Senior Regulatory Affairs Professional Job Details | Ambu

Are you the go-to person when it comes to reporting requirements for medical devices? Would you like to play a key role in maintaining Ambu’s continuous regulatory compliance by co-owning the vigilance process? Are you motivated by a broad international landscape with diverse stakeholders?

Then this might be your defining moment. Apply today and join us for a career #ForeverForward!

Ensure compliance within regulatory requirements
As part of an organization with short lines of decision-making, you will have a unique opportunity to influence the development of the vigilance process and set the strategic direction and framework for us to comply within the different regulations. You preferably have a profound and holistic overview of the regulatory requirements for reporting and can put it into practice by empowering peers involved in the vigilance process.

Along with our other Vigilance Specialist, you will act as the vigilance go-to person in the organization, providing guidance, review, and decision-making in relation to reportability, process improvements, knowledge sharing, and communication of reporting requirements. This includes chairing workshops and facilitating internal training.

A job with global impact
In this role, you will have a great sparring partner in our other Vigilance Specialist. Together, you will lead and coordinate the handling of vigilance cases, including the organizational coordination of vigilance investigations with colleagues in various parts of Ambu and external partners. To succeed, you must communicate and partner effectively with stakeholders, whether they are an external partner, authorities, or internal colleagues.

Your primary responsibilities will include:

• Ensuring Ambu successfully implements new legislation for vigilance requirements by setting the strategic direction and framework together with other vigilance colleagues
• Timely reporting of vigilance reports to authorities and handling daily evaluation of complaints for reportability
• Coordination, communication, and record-keeping in case of Field Safety Corrective Actions
• Participating as the Ambu vigilance subject matter expert in inspections and audits
• Taking part in the regulatory intelligence for vigilance and further improving established processes
• Providing corporate support and sparring to local regulatory affairs departments at our manufacturing and R&D sites

You will join the Global Regulatory & Clinical Affairs department within the RA team covering Global Vigilance, and further parts of our portfolio from development to lifecycle management. You will also work with the rest of the Global RA teams, along with the Global Quality, our manufacturing sites, Clinical, Marketing, and other relevant teams.

Proactive and positive professional with good communication skills
Setting you up for success is one of our corner stones. In order to do so, we imagine you bring experience from an RA function within the medical device industry, carrying a global outlook and a broad knowledge of regulatory responsibilities in partnerships across jurisdictions.

Furthermore, you:

• Carry a Bachelor’s or Master’s degree in the field of science; what we’re truly interested in, though, is your MedTech vigilance experience!
• Are characterized by your solution-oriented person – able to deep dive into regulations and guidelines and communication these to team colleagues, as well as non-RA colleagues
• Thrive in collaborating with a broad stakeholder landscape and can challenge when needed
• Like to take lead and do so in a structured manner
• Have an analytical mindset and can prioritize accordingly in order to meet authorities deadlines – and are not be afraid to ask for help when needed

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.

If you have any questions about the position, you can contact Gitte Juel Friis, Head of Regulatory Affairs, by email at gitf@ambu.com.

Your application will be treated with confidentiality.