Description Why join AliveCor ? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. We're on a mission to be the world’s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG 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, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that we’ve saved lives. Join us in our mission! The Opportunity AliveCor is the most clinically validated personal ECG technology, trusted and recommended by leading cardiology practices in the United States and around the world. We value research, working in collaboration with hospitals and research groups, and supporting internal research in artificial intelligence and machine learning. In your role as the Director of Marketing , you’ll be responsible for developing and leading overall marketing strategy, driving day-to-day marketing activities reaching a variety of target audiences and will work collaboratively with our media, product, B2B/B2C and analytics teams to continually innovate and optimize marketing initiatives within India and APAC. We’re looking for someone who is very hands on, detail-oriented and capable of working on multiple projects in parallel. This role requires the candidate to be based out of our office in Bangalore, India . Roles And Responsibilities Develop and lead full-funnel marketing strategy for B2B vertical in India. Drive qualified leads for India B2B sales team using strategic and targeted marketing initiatives that leverage healthcare industry best practices. Lead delivery of all B2B marketing initiatives spanning video, digital, email, website, print, conferences, and more. Develop sales enablement materials to support India enterprise sales team in converting top of the funnel leads. Work with Google and relevant platforms to ensure campaigns are optimised and driving website traffic and lead form completion conversion Manage presence on e-commerce platforms such as Amazon and Shopify, optimizing for lead generation, engagement and conversion Oversee, and track budgets for all digital media and effectiveness of media spend via ROAS Day-to-day oversight and management of our creative projects managed through internal resources and external agencies: including new project briefings, managing priorities and building out production schedules to ensure projects are delivered on message and on time.* Work closely with the global marketing team to ensure all communications are consistent with the overall brand and organisational standards. Work closely with the local India sales team for alignment on target audiences, lead generation opportunities, local healthcare and buyer behaviour dynamics, and to understand the overall competitive landscape. Qualifications And Skills 10+ years of B2B experience in a marketing role within the healthcare or technology field. Extensive project management experience with ability to lead projects beginning to end, seek feedback and consensus among stakeholders and a discipline for being highly organised. Exceptional written and verbal communications skills A proven track record of driving projects to completion A self-starter who knows what’s required to get stuff done A creative approach to problem solving, and the ability to problem-solve in real-time Success working cross-functionally and influencing teams A passion for AliveCor’s mission to help all people with chronic conditions live better and lead healthier lives A Bachelor’s degree in Marketing, Communications, Business or related field Perks And Benefits We 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. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team Show more Show less

Description Why join AliveCor? At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. We're on a mission to be the world’s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG 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, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that we’ve saved lives. Join us in our mission! Making the invisible visible. By harnessing the power of artificial intelligence, we’re advancing the practice of medicine for doctors and society. And we’re just getting warmed up. The Opportunity AliveCor is the most clinically validated personal ECG technology, trusted and recommended by leading cardiology practices in the United States and around the world. We value research, working in collaboration with hospitals and research groups, and supporting internal research in artificial intelligence and machine learning. In this role as Complaints Analyst , you will be part of the Quality team, responsible for ensuring that AliveCor products perform as intended and meet/exceed customer expectations. You will work closely with Quality, Regulatory, Engineering, Product Management, Clinical, and the Customer Service team to implement and maintain an ISO 13485 and FDA compliant Quality Management System, specifically in the area of Complaints Management and Post-Market Surveillance. If you have what it takes to drive change in the medical marketplace, then this is the opportunity for you. This role is on-site at our office located in Bangalore. Role And Responsibilities Manage the domestic and international product surveillance activities for medical devices, manufactured, marketed, and distributed by AliveCor. Utilize troubleshooting and problem-solving skills to investigate returned products. Engage with Customer Service, Engineering, Regulatory, Clinical, and our Contract Manufacturers, etc. to identify details related to complaint information and occurrence. Perform an initial assessment of complaints and evaluation of complaint codes. Evaluate, as needed, complaint documentation for completeness and consistency, and execute additional actions as necessary to close the complaint file. Evaluate all complaints that present as potential reportable events according to appropriate regulatory standards. Escalate