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Regulatory Affairs Specialist

We are on an exciting path of growth and are currently seeking a new specialist to join our team and play a crucial role in ensuring that our operations adhere to relevant regulations and industry standards.

A significant part of your role will be to take regulatory ownership of selected product areas, and ensure the required activities take place, to ensure we are following current regulatory standards for medical device development.

Senior Regulatory Affairs Manager

This pivotal role will involve navigating the complex regulatory landscape associated with technologies for the production of hydrogen, its derivatives and other related technologies. This critical role will also involve ensuring compliance and strategically influencing regulatory development to support our mission.

The ideal candidate will have a deep understanding of energy regulations, a passion for sustainability, and the expertise to guide our company through the evolving regulatory environment.

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.

Produkt- og reguleringsansvarlig / PSRA-officer

Er du klar til at påtage dig en vigtig rolle i udvikling og implementering af den regulatoriske strategi for Bostik og LIP Nordic, der er førende producent af byggematerialer i Norden?

Vi stræber efter at skabe en innovativ og fremsynet arbejdsplads hvor dine idéer kan blive til virkelighed.

Som PSRA Officer er du i frontlinjen af den regulatoriske strategi. Ansvarsområderne inkluderer at produkterne sikrer fuld overholdelse af både dansk- og EU-lovgivning samt overholdelse af krav om miljø og andre regulatoriske regler og sikre at dokumentation har compliance til de højeste standarder.

Head of Business Process Optimization

Do you excel at improving business processes and leading employees in the right strategic direction?

As Head of Business Process Optimization, you will be responsible for building and maintaining our capability to develop, implement, and continuously improve business processes.

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.

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.

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.

QEHS Manager

Unique opportunity to join an innovative biotech company with a proven and sustainable technology on the edge of global expansion.

Do you want to help develop the protein of the future, which will make it possible to feed the world's growing population without damaging our ecosystems?

You will be leading a small team responsible for managing and coordinating all QEHS activities, including certifications, audits, and training. You will ensure that operations are conducted in a safe and efficient manner and in conformance with safety regulations.

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