AliveCor

Senior Regulatory Affairs Specialist

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AliveCor, a pioneer in over-the-counter medical EKG devices, is seeking a Senior Regulatory Affairs Specialist. This role involves overseeing medical device development and market introduction, managing product submissions, performing regulatory analysis, driving worldwide product registrations, and maintaining an ISO 13485 and FDA compliant Quality Management System. The specialist will collaborate with cross-functional teams to ensure compliance and drive change in mobile health.

<h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Description</h3>At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting.AliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and Sales teams to manage product submissions, perform regulatory pre- and post-market analysis, drive product registrations and listings worldwide, and help implement and maintain an ISO 13485 and FDA compliant Quality Management System. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you.Role & Responsibilities<ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Collaborate and execute regulatory strategies for US, Europe and other global registrations</li><li class="leading-relaxed">Participate in preparation and review of global regulatory submissions</li><li class="leading-relaxed">Support government/FDA interactions pertaining to medical device registrations and licensing;</li><li class="leading-relaxed">Participate in the development of regional regulatory strategy and update strategy based upon regulatory changes;</li><li class="leading-relaxed">Assist in the review of advertising and promotional materials;</li><li class="leading-relaxed">Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle;</li><li class="leading-relaxed">Support or lead regulatory activities required for US FDA, EU MDR, NMPA, PMDA, ANVISA compliance;</li><li class="leading-relaxed">Support worldwide resellers and distributors with product registrations and renewals;</li><li class="leading-relaxed">Provide regulatory assessment for manufacturing and design changes;</li><li class="leading-relaxed">Provide regulatory review and approval of change order packets;</li><li class="leading-relaxed">Support or lead product regulatory intelligence and risk assessments;</li><li class="leading-relaxed">Assist in maintaining compliance with product post market requirements;</li><li class="leading-relaxed">Support post-market regulatory actions taken for the products;</li><li class="leading-relaxed">Support internal and external audits;</li><li class="leading-relaxed">Ensure compliance with internal procedures and external regulations and standards;</li><li class="leading-relaxed">Maintain regulatory and quality records and other controlled documents; and</li><li class="leading-relaxed">Promote a culture of quality throughout AliveCor</li></ul>Requirements<ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Bachelors degree in Science, Engineering, Math, or medical field or equivalent educational experience pertaining to technical writing, scientific method, and problem solving</li><li class="leading-relaxed">4+ years of experience in medical device Regulatory Affairs</li><li class="leading-relaxed">Experience in regulatory affairs for software devices with AI/machine learning algorithms (SaMD)</li><li class="leading-relaxed">Participated in the preparation of pre-submissions, 510(k)s or de novo submissions</li><li class="leading-relaxed">Experience with and knowledge of EU Medical Device Regulations</li><li class="leading-relaxed">Ability to manage small projects: organised, independent, and results-oriented</li><li class="leading-relaxed">Superb analytical and excellent communication skills, strong team ethic, and attention to detail</li></ul>Preferred candidate profile<ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Advanced degree or Regulatory Affairs Certification from RAPS</li><li class="leading-relaxed">Process-oriented thinking</li><li class="leading-relaxed">Supported or lead international submissions (preferably in Asia-Pacific and/or LATAM)</li><li class="leading-relaxed">Demonstrated competence documenting technical information and communicating it to others</li></ul>Perks and benefitsWe strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen.<ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Hybrid working model</li><li class="leading-relaxed">Flexible and generous vacation policy</li><li class="leading-relaxed">Maternity / Paternity Leave/ Adoption/ Commissioning leave</li><li class="leading-relaxed">Generous Medical Benefits Above market family floater medical insurance coverage including both parents or in law parents</li><li class="leading-relaxed">Metro connectivity from office</li><li class="leading-relaxed">A supportive, collaborative group of people who understand that success depends on the team</li></ul>AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any other classification protected by federal, state, or local law.

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Toast is seeking a seasoned Engineering Manager for the Toast Now team, focusing on delivering native mobile app experiences for restaurant managers and operators. This role involves leading a high-performing, agile, and customer-focused team to build innovative products using modern mobile technologies. The manager will drive business outcomes, collaborate with PM and UX, ensure software quality, and hire and develop team members, empowering operators to manage their business in real-time.

