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2 Regulatory and Marketing Compliance Managers

Har du interesse for og meget gerne erfaring med Regulatory Affairs – og helt optimalt med Marketing Compliance – og vil du gerne arbejde mere målrettet med Marketing Compliance?

Dine arbejdsopgaver bliver bl.a.:

• Compliance review af marketingaktiviteter og -materialer for den farmaceutiske industri og anmeldelser til Etisk Nævn for Lægemiddelindustrien
• Oversættelser af regulatoriske og medicinske dokumenter (dansk/engelsk)
• Andre regulatoriske opgaver svarende til opgaverne i et dansk datterselskab: gennemgang og opdatering af produktinformation, regulatorisk review af artwork m.v.

Erfaren QA-Specialist – til frigivelse af produkter

Stillingen byder på et bredt udsnit af QA-opgaver og flere kan komme til, så du får gode muligheder for at videreudvikle dine QA-kompetencer.

Opgaverne:

• Selvstændig frigivelse af PKC’s produkter og behandling af afvigelser og håndtering af ændringssager
• Sparringspartner for QA-gruppen, QC-gruppen og produktionen

Du får ansvar for og stor medbestemmelse over dine opgaver. Der er tid til fordybelse, men der er også dage, hvor det går rigtig stærkt, og opgaverne blev andre end dem, du havde planlagt og forventet.

(Senior) Drug Substance Specialist

We are currently seeking a (Senior) Drug Substance Specialist who is energized by collaborative and fun teamwork, excels in handling complex tasks, and enjoys continuous learning.

Your responsibilities will include late-stage drug substance development, up-scaling and process validation as well as support in the commercial phase. Effective coordination with external partners is a significant aspect of this role.

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.

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

Application Specialist – Beverages

Are you passionate about product development within all types of beverages from premium organic CSD's to flavored spirits?

You will work in a high-paced, collaborative and energetic environment optimizing key elements of beverage applications such as taste, stability, preservation and appearance with the goal to design the perfect balance between these elements.

Senior Medical Writer

Do you want to work in a global context and according to the highest standards of current practice to provide new products to patients with unmet medical needs?

As a Senior Medical Writer, you will be responsible for delivering submission-ready documents and take the role as lead medical writer on specific assignments. In addition, you can look forward to joining a diverse organisation shaped by cross-functional and global collaboration – and a focus on continuous transformation to support the future needs of clinical development.

Technical Specialist, Product Quality, Nourish (Maternity cover, 12 months)

Are you an enthusiastic, motivated and detail-oriented professional with a desire to work in a team of colleagues with great technical competencies within production, regulation and processes?

Your core responsibilities:

• Handling deviations for products manufactured at our factories.
• Handling of product quality related complaints.
• Coordinate and implement customer-specific requirements. Maintenance of master data in various IT systems, including SAP.

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.

Regulatory Affairs & QA Lead

Har du lyst til at blive en del af en spændende arbejdsplads, som opererer globalt med nogle af markedets bedste produkter?

Som vores Regulatory Affairs & QA Lead bliver du en del af et velfungerende team med 5 engagerede kolleger, der hver dag arbejder målrettet og brænder for deres arbejde.

Der kan være mange indgangsvinkler til jobbet men du skal have erfaring med medicinsk udstyr, være omhyggelig, energisk og brænde for det regulatoriske arbejde.

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

Technical Writer to GE HealthCare Denmark

Join GE HealthCare to help develop high quality instructions for use for our ultrasound scanners, transducers, and reprocessing methods in compliance with rules and legislation in various countries. This is your opportunity to become part of an innovative team where your work has a real impact on people’s lives around the world.

Our Technical Documentation team consists of six dedicated and passionate specialists with a mix of seniority, educational backgrounds, and nationalities. Our Technical Writers develop and maintain the user documentation for our high-performance equipment.