to appropriate teams (Clinical, Regulatory, Legal, Engineering, etc.). as needed and collaborate with Regulatory on reporting of adverse events (MDRs, MDVs, etc.). Perform Good Faith Effort for returned products and to obtain required information for complaint assessment and evaluation. Develop, implement, and monitor suitable complaint investigation templates. Maintain procedures related to the complaints, post-market surveillance, returned product and related processes. Provide input to customer guides, online FAQs, etc. to improve customer experience. Support the generation of metrics for complaints trending. Participate in Risk Management activities as required based on input from complaints data, including identification of new failure modes. Support quality and regulatory reviews, inspections, and audits as required. Other duties to support the RAQA team as needed. Qualifications And Skills BS in Science or Engineering. 1-3 years’ experience in the Medical Device (or other regulated) industry, preferably in Quality or Regulatory. Lesser experience considered with Advanced Degree. Demonstrated competence documenting technical information and communicating it to others. Experience with appropriate domestic medical device regulations, requirements, and standards such as: FDA 21CFR Parts 820, ISO13485. Must be able to work under pressure to meet regulatory reporting time frames and company requirements. Ability to manage small projects: is organized, driven, and results-oriented. Demonstrates good judgment in selecting methods and techniques to acquire information and arrive at conclusions. Preferred Participation/leader in quality process improvement initiatives. Experience with ISO 14971. Knowledge of basic statistics and be able to understand, apply, analyze, synthesize and evaluate. ASQ certification (CQE/CQIA/CQT/CQPA or other comparable certification) desired. Perks And Benefits We strive to make your life outside work as smooth as possible while youre at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team Show more Show less

Description Why join AliveCor? At AliveCor, we imagine a healthier world powered by access to personalised 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 world’s 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. The Opportunity: AliveCor seeks a Quality System Specialist join this exciting start-up that is changing the face of mobile health. In this role, you will be responsible for the hands-on, day-to-day support of AliveCor’s Quality Management System (QMS) to ensure compliance to company procedures, FDA QSR, ISO 13485, EUMDR and other regulatory standards. Main duties include the processing and maintenance of all QMS-related documents and records, related to product design history files, CAPAs/NCs, training, external standards, suppliers, audits, and calibration. Additional responsibilities include supporting internal and external audits and quality improvement initiatives. This role requires the candidate to be based out of our office in Bangalore, India. Responsibilities Support the Quality Systems Manager in the management of AliveCor’s QMS Maintain AliveCor’s electronic document control database to ensure the efficiency of AliveCor document control process and compliance to AliveCor and regulatory standards Manage creation, revision, and obsolescence of SOPs, Work Instructions (WRKs), and forms in accordance with document control procedures and assist AliveCor team members with processing of urgent documents, reminders, and status updates, as needed Assist in compiling and organizing design inputs, risk management files, verification/validation reports, and other technical documentation. Support new product development teams in maintaining robust design controls by verifying that Design History Files (DHFs) accurately reference the current document numbers, revisions and associated Quality Records. Manage training records and assignments for quality-controlled procedures, including coordinating document revisions, running overdue training reports, sending overdue reminders, administering quizzes, facilitating password resets, and maintaining records per retention policies . Assist CAPA and NC owners with ensuring completeness of records. Prepare monthly meeting metrics, maintain logs, and send reminders for required activities (i.e. due dates and effectiveness checks) Manage and maintain the Approved Supplier List (ASL), ensure documentation is up-to-date for all suppliers, and coordinate activities related to supplier qualification, periodic re-evaluation, and audits in accordance with the Supplier Control procedures. Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records Support internal, supplier, and regulatory audits by ensuring documentation readiness, process adherence, compiling required deliverables, and tracking post-audit findings through to timely corrective action and closure. Maintain comprehensive calibration logs, coordinate timely calibration activities with internal teams or external metrology vendors, ensure accurate documentation of all measuring and monitoring equipment, and proactively verify compliance with established calibration schedules and quality standards. Support the integration of new requirements into the Quality Management System and applicable procedures to ensure ongoing compliance. Coordinate, manage, and lead programs related to quality improvement or business objectives as assigned by Quality System Manager and assist other functional areas, as needed Requirements Bachelor’s degree in Science or Engineering 5+ years of document control, QMS management, supplier management, and/or training administration function in the medical device or other regulated industry Working knowledge of FDA QSR (21 CFR 820), ISO 13485, EUMDR and applicable standards (ISO 14971, IEC 62366, etc.). Prior experience with electronic document management systems and/or learning management systems (LMS). Experience with Master Control is a plus Knowledgeable of Good Documentation Practices to perform and execute job responsibilities with a high level of accuracy Demonstrated ability to communicate effectively with internal and external customers and develop expertise to provide improved assistance Have good communication skills, both written and verbal. Strong editorial and technical writing skills a plus Excellent organisational skills along with strong attention to detail Ability to work both independently and collaboratively with small, cross-functional teams Highly proficient with Microsoft Office Suite and Adobe Acrobat Perks And Benefits We 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. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team

