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Regulatory Affairs Clinical Specialist

Due to many activities in our exciting clinical development projects, we are seeking two new colleagues to our Regulatory Affairs function.

Your key responsibilities will be to contribute with regulatory expertise to global strategies and execution within your assigned project(s). You will be the regulatory responsible in the clinical trial teams and provide regulatory guidance and support for the planning, execution, and reporting of clinical trials worldwide.

Test & Reliability Engineer - Sustaining Engineering, Medical Devices

Do you have a keen eye for Physical Testing, Product Quality, Reliability, Validation, and Documentation? Are you looking for an opportunity to merge your passion with our expertise in the Test and Verification of Infusion Care Medical Devices, for the treatment of chronic diseases such as Diabetes and Parkinson’s Disease?

As a Test Engineer, you will be involved in developing and working with a diversity of physical test methods. Planning and coordinating tests in our laboratory in Osted near Roskilde, and partners within Global Convatec and external. Most of your time, you will be part of a project team in SEG.

Sustainability Advisor

Hvad har lufthavnen (en af Danmarks største virksomheder), en mellemstor dansk kommune og et stort parkeringshus til fælles?

De har alle et stort energiforbrug, og derfor arbejder vi i Københavns Lufthavne med at sætte en dagsorden for bæredygtighedsområdet. For eksempel har vi siden 2022 opsat over 400 el-ladestandere omkring lufthavnen, til at oplade både passagerers, partneres og egne el-køretøjer.

Vi er med til at udvikle nye teknologiske løsninger for luftfartsbranchen. Det bidrager til, at vi i 2030 når vores mål om at være net zero for vores egen drift, som omfatter vores energi- og brændstofforbrug. I 2050 udvides målet til at være net zero for hele vores drift og værdikæde.

Biocompatibility Specialist

We are looking for a Biocompatibility Specialist to join the Reprocessing and Biocompatibility team for a 12-month project position.

This is a great opportunity if you would like to gain experience with biocompatibility for advanced reusable medical devices, as you will be part of a cross-functional effort on documenting the safety and performance through the lifetime of our ultrasound scanners, transducers, and accessories.

Training Partner

Are you passionate about designing high impact training to improve ways of working?

The role will focus on re-designing the training related to onboarding our professionals working directly with our operation, our Operators, and our Laboratory Technicians.

You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words.

Regulatory Affairs Specialist

The RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

In this role, you will have the opportunity to:

• Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
• Ensure compliance with EU regulations.
• Generate STED files, international submissions & assess design changes.
• Plan and execute projects for new regulatory requirements.

Senior Regulatory Specialist

The Senior Regulatory Affairs Specialist at Radiometer is responsible for collecting and generating documentation for product submissions to ensure compliance with international regulations. This role is critical for ensuring that Radiometer's products can be sold in markets around the world.

If you thrive in a fast-paced environment, are used to playing a critical supporting role and want to work in a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.

Senior Test Engineer

Join GE HealthCare to help perform transducer integration on our next-generation ultrasound scanners and further develop our test tools and laboratories.

As our new Senior Test Engineer, your typical tasks will include measurements of sound pressure, acoustic power, thermal characteristics, image performance and other transducer properties.

You will take part in hands-on work while also playing a key role in maintaining and further developing our transducer integration processes and two laboratories.

Regulatory Affairs Manager

The Regulatory Affairs Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations.

This role is critical for ensuring that Radiometer's products can be sold in markets around the world. You will have the opportunity to:

• Ensure regulatory compliance to maintain market approvals
• Lead a team of skilled RA associates
• Ensure alignment with relevant stakeholders

Head of the Department of Virus & Microbiological Special Diagnostics

Do you have solid management experience and deep insight and experience within virology?

As Head of the Department of Virus & Microbiological Special Diagnostics, you are responsible for the daily management of the department to ensure the diagnostic preparedness for infection in a one-health perspective with synergy between laboratory diagnostics in humans and animals.

Senior Specialist Clinical Safety and Pharmacovigilance (CSPV)

At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system.

The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in Denmark and globally. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.

You would add your clinical safety and pharmacovigilance expertise as your depth knowledge of the PV legislation to the team.

External Lecturer – “Medical Biotechnology and Drug Development” – DIS Copenhagen

The teaching position is for the fall semester, which will begin in August. You will teach highly motivated undergraduate students from North American universities who are spending a semester studying in Copenhagen.

Why teach at DIS?

• Work in an international, informal and enthusiastic environment with an emphasis on cross-cultural understanding, teamwork, innovation, and adaptability
• Develop interactive and experiential teaching skills and teaching experience in English

Senior Application Specialist - Culinary

For the Culinary Design in Brabrand, we are seeking a Senior Application Specialist to assist us in servicing our external and internal customers.

Main Responsibilities:

• Servicing our European based customers within the Culinary solutions – from Globals to Start ups
• Execution of customer related tasks in close collaboration with colleagues in the group and across the entire organization

Senior Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

You will become a process owner of one or more of our production processes in SFI. This means that you will be responsible for, among other things, validation documentation, revalidations, and risk assessments for the specific process.

Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

Together with the rest of the team, you will be responsible for the daily support of our production lines. You will learn our processes in detail and gain a good overview of the documentation used in production.

Product Portfolio Manager, Arla Foods Ingredients - Aarhus

Together with the rest of the team you will make raw material scenario analyses and identify potential challenges to have a fact-based discussion and enable better decision-making.

In short, your responsibilities and tasks include:

• Become a trusted portfolio partner to the commercial organization
• Provide raw material priority recommendation in S&OP and other key-forums

Account Manager – Denmark

Actief Hartmanns is searching for an experienced and enthusiastic candidate for the position of Account Manager.

Are you ready to step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what ZEISS employees are doing every single day – in order to set the pace through innovations and enable outstanding achievements. After all, behind every successful company are many great, fascinating people.

Full training in our products, systems and processes is provided. We offer continuous professional development and the opportunity to work as part of a global team with a wide range of career development opportunities.

Senior QA Specialist

The Senior QA Specialist for Radiometer is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms. This is done by cooperating, supporting, facilitating, training, and communicating towards the best results with partners in R&D.

This position is part of the QA Design Control department, hybrid based and located in Brønshøj. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

QA Specialist

You will be responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms.

You will have the opportunity to:

• Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
• Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development.

Laborant til Incoming QC

Vil du bidrage til diagnostik af cancer og gøre en forskel for patienter? Er du detaljeorienteret og lægger vægt på korrekt produktion og dokumentation? Trives du i et spændende produktionsmiljø?

I Incoming Quality Control (IQC) foretager vi kvalitetskontrol af råvarer og Outsourced supplier materials, hvor vi sikrer at den korrekte dokumentation er tilstede, før vi godkender råvarerne til produktion. Desuden foretager vi test af nogle råvarer, ELISA tests, Bioburden og analyser af vandprøver.

Hverdagen består hovedsageligt af grundig kvalitetskontrol af dokumentation og reviews samt laboratoriearbejde, men vi prioriterer også tid til løbende forbedringer af vores arbejdsgange og processer.