1,723 Regulatory jobs in the United States

Overview

Vice President / Senior Vice President - Regulatory Affairs
U.S. - Remote or Hybrid (Bay Area) | Full-time
Salary Range: $380,000 - $430,000 + Bonus + Equity

Lead the regulatory strategy behind a new era of precision medicine. This is a rare opportunity to join a clinical-stage biotech company that's redefining how rare and genetic diseases are treated. As VP/SVP of Regulatory Affairs, you'll be the architect of global regulatory strategy—guiding breakthrough therapies from development to approval and beyond. If you're ready to lead with purpose and build something transformative, this is the move worth making.

• Strategic Ownership : You'll lead all aspects of regulatory strategy across a growing pipeline of high-impact programs.
• Executive Visibility : Work directly with the C-suite and Board to shape development timelines, regulatory positioning, and global launch readiness.
• Patient-Centered Mission : Your leadership will accelerate access to therapies for underserved populations with urgent medical needs.
• Global Reach : Influence regulatory pathways across the U.S., EU, and other key markets.

• 15+ years in Regulatory Affairs, with deep experience in clinical-stage biotech
• Proven success leading INDs, CTAs, BLAs/MAAs, and global regulatory interactions
• Strong leadership and communication skills, with the ability to influence internal and external stakeholders
• Experience building and scaling regulatory teams and infrastructure
• A strategic mindset and passion for solving complex regulatory challenges

• Develop and execute global regulatory strategies across multiple therapeutic programs
• Serve as the primary liaison with health authorities, leading key interactions and submissions
• Build and mentor a high-performing regulatory team
• Partner cross-functionally to align regulatory strategy with clinical, CMC, and commercial goals
• Monitor evolving regulatory landscapes and proactively adapt strategy

• Executive Leadership : A seat at the table where your voice shapes company direction and patient impact.
• Competitive Compensation : Strong base salary, performance bonus, and meaningful equity participation.
• Comprehensive Benefits : Health coverage, 401(k) match, stock purchase plan, generous PTO, paid parental leave, and more.
• Mission-Driven Culture : Join a team united by a shared purpose—delivering transformative therapies to patients who need them most.

Join to apply for the Manager Regulatory Affairs role at InspireMD

We are seeking a highly experienced and motivated Manager, Regulatory Affairs, to join our growing Regulatory Affairs team in Miami. This role is critical to ensuring compliance with US regulatory requirements and supporting the development, approval, and lifecycle management of medical devices. The ideal candidate will possess deep expertise in U.S. FDA regulations, and have a good general understanding of EU MDR, and international standards, and will contribute to strategic regulatory planning and execution.

• Lead regulatory strategy and submissions for Class II and III medical devices in the U.S.
• Prepare and manage regulatory submissions including 510(k), PMA Supplements, annual reports
• Serve as the US regulatory lead on cross-functional project teams, ensuring alignment with clinical, quality, and R&D functions.
• Interpret and apply regulatory requirements to product development, labeling, and review of advertising and promotional materials.
• Monitor changes in regulatory requirements and communicate impact to internal stakeholders.
• Support audits and inspections by regulatory authorities.
• Lead post-market regulatory assessments and submissions, including periodic reports, vigilance reporting, and regulatory renewals.
• Manage complaint handling activities, ensuring timely investigation, documentation, and regulatory reporting in compliance with applicable standards.

• Bachelor’s degree in engineering, life sciences, pharmacy, or related field. Advanced degree preferred.
• Minimum 10 years of experience in regulatory affairs within the medical device industry.
• Proven track record of successful submissions to FDA
• In-depth knowledge of FDA 21 CFR 820, ISO 13485, and other applicable standards.
• Strong communication, leadership, and project management skills.
• Experience with eQMS systems and electronic document control preferred.

• Mid-Senior level

• Full-time

• Legal

• Medical Device

Overview

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO .

Location: Bellevue, WA. Compensation information provided in the original listing.

• Support and advise cross-functional teams and communicate APAC regulatory requirements and challenges effectively to meet project needs and company objectives.
• Oversee and direct the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of regulatory documentation for new products, amendments of approved products, and submissions that support the maintenance of existing licenses.
• Support the implementation of policies, procedures, practices, and strategies to facilitate support of in-country product registrations in APAC.
• Work closely with the regional APAC regulatory team to develop and drive process efficiencies for APAC regulatory submissions.
• Review and evaluate issues that may create regulatory or business obstacles and propose solutions.
• Monitor APAC regulations/guidelines and the impact of changing/evolving regulations on submissions, practices, and procedures, and communicate to appropriate stakeholders.
• Manage the performance and career development of direct reports.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree required, 5 years direct experience in Regulatory Affairs in a Medical Device Company required.
• Knowledge and Skill Requirements/Specialized Courses and/or Training.
• Strong interpersonal and communication skills.
• Proficient in Microsoft Office.
• Advanced written communication skills.

