Regulatory Expert for Medical Device Development
il y a 1 jour
We are seeking a highly skilled Regulatory Expert to join our dynamic team at Robeauté. As a key contact with regulatory authorities, you will guide our medtech innovations through complex regulatory landscapes.
Key Responsibilities- Lead the design control process for verification and validation (V&V) and ensure compliance throughout the product development lifecycle.
- Implement and manage quality management systems (QMS) to support FDA and EMA regulations.
- Serve as the primary liaison with FDA and EMA for regulatory processes and manage audits as required.
- Supervise quality and regulatory operations at our manufacturing site.
- Experience in leading at least one full FDA cycle on a complex medtech product.
- Excellent verbal and written communication skills to collaborate with multidisciplinary teams.
- Able to balance regulatory and quality requirements with project size and maturity while ensuring compliance.
- Fast learner ready to dive into the role with a steep learning curve.
- Passion for contributing to Robeauté's mission and making an impact.
- Flexible remote work options.
- BSPCE stock options available.
- Salary based on experience: €80,000 - €120,000 per year.
-
Regulatory Affairs Specialist for Medical Devices in Paris
il y a 3 semaines
Paris, Île-de-France ProductLife Group Temps pleinIn the context of a new project, ProductLife Group is seeking a Regulatory Affairs Officer with expertise in medical devices to join our team in Paris.Job DescriptionWe are looking for a highly skilled professional to oversee the regulatory affairs process for our medical devices. As a key member of our team, you will be responsible for ensuring compliance...
-
Regulatory Expert for Biologics Development
il y a 4 semaines
Paris, Île-de-France VCLS Temps pleinJob SummaryWe are seeking an experienced Regulatory Scientist to join our team as Associate Director, Regulatory Science CMC. As a key member of our team, you will provide strategic guidance on CMC development pathways, regulatory submissions, and risk assessment.About the RoleThis is a pivotal opportunity for a highly skilled professional to contribute to...
-
Software Development Engineer for Medical Devices
il y a 1 semaine
Paris, Île-de-France EDUCAT Temps pleinAs a Software Development Engineer for Medical Devices at EDUCAT, you will have the opportunity to contribute to the development of innovative medical devices that transform healthcare and improve patient outcomes.About the RoleThis full-time position requires relocation to Paris, France, where you will be part of our dynamic and innovative R&D team. Your...
-
Medical Regulatory Expert for Complex Medtech Products
il y a 1 jour
Paris, Île-de-France Cherry Ventures Temps pleinOverviewAt Cherry Ventures, we are seeking an experienced Medical Regulatory Expert to lead the development and implementation of regulatory strategies for our complex medtech products. This is a unique opportunity for a seasoned professional to leverage their expertise in FDA regulations and contribute to the growth and success of our company.
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, Île-de-France DentalMonitoring Temps pleinJob Description:DentalMonitoring is a MedTech scale-up in the rapidly growing medical field. We are looking for talented professionals to join our team.Company OverviewWe are pioneers in using AI-driven technology in oral healthcare, with more than filed patents and a leading position in the industry. Our solutions monitor and optimize orthodontic treatment...
-
Quality Assurance Manager for Medical Device Development
il y a 1 semaine
Paris, Île-de-France Eko Devices Temps pleinWe are Eko Devices, a remote-first organization with over 40 full-time engineers working from diverse locations. Our headquarters and hardware development team are in Stockholm, Sweden.Our company is committed to ensuring the highest quality of our products and services across various domains.We are seeking an experienced Quality Assurance Manager to join...
-
Senior Medical Device Electronics Specialist
il y a 1 semaine
Paris, Île-de-France EDUCAT Temps pleinAbout EDUCAT">EDUCAT is a dynamic start-up based in Paris that aims to revolutionize healthcare solutions. Our mission is to develop cutting-edge medical devices that improve patient outcomes and transform the lives of people around the world.">About the Role">We are seeking an experienced Senior Medical Device Electronics Specialist to lead our electronic...
-
Senior Software Development Engineer
il y a 1 mois
Paris, Île-de-France EDUCAT Temps pleinAs a highly skilled Software Development Engineer, you will be part of our R&D team at EDUCAT, responsible for designing and developing innovative software solutions for our active implantable medical devices.About the RoleKey Responsibilities:Conduct feasibility studies and design software tools to inform the design and development processCollaborate with...
-
Electronic Devices Development Engineer
il y a 2 semaines
Paris, Île-de-France Brightflow Temps pleinElectronics Development Engineer OpportunityBrightflow, a pioneering medical device company, seeks a highly skilled Electronics Development Engineer to join its Research and Development team in Paris, France.The ideal candidate will be responsible for driving the design, development, and testing of our innovative implantable assist device. With a strong...
