IVDR Regulatory Compliance Manager
7 hours ago
A career in Regulatory Affairs at Agilent Technologies offers the opportunity to work on innovative solutions and expertise.
Our company enables customers to improve the world around them. We provide instruments, services, consumables, applications, and expertise that support research and diagnostics in various fields.
Job Description:
We are looking for a Regulatory Affairs Specialist to coordinate international submissions, product change notifications, and licensing requirements for our IVD products. This role involves implementing regulatory compliance strategies, collaborating with Global Regulatory Affairs, and working with project teams to deliver project milestones.
Key Qualifications:
- Relevant university degree in Life Science, Engineering, or Law
- Significant regulatory experience with a deep understanding of IVD/medical device regulations
- Ability to communicate effectively in English
Why Choose Agilent?
We offer a range of benefits, including employee benefits, result bonus, and stock purchase plan. Our company values independence, work/life balance, and collaboration. We also offer opportunities for professional growth and development.
-
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeAbout the RoleAgilent Technologies is seeking a highly skilled Project Manager to lead the transition of our existing In Vitro Diagnostic (IVD) pathology portfolio to compliance with the European Regulation on In Vitro Diagnostic Medical Devices (IVDR). As a key member of our IVDR Program Office, you will be responsible for driving this critical initiative...
-
Supply Chain Manager to Medical Device Logistics
18 hours ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeAbout Agilent Technologies\We are a global leader in life sciences, diagnostics, and applied chemical markets. Our goal is to advance the quality of life by inspiring and supporting discoveries.\We strive to ensure the safe delivery of products worldwide, adhering to quality and compliance standards such as ISO 13485, IVD, IVDR, and MDSAP certifications.\In...
-
Supplier Compliance Engineer
18 hours ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeAbout the RoleAs a Senior Supplier Quality Engineer at Agilent Technologies, you will play a critical role in ensuring the quality of our suppliers and their products. Your responsibilities will include leading projects to improve supplier quality processes, compiling key quality agreements, owning supplier quality processes, and running supplier monitoring...
-
Senior Quality Assurance Specialist
3 days ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeCompany Overview:Agilent Technologies is a leading provider of life science, diagnostic, and applied market laboratories with instruments, services, consumables, applications, and expertise. We enable our customers to gain the answers and insights they seek so they can improve the world around us.Job Description:The Senior Supplier Quality Engineer will play...
-
R&D Hardware Innovation Specialist
18 hours ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeJob DescriptionWe are seeking a R&D engineer to join our System Lifecycle Support team, which is part of Pathology R&D in our Diagnostics and Genomics Group.The team's responsibilities include:Instrument improvements projects/activities, such as feature enhancements and design optimizations based on customer feedback;Instrument product care/sustaining...
-
Senior Medical Device Development Engineer
3 days ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeJob Overview\We are seeking an experienced R&D Hardware Engineer to join our team in System Lifecycle Support. This role is part of Pathology R&D in our Diagnostics and Genomics Group, aiming to strengthen our System Lifecycle engineering activities.\The successful candidate will contribute to the development and maintenance of high-quality portfolio of...
-
Transition Manager
18 hours ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeAbout the RoleWe are looking for a motivated individual who is open-minded, proactive, eager to learn, and does not mind challenging the 'norm'. You are curious and enjoy solving problems. You also have great interpersonal skills to communicate internally and externally, working with a diverse group of stakeholders.Main Responsibilities:Develop and execute...
-
Curriculum Development Specialist
3 days ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeCompany Overview">At Agilent Technologies, we empower scientists and researchers to advance the quality of life. Our mission is to provide innovative solutions that drive breakthroughs in various fields, including life sciences, diagnostics, and applied markets.">About the Job">We are seeking a dynamic individual to join our team as a Curriculum Manager. In...
-
Field Quality Assurance Specialist
3 days ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeJob OverviewWe are seeking a skilled Field Quality Assurance Specialist to join our team at Agilent Technologies. In this role, you will be responsible for managing field action activities, leading strategy and communication meetings, recalls, and correction processes for medical and non-medical products.Main ResponsibilitiesAction Strategy Development:...
-
Electrical Ground Support Equipment Specialist
18 hours ago
Glostrup, Glostrup Kommune, Denmark Rovsing AS Full timeJob Title: Electrical Ground Support Equipment SpecialistRovsing A/S, a renowned provider of cutting-edge technology, is seeking an experienced Electrical Ground Support Equipment Specialist to join their EGSE project team.About the Role:As an Electrical Ground Support Equipment Specialist, you will play a critical role in designing and developing Electrical...
-
Software Technical Solution Designer
18 hours ago
Glostrup, Glostrup Kommune, Denmark Rovsing AS Full timeJob Title: Software Technical Solution DesignerRovsing A/S, a leading provider of technical solutions, is seeking a dedicated and committed software technical solution designer to join their EGSE project group.About the Role:As a software technical solution designer, you will be responsible for defining the overall technical architecture, requiring a...
-
Logistics Manager for Continuous Improvement
3 days ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeOverviewAgilent Technologies is a global leader in life sciences, diagnostics, and applied markets. We inspire discoveries that advance the quality of life by providing innovative solutions to customers worldwide.We are committed to quality and compliance with international standards, ensuring the safe delivery of products globally. Our focus on...
