Regulatory Affairs Device Professional
Novo Nordisk
Exciting Career Opportunity in Regulatory Affairs Combination Products!Do you dream of a career with a global pharmaceutical company built on life-changing innovative investigational medicines and devices? Does working with highly talented and engaged colleagues from many different professional backgrounds and cultures inspire you?Then you could be our new Regulatory Affairs (RA) Device Professional for combination product development in the RA Device department. Apply now for this exciting job opportunity!The position
Novo Nordisk is evolving its portfolio in medical device and drug-device combination product development across an exciting array of innovative products, including biopharmaceuticals and new delivery systems. You will be working closely with colleagues across the organisation, and you will be involved in key activities from early development through to clinical trials and up to Notified Body submission and/or marketing applications.Your responsibilities will include:
You will get a unique opportunity to establish a global network and to enhance your knowledge by participating in innovative medical device and drug-device combination product projects involving highly skilled people – all experts within their field. Most importantly, you will have the possibility to influence your role according to your interests and specialization.You will work in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures, and circumstances. The atmosphere is informal, and good humour is always welcome. Our commitment to innovation also applies to the way we work: We embrace a hybrid workplace, with a blend of in-office and remote work.Qualifications
An ideal candidate is expected to have:
On a personal note, this role requires outstanding communication abilities and a proactive, solution-oriented mindset. Planning and coordination skills to handle complex tasks are also essential attributes.You exhibit a strong sense of self-motivation and demonstrate the ability to make informed regulatory decisions, thereby advancing our regulatory initiatives. With a proactive and innovative approach, you can bring valuable input and set the strategic direction for the project(s).Furthermore, you should be able to communicate complex regulatory topics to a diverse range of stakeholders, spanning from Research & Development to production and marketing, and effectively engaging with health authorities through scientifically informed discourse.
About the departmentRA Device is part of the RA CMC & Device Area in Novo Nordisk. In RA Device, we are responsible for submission planning including applying intelligence and develop regulatory strategy for the medical device and device constituent of drug-device combination projects, to ensure minimum time to market and thus patients. This includes evaluating applicable guidelines, requirements and using external relations and network in your day-to-day work, as well as planning and conduct of regulatory interactions with health authorities.Regulatory Affairs is a truly multi-disciplinary department with high professional standards and excellent opportunities for fast-paced professional development and career progression.Working at Novo Nordisk Søborg, Hovedstaden
Fri, 02 Aug 2024 22:12:00 GMT
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