Head of Regulatory Affairs Compliance and ProcessesCity: Ballerup
State:
Country: Denmark
Business Area: Regulatory Affairs
Department: Regulatory & Clinical Affairs
Employment Type: Full-time
Are you a seasoned leader with a global perspective, who can set direction? Has an anchor point in your career been in regulatory affairs and pragmatic leadership? Do you carry experience in medical device development and lifecycle management?
Then this might be your defining moment. Apply today and join us for a career #ForeverForward!
Key responsibilities
In this role, you will be leading a stellar team with competencies stretching from regulatory processes and UDI to labelling standards. The team has base both in Denmark, but we currently also have 5 team members in our R&D site in Penang, Malaysia.
Your main responsibilities will include:
Leadership and direction setting of the team
Developing the competencies within the team
Ensuring smooth implementation of processes with a business-centric mindset
Be an anchor point for sparring on the below bullets
The team's responsibilities, which you will oversee includes:
Driving compliance projects globally, including EUDAMED/UDI
Owning the regulatory sourcing agenda, in alignment and collaboration with procurement
Drive intelligence processes in close collaboration with the further regulatory department
Developing and maintain regulatory processes, along with stakeholders from across the business
Setting direction for the labelling team, consisting of experts in the field
Auditing handling and coordination towards authorities
Suggested candidate profile
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:
Are characterized by your pragmatic leadership style and open-mindedness towards challenges
Can keep your eyes on the target and being able to zoom-out – and at the same time remaining decisive in cohesion
Have a regulatory background within the medical device industry
Have led teams within e.g. regulatory affairs, quality management, R&D, or similar discipline
Have an educational background with relevance to life sciences – what we're truly interested in is your drive and experience
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 great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.
Apply for a career #ForeverForward
Questions? Reach out to Elsebeth Aagaard, VP Regulatory & Clinical Affairs.
The Talent Attraction Partner will engage with candidates on an ongoing basis, hence we encourage you not hesitate, and rather apply!
About AmbuAmbu 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.
For more information, please visit ambu.com or follow us on LinkedIn.#J-18808-Ljbffr