Complear
Regulatory Affairs / Quality Assurance Consultant (Senior)
Complear, Baltimore, Maryland, United States,
Regulatory Affairs / Quality Affairs Consultant (Senior)The Company
The mission of Complear is to build the digital platform that becomes the operating system of Digital Health products compliance with Medical Device Regulations around the world.We want to make it easy for Digital Health teams of any background to become compliant from day 1, while driving business strategy decisions supported by solid regulatory information. Our goal is to empower teams using automation and community intelligence on most of the process of building and running a quality system for Digital Health products, allowing companies to quickly set up and scale their operations, enter the market, while navigating the continuous flexibility of software.The Job
As a Senior Regulatory Affairs and/or Quality Affairs Consultant, you will work closely with our Head of Regulatory to support medical device (MD), in-vitro diagnostic medical devices (IVD) with a focus on software as medical device (SaMD), including AI as a medical device (AIaMD), companies to bring their products to market, by achieving CE Mark in EU and/or similar approval in other countries.We are looking for people that have experience in the field either as Consultants, or RA/QA in Medical Device Software Companies, but still eager learners, and seek all sorts of information to have the best opinion on strategic decisions.If you believe that working with clients to manage successful projects, making a product clear to everyone, writing detailed documentation about it, keeping track of all the small details in an engineering project, imagining how to make an architecture of software compliant, and spending some time discussing some legal wording interpretation would make your day, then this job is for you.You will support the implementation of Medical Device Regulation (MDR), In-Vitro Medical Device Regulation (IVDR), FDA (US) and corresponding standards, such as ISO 13485 (Quality Management System), ISO 27001 (Information Security), among others.You will work with the most innovative companies and startups across Europe and US in the field of Digital Health, getting to understand their product, business and processes, to support their endeavours of navigating the Medical Device and In-Vitro Medical Device Regulations across the world.You will continuously learn by doing, working hands-on in projects, with access to the best expertise in the field and with the support of our team of experts you will be exploring novel approaches and become yourself an expert in the field. At the same time, you will have a unique opportunity to contribute to the launch of a new Digital Product that will change how companies navigate the regulatory requirements of medical devices.Complear is based in Portugal, but we work fully remote, so you can live anywhere in the world.EXPECTATIONS
Your job is as follows:Learn every day:
We don’t expect to know everything, we only expect you to be eager to learn and gain experience in the regulation of medical devices to ensure safety and efficiency. You won’t be alone on this challenge! You can rely on our team and network of experts to be there for you.Hands-on responsibility:
As a member of the regulatory affairs team, you support the regulatory strategy and documentation, so attention to detail is fundamental, but efficiency to turn the best work on the time we can commit to is essential.Organize the World:
You will thrive while compiling and systematizing technical and clinical information from different sources (meetings, documentation, research, etc.). You will be a critic and use strategic thinking on what is made, and be able to pay attention to the smallest details. You will be able to navigate and communicate with people from cross-functional teams to address questions related to regulations and quality, making sure everyone gets the best understanding of the concepts and decisions.Focus on delivering to Clients’ needs:
You will be focused on delivering what the client needs to do their job best. This means you need to understand their needs, empathizing with what they seek, and deliver at the speed that is needed.Be part of an exciting team:
We are a startup working in the amazing and boiling environment of medical devices both as consultants and building a new software to change how things are done. This is the future, and our team already makes part of it. Come join us!THE ABSOLUTE UNICORN CANDIDATE
This is a great position for someone who wants to gain experience in regulatory affairs of medical devices focused on Digital Health, and not be afraid of exploring new approaches to traditional consultancy.We are looking for someone with:A Graduate degree in a relevant educational engineering field (e.g. Biomedical Engineering, Engineering or similar subjects)Good communication skills, quick learner and computer savvyEnglish Language Proficiency (Portuguese is desirable but not required)Familiar knowledge of EU and/or FDA medical device regulationsFamiliar with the concepts of Medical Device Regulation, ISO 13485 and FDA QSR and IEC 62304 requirements within a Quality Management SystemExperience in the preparation of Technical Documentation for Medical Devices, in particular, Medical Device SoftwareCommunicative team player, able to work in a precise and goal-oriented manner with the capability of independent and networked thinkingComfortable in managing projects with client teams and leading multiple stakeholders to successFeel comfortable not reinventing the wheel as long it delivers something more efficientlyAn ability to keep things organised, prioritise, and be responsible for setting and meeting deadlines in a remote teamHow to Apply
The best candidate is so good that they want to build something big, but humble enough to realize that the best opportunities still require
some
hustle.Please send us an email to jobs@complear.com that explains who you are, why you could be a fit, and what your priorities are for what you do next.