-
Senior Biologics Development Lead
il y a 1 semaine
Paris, Île-de-France VCLS Temps pleinVCLS is seeking a highly experienced Senior Biologics Development Lead to oversee the development of biologics products. As a key member of our team, you will be responsible for guiding clients through the complex regulatory landscape of CMC development and ensuring compliance with EU and US regulations.The ideal candidate will have at least 5 years of...
-
Senior Compliance Officer EU
il y a 4 semaines
Paris, Île-de-France Relai AG Temps pleinJob OverviewWe are seeking a highly skilled Senior Compliance Officer EU to join our team at Relai AG. As a key member of our compliance department, you will be responsible for ensuring our company's regulatory compliance in the European Union.Key ResponsibilitiesRegulatory Compliance Management: Lead efforts to obtain and maintain necessary licenses under...
-
Expert Medical Specialist for Tertiary Care
il y a 1 semaine
Paris, Île-de-France Medical Specialist Group Temps pleinAbout the Medical Specialist Group We are a partnership of currently 55 Consultants, which under contract provides specialist medical services to the Guernsey Health Service with a unique healthcare model separate from the NHS.Role OverviewAs an Expert Medical Specialist for Tertiary Care, you will provide high-level medical expertise in gastroenterology,...
-
Regulatory Expert Lead
il y a 1 semaine
Paris, Île-de-France Veeva Systems, Inc. Temps pleinVeeva Systems, Inc. is a leading provider of cloud-based software solutions for the life sciences industry.We are seeking an experienced Regulatory Expert to join our team as a Director Strategy in Veeva’s Regulatory Information Management market share. As a key member of our team, you will drive growth and strategy, working with industry experts to...
-
Regulatory Growth Expert
il y a 1 semaine
Paris, Île-de-France Veeva Systems, Inc. Temps pleinAbout Veeva Systems, Inc.We're a pioneering public benefit corporation (PBC) that balances the interests of customers, employees, society, and investors. Our unique approach has made us a leader in the industry.SalaryThe estimated salary for this role is $120,000 - $180,000 per year, depending on experience.Job DescriptionThis senior position will focus on...
-
Compliance Director for EU Regulatory Engagement
il y a 1 semaine
Paris, Île-de-France Moody's Investors Service Temps pleinAt Moody's Investors Service, we are seeking an experienced Compliance Officer to join our EU Compliance advisory team.**Job Summary:**The Compliance Officer will work in an evolving regulatory environment and assist the Compliance Department in supporting regulatory engagement in EU. This role will involve leading on responses to regulatory requests,...
-
Regulatory Compliance Expert
il y a 2 semaines
Paris, Île-de-France Relai AG Temps pleinRelai AG is a Swiss-licensed, Bitcoin-focused financial service provider with over $500 million in trading volume. In 2024, Relai was named one of the fastest-growing startups in Europe by Sifted and listed among the top 10 Swiss startups.We are seeking an exceptional Regulatory Compliance Expert to join our team. As a key member of our compliance team, you...
-
Senior Manager of Regulatory Affairs and Program Development
il y a 1 semaine
Paris, Île-de-France Sobi group Temps pleinWe are seeking a Senior Manager of Regulatory Affairs and Program Development to join our team at the Sobi group.About UsAt Sobi, we are dedicated to taking on the world's diseases, ailments, and adversity. Our deeply skilled management team directs our day-to-day wins, and our Board has a stellar track record. We offer a competitive benefits package to...
-
Lead Mechanical Engineer for Next Generation Wearable Devices
il y a 4 semaines
Paris, Île-de-France Snap Inc. Temps pleinAbout Snap Inc.Snap Inc. is a technology company pushing the boundaries of what a camera can be, specifically overlaying computing on the real world.Estimated Salary:$140,000 - $180,000 per yearJob Description:We are looking for a Lead Mechanical Engineer to help us shape the future of neural interface technology in our Next Generation wearable devices.Key...
-
Regulatory Expert in CMC Document Preparation
il y a 1 semaine
Paris, Île-de-France RBW Consulting Temps pleinSenior CMC Regulatory Technical WriterThis is an exciting opportunity to contribute to the development of groundbreaking therapies by ensuring the highest quality in regulatory submissions.About the Role:We are seeking a detail-oriented technical writer with a passion for regulatory science to join our dynamic CMC Regulatory Department as a Senior CMC...
-
Senior Electronics Development Lead
il y a 2 semaines
Paris, Île-de-France Brightflow Temps pleinElectronics Engineer - Job OverviewBrightflow, a cutting-edge medical device start-up, is revolutionizing the cardiac assist device market. Our goal is to create a novel, long-term implantable device. Founded in 2019, we've secured significant seed funding and are seeking an experienced Electronics Engineer to join our R&D team.Job ResponsibilitiesUnder the...