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Toast is driven by building the restaurant platform that helps restaurants adapt, take control, and get back to what they do best: building the businesses they love.We are seeking a seasoned Engineering Manager for Toast Now - the team putting the power of the entire Toast platform into the pockets of restaurant managers and operators. Our goal is to deliver native app experiences that empower restaurant operators to manage their business in real-time, whether from the restaurant floor, the back office, or their couch at home.We're delivering an innovative new product on modern mobile technologies. Our teams are very agile and extremely customer-focused. UX, PM, and software engineers work hand-in-hand every day, and teams get feedback directly from pilot customers. We have high standards for customer satisfaction, and we strive to deliver high quality features in rapid iterative cycles.The talent density on this team is high with low homogeneity - folks drive impact and value differently, and we’re looking for a seasoned individual to lead such a high performing team.<h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">About this roll\* (Responsibilities) :</h3><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Drive delivery of business outcomes, including planning, schedule, and execution</li><li class="leading-relaxed">Drive cross-team and cross-organization efforts with predictable results and excellent collaboration</li><li class="leading-relaxed">Collaborate closely with PM and UX to fill the teams’ backlog with actionable, valuable work</li><li class="leading-relaxed">Ensure end-to-end quality and delivery of software, including ownership of monitoring and production issues</li><li class="leading-relaxed">Hire and develop new team members</li><li class="leading-relaxed">Coach individuals in professional and technical development</li></ul><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Do you have the right ingredients\*? (Requirements):</h3><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Experience leading and mentoring successful teams to drive predictable business results</li><li class="leading-relaxed">Experience delivering a high quality iOS and/or Android experience - both inside the app and across the native stack</li><li class="leading-relaxed">Experience managing a mix of core contributions & away team engagements</li><li class="leading-relaxed">Experience delivering products on technologies such as GraphQL and microservices</li><li class="leading-relaxed">Not afraid to get hands-on or go deep to help the team reach its goals - and you encourage high agency and exploring creative outlets</li><li class="leading-relaxed">A desire to build diverse teams that win together and prioritize customer success</li></ul><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">AI at Toast</h3>At Toast we’re Hungry to Build and Learn. We believe learning new AI tools empowers us to build for our customers faster, more independently, and with higher quality. We provide these tools across all disciplines, from Engineering and Product to Sales and Support, and are inspired by how our Toasters are already driving real value with them. The people who thrive here are those who embrace changes that let us build more for our customers; it’s a core part of our culture.<h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Our Spread\* of Total Rewards</h3>We strive to provide competitive compensation and benefits programs that help to attract, retain, and motivate the best and brightest people in our industry. Our total rewards package goes beyond great earnings potential and provides the means to a healthy lifestyle with the flexibility to meet Toasters’ changing needs. Learn more about our benefits at <a href="https://careers.toasttab.com/toast-benefits" target="_blank" rel="noopener noreferrer" class="text-blue-600 hover:text-blue-800 hover:underline transition-colors duration-200">https://careers.toasttab.com/toast-benefits</a>.\*Bread puns encouraged but not requiredThe base salary range for this role is listed below. The starting salary will be determined based on skills and experience. In addition to base salary, our total rewards components include cash compensation (overtime, bonus/commissions, if eligible), benefits, and equity (if eligible).Pay Range$155,000—$248,000 USD<h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Diversity, Equity, and Inclusion is Baked into our Recipe for Success</h3>At Toast, our employees are our secret ingredient—when they thrive, we thrive. The restaurant industry is one of the most diverse, and we embrace that diversity with authenticity, inclusivity, respect, and humility. By embedding these principles into our culture and design, we create equitable opportunities for all and raise the bar in delivering exceptional experiences.<h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">We Thrive Together</h3>We embrace a hybrid work model that fosters in-person collaboration while valuing individual needs. Our goal is to build a strong culture of connection as we work together to empower the restaurant community. To learn more about how we work globally and regionally, check out: <a href="https://careers.toasttab.com/locations-toast" target="_blank" rel="noopener noreferrer" class="text-blue-600 hover:text-blue-800 hover:underline transition-colors duration-200">https://careers.toasttab.com/locations-toast</a>.Apply today!

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