-
Manufacturing Validation Expert
7 hours ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies, Inc. Full timeRole OverviewYou will play a pivotal role in ensuring the quality of Agilent's production of reagents for cancer diagnostics, thereby improving patients' quality of life.This involves leading all aspects of validation activities at the Glostrup manufacturing site. Collaborating with cross-functional teams is essential to ensure equipment, cleaning, and...
-
EMEA Marketing Campaign Strategist
3 days ago
Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full timeMarketing Communications Specialist Job DescriptionAt Agilent Technologies, we foster a culture of innovation and discovery. Our mission is to provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. We enable our customers to gain the answers and insights they seek –...
-
Regulatory Affairs Specialist, IVDR
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeRegulatory Affairs Specialist, IVDR Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do...
-
Compliance Operation Lead
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Are you experienced with regulatory requirements for medical devices? At Agilent, we develop and produce reagents, instruments, and software for in vitro diagnostic of cancer, and we are currently looking for a Compliance Operation Lead to work primarily in Corrective and Preventive Action as well as in Inspection Readiness projects but also...
-
Project Manager
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the...
-
Supplier Quality Engineer
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the...
-
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the...
-
Glostrup, Denmark Eurofins GSC Poland Sp. z o. o. Full timeBusiness Unit Manager Biopharma Process Control Danemark49_744000028345355Obowiązki We are seeking a candidate motivated by acquiring and sharing technical knowledge and driven to expand and strengthen our business area within process control.Our Process Control & Validation department offers consulting services in hygiene monitoring, cleanroom...
-
Glostrup Kommune, Denmark Eurofins Humangenetik & Pränatal-Medizin Full timeBusiness Unit Manager Biopharma Process Control Danemark Full-time Eurofins BioPharma Product Testing Denmark A/S is a world-leading global contract laboratory in the pharmaceutical field. We provide the pharma and medical device industries with microbiological and chemical analyses, process control, and laboratory services in compliance with GMP. Are you...
-
Territory Sales Manager
4 days ago
Glostrup Kommune, Denmark CONMED Corporation Full timeJob Title: Territory Manager (Orthopaedics) - Denmark Reporting to: Nordic Sales Manager - Orthopaedics Business Function: Orthopaedics – Nordic Region Territory: Region Hovedstaden, Sjaelland + Fyn Company Overview CONMED is a global leader in medical technology, dedicated to developing and delivering surgical and patient monitoring products that...
-
Team Leader
4 days ago
Glostrup Kommune, Denmark Eurofins Humangenetik & Pränatal-Medizin Full timeEurofins BioPharma Product Testing Denmark A/S is a world-leading global contract laboratory in the pharmaceutical field, providing the pharmaceutical industry with microbiological and chemical analyses, process control, and consulting services for laboratory services according to GMP. The microbiological laboratory in Glostrup performs microbiological...
-
Field Action Specialist
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeField Action Specialist Job Description The Global Quality and Regulatory Affairs (GQRA) Field Action Specialist’s responsibilities include managing Field Action Activities such as leading Field Action Strategy and Field Safety Communication meetings, recalls, field notifications, and correction processes for medical and non-medical products. Duties...
-
R&D Hardware Engineer
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description We are seeking a R&D Engineer for our System Lifecycle Support team which is part of Pathology R&D in our Diagnostics and Genomics Group. We want to strengthen our System Lifecycle engineering activities to ensure efficient and successful progress in new sustaining projects and maintenance of our high-quality portfolio of pathology stainer...
-
Associate Global Product Manager
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the...
-
Global Product Manager, Pathology
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the...
-
Content Designer
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Eager to take your next step in your career as a Graphic Designer? This is your opportunity to join a dynamic and versatile team of 17 creative professionals in Agilent’s Creative Center of Excellence (CCoE). We are looking for an experienced Content Designer to create engaging and on-brand graphics for a variety of channels. As a key...
-
Curriculum Manager
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the...
-
Curriculum Manager
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the...
-
Glostrup, Denmark House of Control Denmark AS Full timeEr du er typen, der hader at tabe i LUDO? Så er du kommet til det rette sted. For vi er lige så dårlige tabere, som du er. Til gengæld er vi også rigtig gode til at få de gode aftaler i hus. Og fejre sejrene sammen. Hos os får du: - gode karrieremuligheder i succesfuldt softwarehus - de bedste kolleger med et kanon sammenhold - chancen for at...
-
Software/Hardware Design Control Specialist
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeJob Description Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek, so they can do what they do best: improve the world...
-
EMEA Marketing Communications Specialist
4 days ago
Glostrup Kommune, Denmark Agilent Technologies Full timeEMEA Marketing Communications Specialist Job Description Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so...
-
System Engineer
4 days ago
Glostrup Kommune, Denmark Rovsing AS Full timeRovsing A/S Glostrup Municipality, Capital Region of Denmark, Denmark Would you like to work in an international , dynamic , and challenging environment? Would you like to work in the space industry ? Then Rovsing A/S could be the right challenge for you! Due to increased activity in our EGSE project group, we are looking for a dedicated and committed...