29 job matcher din søgning
PHARMADVICE ApS, Søborg
Ønsker du meningsfyldte opgaver og mulighed for at dygtiggøre dig? Søger du gode kunder, mange varierede opgaver og har du erfaring inden for Regulatory Affairs (RA) og Pharmacovigilance (PV)?
Så er det dig, vi søger som vores nye kollega hos PharmAdvice.
- Sparring og udarbejdelse af registreringsstrategier
- Nationale og DCP-/MRP-ansøgninger
- Variations- og genregistreringsansøgninger
Vil du arbejde med den nyeste teknologi og blive udviklet til en af Danmarks førende specialister? Som vores nye serviceingeniør spiller du en afgørende rolle i at sikre funktionaliteten af medicinsk udstyr til bekæmpelse af sygdom.
Du bliver tilknyttet vores team på Sjælland og vil primært være i kontakt med vores sjællandske kunder. Du begynder dagen hjemmefra og tager typisk direkte på serviceopgaver. Nogle opgaver er planlagte serviceeftersyn eller installationer, mens andre kan være akutte serviceopgaver. Selvom du løser de fleste opgaver alene, så har du altid dine gode kolleger, din servicechef og vores internationale helpdesk, du kan søge information hos og sparring igennem.
Cook Medical, Bjæverskov
Brænder du for teknik, og vil du være med til at udvikle nye og forbedre eksisterende produkter til behandling af patienter med blodkarsygdomme? Cook Medical søger en ingeniør, gerne med kendskab til medicobranchen, som har lyst til at være en del af et internationalt miljø og udvikle innovative løsninger, som giver mennesker over hele verden en bedre livskvalitet.
Dine arbejdsopgaver vil være at
- udarbejde den nødvendige produktdokumentation herunder kravspecifikationer, testplaner og risikoanalyser, usability- dokumentation samt anden projektdokumentation
- indsamle krav til nye produkter og omsætte disse til produktkoncepter
- forestå fremstilling og test af prototyper i samarbejde med udviklingsteamet
Coloplast A/S, Humlebæk
As the local medical strategy expert, you will manage a variety of medical marketing activities and projects, providing medical expertise in the product development and product launches. Furthermore, you will be supporting the business with evidence, education and medical knowledge for Global Marketing as well as Coloplast subsidiaries.
Medical Marketing is a diverse group of currently 16 highly experienced specialists, who take great professional pride in delivering quality to, learning from and collaborating with our customers and the Coloplast organisation.
Some of your key focus areas are:
- Communicating clinical data resources and developing sales and educational tools to optimise the use of clinical studies to improve the standard of care for consumers
- Creating partnerships with key opinion leaders (KOLs) and other health care professionals (HCPs) to foster ambassadors for our clinical direction
Ascendis Pharma, Hellerup
Then we would love to have you onboard Ascendis Pharma Global IT and invite you to become part of a very exciting journey. You will have good development opportunities in a very flexible environment where “the way we do things here” is open for discussion.
As IT Compliance Manager you have a deep understanding and experience from GxP IT Quality Management perspective so that you can design our future IT Quality Management processes and controls.
Your main responsibilities are:
- Continuous Improvement of our IT QMS in corporation with the IT organization and Ascendis Pharma QA (GxP), Legal Compliance function (GDPR) and Finance function (SOX)
- Manage the continuous improvement and execution of our operational SOX controls
- Guide IT organization and line of business on quality management aspects
Siemens Healthcare AS, Ballerup
We are looking for a bright mind eager to join a dynamic and highly motivated team, in which you will work closely with colleagues from Sales, Customer Service, and Project Management among others. You will work towards establishing closer cooperation between Siemens Healthineers and our customers, and be a part of our continuous efforts to strengthen our relations with our customers in Denmark and the Nordic countries.
As MR Physicist in Siemens Healthineers in Denmark it will be your responsibility to maintain a good and close collaboration with the leading hospitals in Denmark within MR research and innovation. Your main responsibilities will be to:
- Deliver high-end MR application support to our customers
- Offer support to research and innovation projects at the hospitals
- Prepare and implement Master Research Agreements (MRA) with leading hospitals in Denmark
Our Professional Services organization is developing rapidly, so we are looking for dynamic and committed Field Service Engineers to service our customers all over Denmark.
We offer an exciting and challenging job in an efficient and dynamic team with excellent opportunities for professional and personal development in an international and growth-oriented company. Excellent employment conditions, an attractive salary package and an informal work environment.
The job responsibilities include:
- performing all tasks in connection with installation, preventive maintenance, and emergency checks of our instruments
- delivering unique customer support of consistent high quality
- close cooperation with Product Specialists, IT Specialists, Sales Representatives, etc.
Interacoustics A/S, Middelfart
Would you like to use your skills and knowledge of management and regulatory affairs processes to manage an international team of highly qualified regulatory affairs specialists?
In your new role, you will be in close contact with the Sales, R&D and Product Management functions in the companies in the Diagnostic Division. The division consists of several individual brands, including Interacoustics, placed in Denmark, UK, USA and Germany. Your role requires a close collaboration with these brand and their local representatives in the markets where we register and sell our products.
Your main responsibilities will be:
- Management of the multi-site Regulatory Affairs team.
- Support and challenge our business managers in Diagnostic Division as well as distributors worldwide in questions regarding product registrations.
- Ensure a structured approach to product registration.
