Regulatory Affairs Expert for Innovative Product Development

1 month ago


Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

Are you a strategic and detail-oriented professional looking to make a lasting impact on new product development? As a Regulatory Affairs Expert at Ambu A/S, you will play a key role in shaping the regulatory strategy for our innovative products. We are seeking a skilled and proactive individual to join our dynamic team.

About the Role

This is a fantastic opportunity to work in a collaborative environment where you will have the chance to develop and maintain professional relationships with cross-functional teams, including R&D, Clinical, Marketing, and QA. Your main responsibilities will include:

  1. Developing and implementing regulatory strategies for new product development and design changes;
  2. Maintaining product approvals and changes;
  3. Translating regulatory requirements into product requirements and participating in knowledge-sharing groups across the organization;
  4. Maintaining and improving regulatory processes.

We are committed to delivering high-quality products that meet the needs of healthcare professionals and patients worldwide. To achieve this, we rely on talented individuals like you who share our passion for innovation and excellence.

About You

To be successful in this role, you will need:

  • A Bachelor or Master's degree in a relevant field of natural science, such as biomedical engineering;
  • Excellent analytical and problem-solving skills;
  • Strong communication and collaboration skills;
  • The ability to work independently and as part of a team;
  • Fluency in English, both written and spoken.

In return, you can expect a competitive salary of around $90,000 - $110,000 per year, depending on experience, plus a range of benefits, including opportunities for professional development and growth within the company. If you are motivated by the prospect of working on cutting-edge projects and making a real difference in the lives of others, then this could be the perfect opportunity for you.



  • Ballerup, Ballerup Kommune, Denmark Demant Polska Full time

    EPOS, a leading audio and video solutions company, is seeking an experienced Global Regulatory Affairs Manager to join their team in Demant Polska. The ideal candidate will have a strong background in regulatory affairs and compliance within the consumer electronics industry.Job DescriptionThis is an excellent opportunity for a skilled professional to lead...


  • Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Strategist to join our dynamic team at Ambu A/S. As a key member of our Regulatory & Clinical Affairs department, you will play a critical role in shaping the regulatory strategy for new product development and design changes.Main ResponsibilitiesDeveloping proactive regulatory support for new...


  • Ballerup, Ballerup Kommune, Denmark Unique Human Capital AS Full time

    Are you passionate about advancing cancer treatment through antibody drug product development?Symphogen, a leading player in the field, is seeking a highly skilled Drug Product Development Expert to join their team. As a key member of this dynamic group, you will play a crucial role in the development of innovative therapeutic products for cancer and...


  • Ballerup, Ballerup Kommune, Denmark Pfizer, S.A. de C.V Full time

    Medical Affair Role OverviewPfizer in Denmark seeks a highly skilled Medical Affairs Scientist to support the growth of our oncology franchise.About the JobWe are looking for an expert in medical affairs with strong communication and interpersonal skills. As a Medical Affairs Scientist, you will play a crucial role in providing medical and scientific support...


  • Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

    Job DescriptionIn this pivotal role as Regulatory Safety Expert, you will play a crucial part in ensuring the safety and efficacy of our medical devices, specifically hearing aids. Your primary responsibility will be to conduct thorough biological evaluations of our products under development, working closely with our Materials & Reliability Development...


  • Ballerup, Ballerup Kommune, Denmark Ambu AS Full time

    About the RoleWe are seeking an experienced Embedded Software Developer to join our team in Ballerup, Denmark. As an innovation expert, you will be responsible for developing innovative products that save lives and improve patient care.Key ResponsibilitiesDevelop high-quality code in C and C++Collaborate with the embedded SW team and the application SW team...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking an experienced and inquisitive scientist with a strong digital skill set to join our team as a Senior Regulatory Toxicologist. This one-year temporary position is based in Denmark, and you will be part of our versatile team operating in a challenging and ever-evolving environment.Key ResponsibilitiesYou will prepare toxicological...


  • Ballerup, Ballerup Kommune, Denmark Unique Human Capital AS Full time

    Job DescriptionThe Drug Product Scientist role at Symphogen is an exciting opportunity to advance biopharmaceutical innovation and improve the lives of patients.This challenging position involves contributing to the development of antibody-based therapeutic products for cancer and inflammatory/autoimmune diseases. As a member of the Drug Product Development...


  • Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

    About the Role">">GN Store Nord A/S is seeking a talented Product UX Designer to join our Product UX team in Ballerup, Denmark. As a Product UX Designer, you will play a pivotal role in designing intuitive, user-centric physical interfaces for our cutting-edge audio/video solutions.">Your Key Responsibilities">You will be the advocate for creating...


  • Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

    In this role, as a Biological Evaluation Specialist, you will play a crucial part in ensuring the biological safety of our medical devices. Your primary responsibility will be to perform thorough biological evaluations of our products under development, working closely with our material expert colleague to identify potential regulatory risks associated with...

  • IT Compliance Expert

    2 weeks ago


    Ballerup, Ballerup Kommune, Denmark GN Group Full time

    About the Role:We are seeking an IT Compliance Expert to join our team at GN Group. In this role, you will play a crucial part in ensuring that our IT systems and software applications meet the necessary external and internal regulatory and compliance standards.Key Responsibilities:Develop and implement validation plans, protocols, and reports for IT systems...

  • Purification Team Lead

    2 months ago


    Ballerup, Ballerup Kommune, Denmark Unique Human Capital AS Full time

    Antibody Therapeutic LeaderSymphogen A/S, a leading biotech company and the Antibody Center of Excellence, is seeking an experienced Purification Team Lead to join our innovative team.The ideal candidate will have extensive hands-on experience in downstream process development of antibody products and managerial expertise. They should be well-versed in novel...


  • Ballerup, Ballerup Kommune, Denmark Pfizer Full time

    Job DescriptionPfizer, a leading global pharmaceutical company, is seeking an Expert Oncology Medical Advisor to join its team in Denmark. This exciting opportunity offers the chance to make a meaningful impact on cancer patients' lives while working with a talented and diverse group of professionals.About the RoleThe successful candidate will be responsible...


  • Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

    About the RoleWe are seeking a skilled Software Developer to join our DataHubs & Activation team, focusing on driving digital exploration and innovation. The ideal candidate will be part of a project-based team where curiosity, speed, and agility are key to explore, prototype, and validate new digital opportunities and technologies.In this challenging and...


  • Ballerup, Ballerup Kommune, Denmark Unique Human Capital AS Full time

    About the RoleWe are seeking an experienced Antibody Product Development Lead to join our team in Ballerup, Denmark. As a key member of our Purification team, you will lead the downstream process development of monoclonal antibodies and novel antibody formats.Key Responsibilities:Timely material supply supporting lead candidate selection in the discovery...

  • Compliance Assistant

    4 weeks ago


    Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

    Are you a skilled professional with an understanding of business ethics and compliance? We are seeking a Compliance Assistant to join our experienced compliance team in an innovative environment at a global tech company.The role involves assisting the Director of Group Business Ethics & Compliance in preparing responses to internal and external information...


  • Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

    Role OverviewWe are seeking a seasoned Product Development Manager to lead the development of our next generation headset products. As a critical member of our team, you will play a key role in shaping the future of our Consumer Electronics portfolio.The ideal candidate will have a strong background in consumer electronics engineering and design, including...


  • Ballerup, Ballerup Kommune, Denmark Pfizer Full time

    Pfizer Seeks Cancer Research ExpertJoin a talented team at Pfizer Denmark as we push the boundaries of cancer treatment. We're looking for an experienced Medical Affairs Scientist to lead our oncology efforts in Denmark.As a key member of our medical affairs team, you will be responsible for providing scientific and medical support to healthcare...


  • Ballerup, Ballerup Kommune, Denmark Randstad AS Full time

    We are seeking a highly skilled Sales Solutions Expert to join our team at Aalberts hydronic flow control.About the RoleAs a Sales Solutions Expert, you will be responsible for engaging in daily dialogue with customers to understand their needs and develop tailored solutions. You will work closely with the sales function, service function, and technical...


  • Ballerup, Ballerup Kommune, Denmark Demant Polska Full time

    We are looking for an experienced and skilled Production Test Systems Developer to join our team at Demant Polska, a world-leading hearing healthcare and technology group. This is a unique opportunity to work with innovative technologies and contribute to the development of better, faster, and more robust production test systems for hearing aids.As a...