the organization to all staff.
• Performs other related duties as assigned.
• Makes recommendations for improvement and monitors status of resolution regarding identified issues, as appropriate.
• Maintains strict confidentiality of all information discovered in the review process.
• Interprets and evaluates clinical data, identifies variations in care/deviation from standards based on specific criteria determined by TJC and CMS. Develops TJC preparation timelines and follows-up to successfully meet survey goals.
• Maintains, utilizes and communicates current knowledge of regulatory agency requirements, and standards.
• Role models behaviors of service excellence and CARE values (Compassion, Accountability, Respect and Expertise).
• The leader understands and adheres to JHS compliance standards as they appear in the Code of Conduct, Compliance Policies, and all other JHS Policies and Procedures and supports the commitment of JHS in adhering to federal, state and local laws, rules and regulations governing ethical business practices for health care providers by demonstrating knowledge of procedures for protecting and maintaining security, confidentiality and integrity of employee, patient, family and organization information.
• The leader further understands that JHS is committed to its role in preventing health care fraud and abuse and complying with applicable state and federal laws related to health care fraud and abuse.
• This commitment is supported and enabled through an anonymous hotline which serves as one of several mechanisms for reporting suspected fraud, waste and/or abuse, as well as other compliance related issues.
• The leader to report through any of the reporting mechanisms (e.g., anonymous hotline, supervisor, Compliance Officer) any suspected health care fraud, waste and/or abuse as well as other compliance-related issues.
• Performs all other related job duties as assigned.

Join to apply for the Manager, Regulatory Affairs role at Baylor College of Medicine Summary The Regulatory Affairs Manager provides analytical, regulatory, and supervisory support for the clinical research/regulatory team at The Center for Cell and Gene Therapy (CAGT). This includes training and supervising regulatory staff, helping investigators develop regulatory strategies, and analyzing regulatory changes affecting CAGT protocols. The Manager works closely with the Director to oversee all aspects of clinical research within CAGT. The role is fast-paced and high-profile, requiring strong concentration, understanding of complex scientific concepts, and multitasking skills. The ideal candidate will be highly organized, intelligent, motivated, and possess strong problem-solving skills. The position offers a hybrid work schedule. Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certifications are eligible for certification pay. Job Duties Maintain knowledge of federal regulations, institutional policies, and ICH GCP guidelines to guide regulatory staff and investigators in compliance. Confirm the content of regulatory submissions. Collaborate with regulatory staff and investigators on protocol documents and consent forms, and respond to queries from review committees and agencies like the FDA. Submit and maintain required documents. Assist in preparing for FDA meetings, inspections, and audits. Maintain systems to communicate regulatory changes and protocol-specific information to relevant parties. Ensure all clinical research projects remain compliant and are properly documented. Supervise a team of regulatory professionals. Perform additional duties as assigned. Minimum Qualifications Bachelor's degree. Four years of relevant experience. Preferred Qualifications Master's degree. Five years in regulatory affairs or compliance. Experience working with the FDA. Oncology, Cell, and Gene therapy experience. Project management skills. Strong computer and organizational skills. Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer. Additional Details Seniority level: Mid-Senior level Employment type: Full-time Job function: Research Industry: Higher Education Location: Houston, TX Salary Range: $103,000 - $139,000 Note: The job posting is recent and active. No indication of expiration is present. #J-18808-Ljbffr

The Director of Regulatory Affairs will lead Pano AI's engagement with utility regulators, public utility commissions (PUCs), and other key regulatory and policy stakeholders at the state and federal levels. This role focuses on shaping a favorable regulatory environment for wildfire detection technology and accelerating market adoption through strategic regulatory advocacy and collaboration with Pano's utility sales team. Pano AI is the utility sector leader in rapid detection and situational awareness this role is crucial to the company's continued growth in the sector.

This position is new and requires both strategic leadership and hands-on execution. Reporting to the VP for Global Government Affairs and working closely with the utility practice, it blends policy advocacy, regulatory strategy, stakeholder engagement, and business support, all aligned toward revenue growth and market transformation.

• Regulatory and Policy Strategy: Develop and execute a national and state-level regulatory strategy to promote the adoption of AI-enabled wildfire detection technology by electric utilities. Monitor, analyze, and engage with regulatory proceedings, dockets, and legislative developments relevant to wildfire mitigation, grid resilience, and rate recovery mechanisms. Advise internal leadership on emerging regulatory risks and opportunities affecting Pano's utility business.
• Advocacy and External Engagement: Build and maintain trusted relationships with public utility commissioners, regulatory staff, consumer advocates, trade associations, and other policy stakeholders. Lead preparation and submission of written comments, testimony, and filings in regulatory proceedings. Represent Pano AI at hearings, workshops, and conferences; participate in relevant industry working groups and coalitions. Position Pano as a thought leader on wildfire detection and grid resilience policy issues.
• Sales and Commercial Support: Act as a regulatory resource and partner to Pano's Utility Sales team during customer engagement, RFP processes, and negotiations. Provide strategic insights on cost recovery pathways, regulatory approval processes, and relevant policy drivers impacting utility purchasing decisions. Support sales teams with customer education materials, regulatory position papers, and responses to regulatory-related questions from utility clients.
• Cross-Functional Leadership: Work closely with Government Affairs, Product, Engineering, Legal, and Marketing to ensure regulatory trends and customer needs are integrated into product roadmaps and corporate strategy. Help develop public messaging and thought leadership content that advances Pano's policy objectives.

