Regulatory Affairs Professional

vor 6 Monaten

Augsburg, Deutschland Ambu Vollzeit

Business Area: QA/RA- Employment type: Full-time**Regulatory Affairs Professional**

Are you looking for independence in your job, variance and a working day characterized by exciting new challenges? Would you like to be part of a great team in Ambu’s Regulatory Affairs department and ensure that we meet regulatory requirements?

Then Ambu might be your next career move.

**Our purpose is ‘together, we rethink solutions to save life and improve patient care’**

Our aspiration is to be the most customer-centric company in our field and to expand our leading position within single use endoscopy solutions. Our four strategic focus areas are: Providing innovative solutions for true customer needs, to excel in execution across the value chain, take leaps towards a sustainable future, bring people together in one shared culture. In addition, Ambu is one of the first companies to be fully compliant with the new EU Medical Device Regulation (MDR).

**Executing efficiently**

As part of an organization with short lines of decision-making, you will have a unique opportunity to have influence on your own job. You will be implementing regulatory strategy in product development and ensure submissions in EU, US and Canada. You will experience a varied working day in a dynamic organization. You will work closely with your colleagues, particularly colleagues in Denmark, Germany, and Asia.

**A job with impact**

Your main responsibilities will be:

- Providing professional and proactive regulatory support in innovation projects
- Defining agile regulatory strategies within innovation projects
- Engage in pre-submission request with authorities
- Compilation of submission files
- Handling submissions to EU, US and Canada incl. ensuring timely response to authorities to support fast approval
- Providing regulatory input for lifecycle management activities

Being part of cross functional teams, you will be working closely together with stakeholders from among others R&D, QM-Engineering, Marketing and Clinical Department.

**Key competences**

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

- You hold a master's degree in a relevant field of science for example engineering, biology, or another natural science field.
- To succeed in the job, you are collaborative, have a structured approach, are proactive and have an eye for the detail while keeping the oversight.
- Experience from working with medical devices and design control will be an advantage.
- Ambu is a global company and English is our corporate language, which requires that you speak and write English at a high level. You will use English every day in your job.

**Ambu - a visionary and international workplace where your efforts matter**

We offer a wide range of professional, social, and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.

**When to apply**

**About Ambu**:
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

  • Internationale Geschäftsentwicklungskoordinator

    vor 3 Wochen

    Augsburg, Bayern, Deutschland MED-EL Medical Electronics Vollzeit

    Beschreibung des Arbeitsplatzes:Wir suchen einen internationalen Geschäftsentwickler, der unsere Chirurgischen Roboter und Software erfolgreich auf dem Markt zu platzieren hilft.Aufgaben und Verantwortlichkeiten: Als zentrale Verbindung zwischen Vertrieb, Regulatory Affairs, Produktmanagement, Marketing und anderen Abteilungen agiert dieser Job, um eine...

  • Leitung (M/w/d) Der Koordinierungsstelle Für

    vor 4 Monaten

    Augsburg, Deutschland Universitätsklinikum Augsburg Vollzeit

    Am **Dekanat der Medizinischen Fakultät **suchen wir zum nächstmöglichen Zeitpunkt in Vollzeit eine Leitung (m/w/d) der Koordinierungsstelle für klinische Studien (KKS). Die Stelle ist teilzeitfähig, sofern durch Jobsharing die vollumfängliche Wahrnehmung der Aufgabe gesichert ist. **Ihre Aufgaben** - Weiterentwicklung und Konsolidierung der Struktur...

  • Senior Clinical Product Training Specialist

    vor 3 Wochen

    Augsburg, Bayern, Deutschland MED-EL Medical Electronics Vollzeit

    Company OverviewMED-EL Medical Electronics is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide.Salary: The estimated annual salary for this position ranges from...

  • Product Manager

    vor 2 Monaten

    Augsburg, Deutschland GULP – experts united Vollzeit

    Get startednow as a Product Manager !We are currently looking for a part-time Product Manager (20-25 hours/week)on behalf of our business partner, a leading company in the color and specialty chemicals industry near Augsburg . Apply today and start your new job tomorrow! Diversity is actively practiced at our company, which is why we welcome...

  • Senior Drone Systems Design Engineer

    vor 3 Wochen

    Augsburg, Bayern, Deutschland Newton Dynamics GmbH Vollzeit

    Job DescriptionWe are seeking a highly skilled Senior Drone Systems Design Engineer to join our R&D team at Newton Dynamics GmbH. This is an exciting opportunity to be part of a dynamic startup shaping the future of air-based delivery.About UsAs a robotics and automation expert, you will contribute to the development of cutting-edge drone technology,...

  • Flight Termination Systems Engineer

    vor 7 Monaten

    Augsburg, Deutschland OHB Vollzeit

    At Rocket Factory Augsburg (RFA) we have one goal: create low-cost, flexible and reliable access to space. We specialize in the creation of small launcher solutions designed for deploying satellites into Low Earth Orbit (LEO) and beyond. Together with you, we want to revolutionize space services and help enhance life on Earth. Sounds interesting? Then join...

  • Design Owner, Anaesthesia

    vor 2 Monaten

    Augsburg, Deutschland Ambu Vollzeit

    Do you want to be responsible for further improving our successfully launched products? Do you carry experience from the MedTech industry, with a good understanding of Product Design? Are you a natural cross-collaborator, who thrives in an international environment? **A job with global impact** Ambu A/S is currently looking for an experienced Design Owner...

  • Senior Usability Specialist

    vor 2 Monaten

    Augsburg, Deutschland Ambu Vollzeit

    Are you an experienced Senior Usability Specialist looking for more autonomy in your role, with the chance to make a significant impact on Ambu’s product development? **Do you have a passion for user testing medical devices?** We offer a dynamic and challenging position where you will help ensure our ongoing commitment to delivering high-quality...

  • Civil Engineering Professor with a Focus on Planning

    vor 4 Wochen

    Augsburg, Bayern, Deutschland Hochschule Augsburg Vollzeit

    OverviewThe Technical University of Applied Sciences Augsburg, with its 7,100 students, is an important economic engine and innovation hub for the region. Over 600 employees excel in teaching, research, and administration.We are seeking a professor with expertise in civil engineering planning to join our faculty at the FACULTY OF ARCHITECTURE AND CIVIL...

  • PCB Layout Designer

    vor 7 Monaten

    Augsburg, Deutschland Emerson Vollzeit

    You are a professional looking for an opportunity to expose your skills and grow? Emerson has an appealing role for you! Check out our open position as **PCB Layout Designer (M/F/d) **. As a **PCB Layout Designer (M/F/d) **at Emerson, you will join our highly motivated engineering team in developing and supporting high quality products according to exacting...

  • Professor for Civil Engineering Planning

    vor 3 Monaten

    Augsburg, Deutschland Hochschule Augsburg Vollzeit

    The Technical University of Applied Sciences Augsburg, with its 7,100 students is an important economic engine and innovation hub for the region. Over 600 employees excel in teaching, research and administration. Together we shape tomorrow’s world – creatively and meaningfully. The following part-time position (50%) is available at the  Faculty of...