Description 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 Collaborate and execute regulatory strategies for US, Europe and other global registrations Participate in preparation and review of global regulatory submissions Support government/FDA interactions pertaining to medical device registrations and licensing; Participate in the development of regional regulatory strategy and update strategy based upon regulatory changes; Assist in the review of advertising and promotional materials; Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle; Support or lead regulatory activities required for US FDA, EU MDR, NMPA, PMDA, ANVISA compliance; Support worldwide resellers and distributors with product registrations and renewals; Provide regulatory assessment for manufacturing and design changes; Provide regulatory review and approval of change order packets; Support or lead product regulatory intelligence and risk assessments; Assist in maintaining compliance with product post market requirements; Support post-market regulatory actions taken for the products; Support internal and external audits; Ensure compliance with internal procedures and external regulations and standards; Maintain regulatory and quality records and other controlled documents; and Promote a culture of quality throughout AliveCor Requirements Bachelors degree in Science, Engineering, Math, or medical field or equivalent educational experience pertaining to technical writing, scientific method, and problem solving 4+ years of experience in medical device Regulatory Affairs Experience in regulatory affairs for software devices with AI/machine learning algorithms (SaMD) Participated in the preparation of pre-submissions, 510(k)s or de novo submissions Experience with and knowledge of EU Medical Device Regulations Ability to manage small projects: organised, independent, and results-oriented Superb analytical and excellent communication skills, strong team ethic, and attention to detail Preferred Candidate Profile Advanced degree or Regulatory Affairs Certification from RAPS Process-oriented thinking Supported or lead international submissions (preferably in Asia-Pacific and/or LATAM) Demonstrated competence documenting technical information and communicating it to others Perks And Benefits We 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. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits Above market family floater medical insurance coverage including both parents or in law parents Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team 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.

AliveCor is looking for a Software Engineer iOS to join their mobile application team and play a pivotal role in developing cutting-edge mobile applications that revolutionize the healthcare industry and redefine how consumers interact with their health data. As a Software Engineer iOS at AliveCor, you will collaborate closely with various teams including AI, security, backend, hardware, and product teams to deliver essential software solutions. You will work in an agile environment, providing quality estimates, designs, and implementations while problem-solving for complex global business requirements. You will be responsible for all aspects of modern software development, identifying problems proactively, and contributing as a team player in presenting solutions. Your role will also involve mentoring and grooming junior developers within the team. The ideal candidate should possess a B.E in Computer Science or a related field, along with 2-5 years of iOS programming experience, having successfully launched multiple apps on the App Store. Deep expertise in Swift is essential, while knowledge of Objective-C and Swift UI would be advantageous. Moreover, experience with iOS frameworks such as Core Data, Core Animation, and Core Bluetooth, as well as familiarity with RESTful APIs and modern programming principles, design patterns, and development tools is required. Knowledge of build process automation and CI/CD using GitHub/Gitlab will be beneficial. Excellent communication skills, a commitment to delivering results, a passion for continuous improvement, and the ability to thrive in a fast-paced environment are essential qualities for this role. AliveCor offers a range of perks and benefits to make your work-life balance seamless, including a hybrid working model, flexible vacation policy, maternity/paternity leave, generous medical benefits, and a supportive and collaborative team environment. By joining AliveCor, you will be part of a team that envisions a healthier world powered by personalized intelligent information and aims to be the world's heart health partner by providing quality heart care to all. AliveCor's innovative medical-grade hardware and software have already made a significant impact, with millions of users benefiting from our products. If you are passionate about building meaningful solutions and contributing to saving lives, AliveCor is the place for you. Join us in our mission to make a difference!,