AliveCor

Senior Regulatory Affairs Specialist

Clinical Trials Sales Director, BioPharma

Clinical Project Manager

Sales Support Specialist, Global Markets

Field Market Access Manager

Lead Software Engineer - Backend

Global Business Development Director

Principal Architect

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.

Rockstar Jobs

EA Jobs

Playstation Jobs

Ubisoft Jobs

Epic Game Jobs

Riot Jobs

CDPR Jobs

Krafton Jobs

Twitch Jobs

Larian Jobs

Wargaming Jobs

Naughty Dog Jobs

Netflix Jobs

Supercell Jobs

Zynga Jobs

Test your Unity Animations knowledge with this quiz! Explore concepts like Animator Controller, Blend Trees, and many more.

Test your Unity UI knowledge with this quiz! Explore essential concepts like Canvas, EventSystem and many more. 

Challenge yourself with this Unity Input System quiz! Test your skills in input mapping, device handling, and action events.

Take your Unity skills to the next level with Part 3 of this quiz, covering scripting, physics, rendering, and performance optimization!

Test your Unity expertise with this quiz, covering initialization to advanced rendering and physics!

Test your Unity knowledge with this comprehensive quiz, covering everything from MonoBehaviour basics to advanced physics, rendering, and optimization techniques across multiple difficulty levels!

Assess your knowledge of Unity's Rigidbody component and its advanced physics interactions with this in-depth quiz!

Test your understanding of Unity’s Physics, Movement, and MonoBehaviour with this insightful beginner-friendly quiz!

Dive into the fundamentals of open-world game development in Unity with this beginner-friendly quiz.

Challenge yourself with this beginner-friendly quiz on building an endless runner in Unity!

Test your beginner-level knowledge of Unity platformer development with this engaging quiz.

Test your basic knowledge of Unity and Unreal Engine with this beginner-friendly quiz on game development fundamentals.

This assessment evaluates your understanding of Unity's component-based architecture, how GameObjects and their components interact, the hierarchy system with nested GameObjects, and how to reference them in scripts.

This assessment evaluates your understanding of Unity's NavMesh system, including navigation baking, NavMeshAgents, pathfinding, obstacles, and scripting interactions with NavMesh to create AI-driven movement.

An assessment to test the correct usage of Unity's events and lifecycle functions in the context of the game "Clash Royale"

- This assessment gives us an idea of your C++ skills - Companies that evaluate this skillset in interviews: Rockstar Games, Ubisoft, Mayhem Studios, etc. - 10 Multiple Choice questions - Average time to complete: 7 to 10 minutes

Let's assess your Data Structures! 📋 &nbsp;- This assessment gives us an idea of your problem solving skills using DSA - Companies that evaluate this skillset in interviews: MPL, LILA Games, GSN Games, etc. - 10 Multiple Choice questions - Average time to complete: 7 to 10 minutes

Let's assess your Programming Patterns! 📋- This assessment gives us an idea of your code architecture skills - Companies that evaluate this skillset in interviews: Dirtcube, PTW, Playshifu, etc. - 10 Multiple Choice questions - Average time to complete: 7 to 10 minutes

Let's assess your OOPs skills! 📋- This assessment gives us an idea of your fundamental OOPS concepts and Solid principles skills - Companies that evaluate this skillset in interviews: Hitwicket, GSN Games, Tomo Club, etc. - 10 Multiple Choice questions - Average time to complete: 7 to 10 minutes

Let's assess your Unity Skills 📋 - This assessment gives us an idea of your Unity fundamentals - Companies you can apply for after taking this assessment: Godspeed games, Salvation Games, nCore Games, etc. - 9 questions: 9 Multiple Choice - Minimum score needed to qualify: 80% - Average time to complete: 5 to 10 minutes

Resolver

Generalist Analyst (Urdu Speaker)

Solution Consultant

Rush street interactive 

VIP Host

Room 8 Group

Realistic 3D Characters Grooming Team Lead

ghost story games

Senior Technical Producer

LILA Sciences

Vice President of Life Sciences Experimentation

Managed Services Analyst I

Operations Business Analyst

Fox Factory

Garage Technician 3

This Generalist Analyst role at Resolver focuses on identifying and mitigating online threats across critical Trust & Safety areas such as Violent Extremism, Graphic Violence, Child Endangerment, and Suicide and Self-harm. The successful candidate will leverage research, intelligence, and analytical skills to contribute to a safer internet for everyone. Working within a diverse, multinational intelligence team, the role requires a proactive commitment to researching new trends and risks, excellent communication, and fluent proficiency in both English and Urdu.