• 812+ years of experience in regulatory affairs, energy policy, utility operations, or related fields.
• Direct experience engaging with state Public Utility Commissions and/or federal energy regulators.
• Track record of successful regulatory advocacy, including comment filings, testimony, or policy wins.
• Experience working in or with investor-owned utilities, utility regulators, or technology vendors serving the utility sector.
• Strong knowledge of utility regulatory frameworks, including rate-making, cost recovery, and grid safety regulation. Direct experience in wildfire planning a plus.
• Excellent written and verbal communication skills; able to distill complex technical and policy topics into compelling, accessible narratives.
• Ability to develop trusted relationships with both regulatory bodies and commercial teams.
• High business acumen with a strong understanding of how regulatory issues drive revenue and market expansion.

• Familiarity with wildfire mitigation planning processes, PSPS protocols, etc.
• Experience working at a tech company serving the utility sector, for a Public Utility Commission, or within a utility's regulatory affairs team.
• Understanding of the intersection between AI/technology solutions and public safety infrastructure.
• Entrepreneurial mindset and comfort working in a fast-growing, mission-driven technology company.

$165,000 - $200,000 a year. Final salary offered is based upon multiple factors, including individual job-related qualifications, education, experience, knowledge, skills and location. In addition to salary, this position is also eligible for stock options. We offer comprehensive medical, dental and vision insurance, unlimited paid time off, and matching 401k.

Pano is an equal opportunity employer committed to recruiting and supporting our team-members regardless of where they come from. We do not discriminate on the basis of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Who we are The problem: Every minute matters in fire response. As climate change amplifies the intensity of wildfires—with longer fire seasons, dryer fuels, and faster winds—new ignitions spread faster and put more communities at risk. Today, most wildfires are detected by bystanders and reported via 911, meaning it can take hours to detect a fire, verify its exact location and size, and dispatch first responders. Fire authorities need a faster way to detect, confirm, and pinpoint fires so that they can quickly respond—preventing small flare-ups from becoming devastating infernos. About Pano: We are a 100+ person growth-stage hybrid-remote start-up, headquartered in San Francisco. We are the leader in early wildfire detection and intelligence, helping fire professionals respond to fires faster and more safely—with the right equipment, timely information, and enhanced coordination—so that they can stop a new ignition before it grows. Pano AI combines advanced hardware, software, and artificial intelligence into an easy-to-use, web-based platform. Leveraging a network of ultra-high-definition, 360-degree cameras atop high vantage points, as well as satellite and other data feeds, Pano AI produces a real-time picture of threats in a geographic region and delivers immediate, actionable intelligence. Pano AI is on TIME 's list of the 100 Most Influential Companies of 2025! MIT Technology Review listed Pano as one of the top 15 climate tech companies to watch in 2024, and Fast Company named Pano AI one of the Top 10 most innovative companies in AI of 2023 . We’ve also been featured in the Wall Street Journal , Bloomberg , and CNBC News . Pano AI’s dozens of government and enterprise customers span 16 states in the U.S., five states in Australia, and BC, Canada, and we are currently monitoring over 30 million acres of land. Pano AI has raised $89M in venture capital funding from Giant Ventures, Liberty Mutual Ventures, Tokio Marine Future Fund, Congruent Ventures, Initialized Capital, Salesforce Ventures, and T-Mobile Ventures. Learn more at . The Role The Director of Regulatory Affairs will lead Pano AI’s engagement with utility regulators, public utility commissions (PUCs), and other key regulatory and policy stakeholders at the state and federal levels. This role focuses on shaping a favorable regulatory environment for wildfire detection technology and accelerating market adoption through strategic regulatory advocacy and collaboration with Pano's utility sales team. Pano AI is the utility sector leader in rapid detection and situational awareness – this role is crucial to the company’s continued growth in the sector. This position is new and requires both strategic leadership and hands-on execution. Reporting to the VP for Global Government Affairs and working closely with the utility practice, it blends policy advocacy, regulatory strategy, stakeholder engagement, and business support, all aligned toward revenue growth and market transformation. What you’ll do Regulatory and Policy Strategy: 1.Develop and execute a national and state-level regulatory strategy to promote the adoption of AI-enabled wildfire detection technology by electric utilities. 2. Monitor, analyze, and engage with regulatory proceedings, dockets, and legislative developments relevant to wildfire mitigation, grid resilience, and rate recovery mechanisms. 3. Advise internal leadership on emerging regulatory risks and opportunities affecting Pano’s utility business. Advocacy and External Engagement: 1. Build and maintain trusted relationships with public utility commissioners, regulatory staff, consumer advocates, trade associations, and other policy stakeholders. 2. Lead preparation and submission of written comments, testimony, and filings in regulatory proceedings. 3. Represent Pano AI at hearings, workshops, and conferences; participate in relevant industry working groups and coalitions. 4. Position Pano as a thought leader on wildfire detection and grid resilience policy issues. Sales and Commercial Support: 1.Act as a regulatory resource and partner to Pano’s Utility Sales team during customer engagement, RFP processes, and negotiations. 2. Provide strategic insights on cost recovery pathways, regulatory approval processes, and relevant policy drivers impacting utility purchasing decisions. 3. Support sales teams with customer education materials, regulatory position papers, and responses to regulatory-related questions from utility clients. Cross-Functional Leadership: 1.Work closely with Government Affairs, Product, Engineering, Legal, and Marketing to ensure regulatory trends and customer needs are integrated into product roadmaps and corporate strategy. 2. Help develop public messaging and thought leadership content that advances Pano’s policy objectives. What you’ll bring 8–12+ years of experience in regulatory affairs, energy policy, utility operations, or related fields. Direct experience engaging with state Public Utility Commissions and/or federal energy regulators. Track record of successful regulatory advocacy, including comment filings, testimony, or policy wins. Experience working in or with investor-owned utilities, utility regulators, or technology vendors serving the utility sector. Strong knowledge of utility regulatory frameworks, including rate-making, cost recovery, and grid safety regulation. Direct experience in wildfire planning a plus. Excellent written and verbal communication skills; able to distill complex technical and policy topics into compelling, accessible narratives. Ability to develop trusted relationships with both regulatory bodies and commercial teams High business acumen with a strong understanding of how regulatory issues drive revenue and market expansion. Preferred Attributes Familiarity with wildfire mitigation planning processes, PSPS protocols, etc. Experience working at a tech company serving the utility sector, for a Public Utility Commission, or within a utility’s regulatory affairs team. Understanding of the intersection between AI/technology solutions and public safety infrastructure. Entrepreneurial mindset and comfort working in a fast-growing, mission-driven technology company. Final salary offered is based upon multiple factors, including individual job-related qualifications, education, experience, knowledge, skills and location. In addition to salary, this position is also eligible for stock options. We offer comprehensive medical, dental and vision insurance, unlimited paid time off, and matching 401k. Pano is an equal opportunity employer committed to recruiting and supporting our team-members regardless of where they come from. We do not discriminate on the basis of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. #J-18808-Ljbffr