The listing includes standard statements about reasonable accommodations for applicants with disabilities and general workplace expectations.

Responsibilities

• The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.
• Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams.
• Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
• Document regulatory strategies for product submissions.
• Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays.
• Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays.
• Facilitate FDA pre-submission meetings.
• Support EU representatives in their creation of CE/IVD Technical Files.
• Support global regulatory registration representatives for product registration activities.
• Perform regulatory assessment of new and changed products.
• Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment.
• Participate in business meetings with potential new external partners.
• Assist the Regulatory department in updating, improving, and crafting internal policies and procedures.

• B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science at least 5 years of IVD Regulatory Affairs experience.
• Hands-on experience with 510(k), PMA, and PMA supplement submissions.
• Knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
• Ability to lead multiple projects and meet deadlines.
• Strong communication and teamwork skills.
• Capacity to communicate regulations to technical functions within the company.
• Experience as the RA representative on project core teams.

Overview

In this critical role, you will lead regulatory strategies, product submissions, and a team of 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.

• 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.

Join to apply for the Regulatory Affairs Associate role at Katalyst CRO

• Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
• Provides regulatory support for diagnostic product development and commercial diagnostic products.
• Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally.
• Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
• Researches and communicates scientific and regulatory information to write submission documents.
• Compiles and publishes all material required for submissions, license renewals, and annual registrations.
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
• Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
• Develops internal procedures and tools.
• Conducts informational or training sessions for stakeholders.
• Organizes and maintains hard copy and electronic department files.
• Demonstrates commitment to the development, implementation, and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

• Bachelor's degree in biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
• 4+ years' experience in Regulatory Affairs role.
• Strong knowledge of IVDR and EU regulatory requirements is required.
• Good knowledge of EU and international regulations.
• Demonstrated written and verbal communication skills.
• Strong time management skills, with the ability to work on multiple projects simultaneously.
• Ability to work independently as well as within a team.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio.

Overview

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Specific Education & Experience Requirements:

• 5+ years of experience in Regulatory Affairs or other relevant industry experience.
• Degree in a scientific field is preferred.

• Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations, original, marketing authorization applications for territories other than the US and EU and for contributing to preparation of US and EU marketing authorizations.
• Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics.
• Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling.
• May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.
• Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects.
• Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.
• Initiates or contribute to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
• Excellent organization skills and ability to work on a number of projects with tight timelines is required.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories. Is recognized as a knowledgeable resource within the department on a range of topics.
• Work is performed under minimal direction of a senior Regulatory Affairs professional.

The salary range for this position is:

• Bay Area: $146,540.00 - $89,640.00
• Other US Locations: 133,195.00 - 172,370.00

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit the URL below.

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the Know Your Rights poster. For jobs in the United States, Gilead also provides information about other policies and notices.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday for current Gilead employees and contractors.

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.

• 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.

• 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.

• 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.

$65,000 - 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.

BioPhase is seeking a Regulatory Affairs Manager to lead regulatory strategy and compliance for in vitro diagnostic (IVD) products. This role oversees regulatory submissions, market authorizations, and agency communications, ensuring compliance with FDA, EU IVDR, and global regulations. The ideal candidate will collaborate cross-functionally and drive regulatory excellence.

Responsibilities

• Develop and execute global regulatory strategies for IVD products.
• Lead preparation of 510(k), IVDR Technical Documentation, and other regulatory submissions.
• Manage regulatory assessments for product changes and compliance.
• Collaborate with R&D, Quality, Manufacturing, and Marketing teams.
• Mentor and lead a team of regulatory professionals.
• Monitor global regulatory trends and implement best practices.
• Support regulatory inspections and audits.

Qualifications

• Bachelor’s degree in Bioengineering, Biochemistry, Molecular Biology, or related field (Advanced degree preferred).
• 8+ years in Regulatory Affairs, with 5+ years in IVD regulatory roles.
• Experience securing approvals in US, EU IVDR, Canada, Australia, etc.
• Strong leadership and cross-functional collaboration skills.
• Proficiency in regulatory submission tools and Microsoft Office Suite.
• Limited travel (

Regulatory Manager • San Diego, CA, US

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