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Specialist, Regulatory Affairs (Temporary Position)

As Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.

Further, your main responsibilities include to:

• Gather information and documentation for variation applications
• Update dossier sections

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.

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.

Technical/Operational Project Manager

Are you ready to leave your mark on a company deeply committed to innovation and pioneering water purification solutions?

We’re seeking a fresh perspective to contribute new ideas and energy to our strategic operational team based in Kalundborg. As our Operational Project Manager, you’ll play a pivotal role in the expansion phases of our projects.

You will have the chance to tackle exhilarating challenges and help shape the company’s future as we expand our existing facilities and construct new ones, both domestically and internationally.

Postdoc in Biotechnology – DTU Chemical Engineering

Department of Chemical and Biochemical Engineering invites applications for a position as Post Doctoral Fellow to be hired within the frame of a project on biogas conversion to single cell protein in the form of methylotrophic bacteria, where optimising synergistic microbial interactions is a key element.

Project focus is on recovery of nutrients from the biogas digestate by microbial or electrochemical methods.

Clinical Evidence Lead

Do you want to:

• Lead the clinical development and clinical data strategy across application areas
• Lead the wording, substantiation, and documentation of clinical claims for regulatory compliance and commercial utilization
• Contribute to the clinical evidence activities in development projects and give input to PMCF

The main responsibilities of your new team are to drive the clinical strategies to ensure timely execution on clinical deliverables to support regulatory submissions and commercial strategies.

Senior Clinical Scientist

Do you want to:

• Execute clinical evaluation and documentation activities, including clinical input to PMCF and PMS.
• Provide clinical support to global registrations.
• Support and drive ad hoc clinical activities and problem solving

The main responsibilities of our Clinical Development team are to drive the clinical strategies to ensure timely execution on clinical deliverables to support regulatory submissions and commercial strategies.