Regulatory Labelling and UDI Specialist, Senior / Experienced level

Country: Denmark

Location: Ballerup, DK

City: Ballerup

Business Area: QA/RA

Employment type: Full-time

Are you an expert in regulatory labelling and UDI? Do you thrive in global collaboration? Are you a strong communicator, with experience in communication with Notified Bodies and authorities?

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

The role

In this role, you will ensure that Ambu's products and processes comply with relevant regulatory labelling and UDI requirements. As an experienced Regulatory Labelling and UDI Specialist, you will act as the dedicated Subject Matter Expert (SME) for Labelling and UDI, overseeing the strategy, governance, and operational aspects of Labelling requirements and documentation.

You will be part of the Global Labelling team, consisting of 10 skilled and passionate employees, located in Denmark and Malaysia, working mainly with labelling and with UDI implementation. We work in development projects and with products on the market in close collaboration with Global Regulatory Affairs (RA) departments, R&D, QAE/QAS, Labelling Operations, and various stakeholders across Ambu to ensure compliance with relevant regulatory labelling and UDI requirements.

Two days will most likely not look the same, however, you will primarily be indulging in:

• Strategic implantations, of new medical device legislation, setting the strategic direction and framework.
• Acting as an SME and go-to person for regulatory labelling requirements and processes related to medical devices for both LC, RA and other stakeholders within Ambu.
• Providing regulatory labelling and UDI input to global labelling strategies
• Communicating and interacting with Notified Bodies, competent authorities, and regulatory authorities
• Driving the continuous development of work processes and documentation within labelling and UDI.
• Acting as the accountable party for labelling procedures and Standard Operating Procedures (SOPs).
• Taking lead in driving the regulatory labelling intelligence process and serve as Ambu's regulatory labelling and UDI subject matter expert in inspections and audits.

Suggested candidate profile

Setting you up for success is one of our cornerstones. To do so, we imagine you bring experience with labelling compliance, CAPA, have owned NCR’s. Furthermore, you have been an SME and go-to in your field, and have handled e.g., audits, implemented strategies and improvement.

Furthermore, you:

• Have a degree in Engineering, Life Sciences or other relevant discipline
• Have minimum 10 years of relevant experience
• Experience within regulatory affairs and carry interest in or knowledge of labelling and UDI
• Can articulate the organization's strategic vision in a manner that enables others to execute plans, tactics, and actions
• Continually identify and inform appropriate individuals on emerging trends, opportunities, and threats
• Can leverages a well-grounded knowledge of applicable laws, regulations and policies to develop and execute plans and programs
• Can ensure strategies, analyses, and plans consider anticipated long-range requirements and are not just based on the current situation
• Can make informed decisions based on business frameworks and tools and give consideration to risks tradeoffs, timing, and available resources
• Can proactively manage and monitor progress against desired outcomes including working with others to establish and adjust contingency plans, revising and adapting processes, communicating success and learning from mistakes

When to apply

This job ad might be online until 7th of April, however, we will be engaging with applicants on an ongoing basis. Hence, we encourage you to not hesitate and apply!

For further inquiries please contact, Head of Global Labelling, Joan Ascanius, at +45 20963031.

Your application will, of course, be treated confidentially.

Ambu – a visionary and international workplace where your efforts matter

As Ambu is a global company it is essential that you have excellent English skills and that you have a global mindset in relation to both co-workers and business opportunities.

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.