#J-18808-Ljbffr
The mission of Complear is to build the digital platform that becomes the operating system of Digital Health products compliance with Medical Device Regulations around the world.We want to make it easy for Digital Health teams of any background to become compliant from day 1, while driving business strategy decisions supported by solid regulatory information. Our goal is to empower teams using automation and community intelligence on most of the process of building and running a quality system for Digital Health products, allowing companies to quickly set up and scale their operations, enter the market, while navigating the continuous flexibility of software.The Job
As a Senior Regulatory Affairs and/or Quality Affairs Consultant, you will work closely with our Head of Regulatory to support medical device (MD), in-vitro diagnostic medical devices (IVD) with a focus on software as medical device (SaMD), including AI as a medical device (AIaMD), companies to bring their products to market, by achieving CE Mark in EU and/or similar approval in other countries.We are looking for people that have experience in the field either as Consultants, or RA/QA in Medical Device Software Companies, but still eager learners, and seek all sorts of information to have the best opinion on strategic decisions.If you believe that working with clients to manage successful projects, making a product clear to everyone, writing detailed documentation about it, keeping track of all the small details in an engineering project, imagining how to make an architecture of software compliant, and spending some time discussing some legal wording interpretation would make your day, then this job is for you.You will support the implementation of Medical Device Regulation (MDR), In-Vitro Medical Device Regulation (IVDR), FDA (US) and corresponding standards, such as ISO 13485 (Quality Management System), ISO 27001 (Information Security), among others.You will work with the most innovative companies and startups across Europe and US in the field of Digital Health, getting to understand their product, business and processes, to support their endeavours of navigating the Medical Device and In-Vitro Medical Device Regulations across the world.You will continuously learn by doing, working hands-on in projects, with access to the best expertise in the field and with the support of our team of experts you will be exploring novel approaches and become yourself an expert in the field. At the same time, you will have a unique opportunity to contribute to the launch of a new Digital Product that will change how companies navigate the regulatory requirements of medical devices.Complear is based in Portugal, but we work fully remote, so you can live anywhere in the world.EXPECTATIONS
Your job is as follows:Learn every day:
We don’t expect to know everything, we only expect you to be eager to learn and gain experience in the regulation of medical devices to ensure safety and efficiency. You won’t be alone on this challenge! You can rely on our team and network of experts to be there for you.Hands-on responsibility:
As a member of the regulatory affairs team, you support the regulatory strategy and documentation, so attention to detail is fundamental, but efficiency to turn the best work on the time we can commit to is essential.Organize the World:
You will thrive while compiling and systematizing technical and clinical information from different sources (meetings, documentation, research, etc.). You will be a critic and use strategic thinking on what is made, and be able to pay attention to the smallest details. You will be able to navigate and communicate with people from cross-functional teams to address questions related to regulations and quality, making sure everyone gets the best understanding of the concepts and decisions.Focus on delivering to Clients’ needs:
You will be focused on delivering what the client needs to do their job best. This means you need to understand their needs, empathizing with what they seek, and deliver at the speed that is needed.Be part of an exciting team:
We are a startup working in the amazing and boiling environment of medical devices both as consultants and building a new software to change how things are done. This is the future, and our team already makes part of it. Come join us!THE ABSOLUTE UNICORN CANDIDATE
This is a great position for someone who wants to gain experience in regulatory affairs of medical devices focused on Digital Health, and not be afraid of exploring new approaches to traditional consultancy.We are looking for someone with:A Graduate degree in a relevant educational engineering field (e.g. Biomedical Engineering, Engineering or similar subjects)Good communication skills, quick learner and computer savvyEnglish Language Proficiency (Portuguese is desirable but not required)Familiar knowledge of EU and/or FDA medical device regulationsFamiliar with the concepts of Medical Device Regulation, ISO 13485 and FDA QSR and IEC 62304 requirements within a Quality Management SystemExperience in the preparation of Technical Documentation for Medical Devices, in particular, Medical Device SoftwareCommunicative team player, able to work in a precise and goal-oriented manner with the capability of independent and networked thinkingComfortable in managing projects with client teams and leading multiple stakeholders to successFeel comfortable not reinventing the wheel as long it delivers something more efficientlyAn ability to keep things organised, prioritise, and be responsible for setting and meeting deadlines in a remote teamHow to Apply
The best candidate is so good that they want to build something big, but humble enough to realize that the best opportunities still require
some
hustle.Please send us an email to jobs@complear.com that explains who you are, why you could be a fit, and what your priorities are for what you do next.
#J-18808-Ljbffr