Ambu is a global company with ambitious growth targets. Our ability to identify and adapt to the evolving regulatory landscape is essential for continuous growth within our business areas. Therefore, Ambu is looking for a Senior Regulatory Affairs Professional that will be responsible for implementing regulatory requirements and setting the strategic agenda for our products and processes within RA.
Ensure company compliance with regulatory requirements
As part of an organisation with short lines of decision-making, you will have a unique opportunity to influence the development of Regulatory Affairs and set the strategic direction and framework for us to comply within the different regulations. You will, therefore, have the overview of the regulatory requirements and reviewing new theories, regulations or laws, and to put it into practice by empowering both RA professionals and other relevant parts of the organization. This is done by acting as sparring partner to the rest of the RA team, updating regulatory procedures, communication of regulatory requirements and strategies and by knowledge sharing e.g. by chairing workshops. Communication is therefore a key part of your assignments.
Your primary responsibilities will be to:
- Act as a regulatory sparring partner for RA colleagues both in development projects and in relation to life cycle management of approved products, to ensure regulatory compliance and alignment across all products and processes
- Ensure Ambu successfully implements new EU and US medical device legislation by setting the strategic direction and framework
- Contribute to global regulatory strategies and empower company and project team decisions
- Provide guidance on technical file content and design control requirements
- Incorporate current regulatory requirements in the quality system and ensuring that Ambu’s products and processes comply with relevant regulatory requirements.
- Corporate support to local regulatory affairs departments at our manufacturing and innovation sites
You will join the Corporate Regulatory Affairs department within our RA Operation team, but you will work closely with the rest of the Corporate Regulatory Affair department and with the QA-Engineering department, local regulatory affairs departments at our manufacturing sites, R&D, Marketing, and other departments.
Assertive RA professional with good communication skills
It is a requirement that you have minimum 5+ years of experience with Regulatory Affairs from the medical device industry and that you have experience with the EU legislation for medical device and US-FDA requirement for design control. Experience working with ISO 13485, Risk Management, certification and labelling of kits is a plus. Also, you must have good understanding of the 510(k)-process. In terms of education, you must hold either a bachelor’s or a Masters’ degree in the field of science.
You are kind of a detective and can find solutions by taking a deep dive into regulations and guidelines when needed. To support decision making, you are able to communicate requirements and solutions in a clear matter and have the ability to navigate many agendas and stakeholders. We want you to share your knowledge and take lead. In addition, you must have an analytical and structured approach to your work and the capacity to prioritise in order to meet deadlines.
Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us, you will get the opportunity to work in an international head office with an informal working environment.
We offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.
How to apply
If you are ready to apply for the position, please apply as soon as possible. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad will be online until 16 of August and interviews will be held shortly thereafter.
If you have any questions about the position, you can contact Katrine Dalsgaard Ajbro, Head of Regulatory Affairs Operation, by phone +45 26779750.
Your application will be treated with confidentiality.
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