Product Manager

Customer Marketing Manager

Talent Acquistion Specialist

Specialist Analyst - 12 month FTC (Kurdish Speaker)

Account Executive

Director, Product Marketing

<h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Description</h3>Position at ResolverWould you like a role that makes a real world impact? The protection of children and vulnerable users has been a fundamental part of Resolver (formerly Crisp's) mission since the company was formed; we are now looking for a talented and committed individual to join our Intelligence team. It is only in diversity that we can tackle global problems; our analysts come from a wide range of nationalities and together we speak over 50 languages.In this role you will be identifying online threats across the Trust & Safety areas of Violent Extremism, Graphic Violence, Child Endangerment and Suicide and Self harm and is ideal for anyone wanting to use research, intelligence and analysis to make the internet a safer place for everyone.<h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">REQUIREMENTS</h3><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">A genuine interest in online safety meaning you are committed to proactively researching new trends and areas of risk.</li><li class="leading-relaxed">A keen problem solver who is highly inquisitive in nature.</li><li class="leading-relaxed">Excellent communication skills, particularly the ability to write concise and informative reports.</li><li class="leading-relaxed">Ability to work and communicate with teams from around the world, writing up handover notes and meeting outcomes.</li><li class="leading-relaxed">A demonstrable interest in intelligence and intelligence analysis.</li></ul><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">ESSENTIAL EXPERIENCE</h3><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Fluent proficiency in English and Urdu (this includes the ability to read and write as well as speak fluently).</li><li class="leading-relaxed">Existing knowledge and ability to carry out research across different social media platforms.</li><li class="leading-relaxed">Excellent research and report-writing skills, critical thinking, and attention to detail.</li><li class="leading-relaxed">Ability to prioritise, manage deadlines and workloads across multiple issues/cases.</li><li class="leading-relaxed">Creativity and flexibility in addressing specific case or project needs and changes of circumstance.</li></ul>BENEFITSWe believe in hard work and having fun while we work. We invest in our people, and we think big.Team: we have smart, talented and curious people you'll work with and learn from. As a Product company, you'll be hands-on with our global teams and top-tier leadership in the UK, US, Mexico and the Philippines.Professional development: we have an external learning budget to help you grow and develop. We also have great online learning and workshops internally for you to tap in to.Impact: we solve complex challenges for some of the world's most recognized organizations. Our customers use our software to help reduce the frequency and severity of negative events to protect people, product and organizational success. What we do matters.Vacation: It’s important for you to have time off to re-charge your battery and be with your family and friends. Paid time and sick/casual accrual are 15 days and 12 days per year respectively.Parental leave: we support new Mothers with 100% top-up Maternity leave is up to 26 weeks and new Fathers receive 10 days of Welcome Leave.Great benefits: 100% paid by us for health, accident and life, medical privileges include dental and outpatient too. We also offer a wellness/fitness reimbursement, that can go towards things like gym memberships, yoga classes, soccer membership fees or a cycle.Office perks: our environment is flexible, with great snacks and chai. We love our newly renovated office and table tennis. We do socials and events for people to come together.Learning: we invest in the development of our people through online learning, group learning and external learning.Wellness/fitness reimbursement: we care about your health<h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">STATEMENT:</h3>'This work meets the requirements in respect of exempted questions under the Rehabilitation of Offenders Act 1974, any applicants who are offered work for this organisation will be subject to an enhanced check from the Disclosure and Barring Service (DBS). This will include details of cautions, reprimands or final warnings as well as convictions. A criminal record will not automatically bar a person from successfully taking up this post.Resolver, a Kroll business, is committed to creating an inclusive work environment. We are proud to be an equal opportunity employer and will consider all qualified applicants regardless of gender, gender identity, race, religion, colour, nationality, ethnic origin, sexual orientation, marital status, veteran status, age or disability.

Follow Mayank - career advice

Follow Mayank Grover for game development resources

Free | C# | Midnight Pizza Fight

Free | C++ | Lethos

Free | C++ | Pong

Follow Abhishek - tech content

Follow Abhishek Smith for game programming content

This assessment gives us an idea of your C++ skills- Companies that evaluate this skillset in interviews: Rockstar Games, Ubisoft, Mayhem Studios, etc.- 10 Multiple Choice questions- Average time to complete: 7 to 10 minutes

Let's assess your Data Structures! - This assessment gives us an idea of your problem solving skills using DSA- Companies that evaluate this skillset in interviews: MPL, LILA Games, GSN Games, etc.- 10 Multiple Choice questions

Data Structures and Algorithms

Let's assess your Programming Patterns! ????- This assessment gives us an idea of your code architecture skills- Companies that evaluate this skillset in interviews: Dirtcube, PTW, Playshifu, etc.

Programming Patterns

Let's assess your OOPs skills! ????- This assessment gives us an idea of your fundamental OOPS concepts and Solid principles skills- Companies that evaluate this skillset in interviews: Hitwicket, GSN Games, Tomo Club, etc.

Object Oriented Programming

Let's assess your Unity Skills ????- This assessment gives us an idea of your Unity fundamentals- Companies you can apply for after taking this assessment: Godspeed games, Salvation Games, nCore Games, etc.