Unique Human Capital recruiting on behalf of Ascendis Pharma A/S in Hellerup
Great influence on a newly established department
As Manager Process Validation at Ascendis Pharma, the main criteria of success will be, in cooperation with CMC, to establish and ensure reliable and robust chemical manufacturing processes at CMOs that are ready for PPQ and eventually market supply for intermediates and drug substance in one of Ascendis Pharma’s development projects. In addition, you will be a value-adding resource, actively contributing within the CMC and PS project teams on challenges related to chemical processes and manufacture.
Your main responsibilities are:
- External manufacturing of peptide conjugates, including solid phase synthesis
- Pre-PPQ and PPQ activities
- Establishment of continuous process monitoring programs for commercial manufacturing
Senior Clinical Trial Manager
Zealand Pharma A/S, Glostrup
The department is part of Clinical Development and is composed of a dynamic team with enthusiastic and professional colleagues. We have an open and respectful environment encouraging knowledge sharing and where we welcome new ideas.
Due to the high number of new trials that we will initiate, we are seeking a new colleague to join the glepaglutide team.
The successful candidate will be:
- Responsible for designing, planning, conducting and reporting of clinical trials
- Responsible for coordinating collaborations with CROs and leading contract negotiations with CROs
- Responsible for risk assessment of the clinical trials and the development of sponsor oversight plans
Unique Human Capital recruiting on behalf of Ascendis Pharma A/S in Hellerup
Make a difference in a fast growing biotech company
As Director Downstream Manufacturing at Ascendis Pharma the main success criteria is to participate in building up the function in Product Supply, to assure a smooth tech transfer from Development to Commercial Manufacturing and to establish close and high-standard cooperation with the CMOs used by Ascendis Pharma.
The Director Downstream Manufacturing reports to the Senior Director Drug Substance Manufacturing and will be part of a very dedicated and experienced team.
For a Phase 3 project, the Director will be drug substance responsible (downstream) for the commercial manufacturing process and will be responsible for outlining pre-launch activities, post PPQ activities at the CMOs manufacturing intermediates and drug substance.
Radiometer Medical ApS, Brønshøj
I dette job indtager du stolen i kontorlokalet placeret tæt på den travle produktion, hvor der bl.a. arbejdes med automation, dispenseringsmoduler, lim, scannere og ovne. Udstyret bruges som led i produktionsprocessen af vores sensorcasetter, som er en uundværlig del af vores diagnostiske apparater.
Dine arbejdsopgaver og ansvarsområder består i optimering af produktionen ved brug af LEAN-værktøjer med henblik på at:
- Reducere lead time/gennemløbstid
- Forbedre produktiviteten
- Mindske spild
AHOC A/S søger for kunde i Ballerup
AHOC A/S søger en QA/RA-ingeniør indenfor medical device-området til en konsulentvirksomhed, der rådgiver nogle af landets største pharma- og biotekvirksomheder indenfor projektering og validering af produktionsudstyr. Siden starten af 2017 har virksomheden udført forskellige rådgivningsopgaver indenfor medical device-området og ønsker nu at udvide dette område.
Arbejdsopgaverne vil være meget varierede, men vores fokusområder vil være rådgivning indenfor følgende områder:
Medical device documentation
Bistå virksomheder med udarbejdelse af den tekniske produktdokumentation iht. myndighedskrav for designkontrol (f.eks. 21CFR820.30). Sikre at det tekniske niveau for dokumentationen opfylder myndighedernes forventning.
Gennemførelse af kvalitetsaudits internt i virksomhedernes organisation fortrinsvis iht. ISO 13485 og cGMP.
MEQU A/S, Copenhagen
°MEQU is currently looking for a QA/RA specialist to join the team at an exciting stage in the company’s development.
°MEQU has developed an award-winning, portable blood warmer for use by emergency services, hospitals and military forces. We are continuously working with the authorities in Europe (CE) and the USA (FDA) and are looking to strengthen the in-house QA/RA expertise.
The tasks/responsibilities will be shaped to fit the skills/interests of the successful candidate, but it is expected that he/she will:
- have responsibility for maintaining and optimising °MEQU’s QMS
- lead activities in support of ISO13485 and MDR compliance
- take ownership of the FDA 510k approval process
Natus Medical Denmark ApS, Taastrup
Would you like to be part of a fast growing multinational - an industry leader providing medical solutions to people around the world? Do you enjoy handling product approvals worldwide?
As our new Regulatory Affairs Specialist, you will be responsible for maintaining registrations for Otometrics products in all international markets. Utilizing your knowledge of international regulatory requirements, you will support our product design and development teams to ensure that our products meet regulatory compliance standards for medical devices.
Your duties and responsibilities will include:
- Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
- Plan, execute and maintain medical device product registrations and clearances in all international markets.
Thermo Fisher Scientific, Roskilde
Do you thrive in a dynamic, international leading company, and are you motivated by improving ways of directing and developing regulatory affairs? Are you committed and self-driven, and would you like an influential role where you will be enhancing performance whilst applying your Regulatory expertise within Medical Devices? Then you may be the one we are looking for.
We are now looking for a Regulatory Affairs Manager with real integrity and can-do-attitude to assume responsibility for the development as well as setting the direction within the regulatory affairs.
As Regulatory Affairs Manager you will be key in the development of the regulatory strategy for Roskilde and Europe, and at the same time provide RA guidance and support to ensure continued accuracy and compliance with international standards, internal procedures, applicable regulatory and legislation.
Farmaceut – kan være en yngre eller en mere erfaren kandidat – søges hurtigst muligt til stillingen som Regulatory Affairs Officer.
Targeting v/Jeanette Juhlin, Herlev