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Manager role at Katalyst CRO In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions. Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management. Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies. Oversee and coach a team of regulatory professionals to support both strategic and operational objectives. Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.). Define and execute submission strategies to meet timelines and business goals. Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review. Monitor changes in international regulatory environments and communicate impacts to internal teams. Represent the company in industry groups or regulatory associations, where appropriate. Support training and knowledge-sharing on country-specific regulatory requirements within the organization. Responsibilities In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions. Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management. Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies. Oversee and coach a team of regulatory professionals to support both strategic and operational objectives. Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.). Define and execute submission strategies to meet timelines and business goals. Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review. Monitor changes in international regulatory environments and communicate impacts to internal teams. Represent the company in industry groups or regulatory associations, where appropriate. Support training and knowledge-sharing on country-specific regulatory requirements within the organization. Requirements BS/MS degree or equivalent experience required. Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR. Superior presentation skills when communicating with all levels of the organization, business partners, and external sources. Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment. Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations. Seniority level Seniority level Associate Employment type Employment type Contract Job function Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Regulatory Affairs Manager” roles. Investigator, Ethics and Business Integrity, North America Cambridge, MA $125,250.00-$80,916.66 1 week ago Greater Boston 150,000.00- 175,000.00 3 weeks ago Waltham, MA 215,000.00- 245,000.00 2 weeks ago Director, Corporate Compliance, North America Director of Corporate Compliance & Risk Management Boston, MA 100,000.00- 136,000.00 1 month ago Boston, MA 70,000.00- 75,000.00 5 days ago Boston, MA 114,400.00- 153,300.00 3 weeks ago Boston, MA 84,000.00- 126,000.00 2 weeks ago Waltham, MA 129,000.00- 162,000.00 5 days ago Marlborough, MA 191,200.00- 239,000.00 1 week ago Director of Monitoring, Ethics and Business Integrity Cambridge, MA 148,125.00- 213,958.33 1 week ago Boston, MA 125,000.00- 155,000.00 5 days ago Boston, MA 135,000.00- 165,000.00 13 hours ago Senior Compliance Officer – Marketing Review Boston, MA $1 0,000.00- 175,000.00 2 weeks ago Associate Director, PSPV Compliance & Analyticsl We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr