Clinical Compliance Manager
Are you passionate about and highly experienced in clinical compliance and legislation for medical devices and would you like to play a key role in ensuring this across functions?
At Ambu, we develop, produce and sell medical devices, enabling healthcare professionals to save lives and improve patient care around the world where you will be instrumental in securing our ongoing dedication to quality products.
We are an international department with clinical teams in Denmark, Germany, Malaysia and US. We are part of Global Innovation and have an ambitious innovation agenda and a high focus on supporting the products on the market. We have a positive innovation culture and a tradition for fast completion of activities with a team-oriented mindset.
As Clinical Compliance Manager, you will lead, plan and support clinical compliance activities across Global Clinical Affairs and support both premarket and post market clinical activities for our medical devices worldwide. Over time we expect the Clinical Compliance group to grow, and you are expected to drive such expansion and build the Compliance team under your supervision. The position is based at Ambu’s headquarter in Ballerup, Denmark and you will be reporting to the Senior Director of Global Clinical Affairs.
A global job as an expert and go-to person in clinical medical device requirements
As Clinical Compliance Manager, you will be involved in all aspects of clinical compliance from developing and implementing optimal clinical processes and product documentation according to legislations for clinical development, sustaining and improvement activities, to ensuring hand-on guidance, training and timely communication within Global Clinical Affairs and across the organisation.
The job includes that you will be responsible for developing and communicating the right scientific level when implementing international clinical medical device legislation and regulation during the lifecycle phases of our products. It is therefore important that you ensure that quality, speed and collaboration is balanced together with your hands-on approach as you execute on activities.
Your main responsibilities will be to:
- Serve as the overall subject matter expert and go-to sparring partner in international clinical medical device legislation especially for the EU / US and facilitate clinical compliance across functions.
- Ensure ongoing optimal and lean implementation of international clinical medical device legislations in our clinical processes and related procedures in collaboration with colleagues and management.
- Lead, coordinate and participate in audits on behalf of Global Clinical Affairs.
- Provide clinical input to clinical safety assessments and vigilance reporting.
- Independently prepare and review clinical documentation in terms of compliance and legal principles, to support clinical innovations and product life cycle activities and support network of relevant clinical specialists in relation to projects.
- Be an expert in Clinical Evaluation Reports, literature searches and medical writing incl. relevant medical device guidelines.
- Mentor and train colleagues in gaining relevant knowledge in a learning environment.
International travelling should be expected as a part of the position (10-20 days per year) when possible again.
Key competences
To succeed in this position, you need to have senior level experience in EU / US clinical medical device legislations and guidelines combined with a relevant academic degree, e.g. a MSc in Health or similar.
Candidates with a background within Quality Assurance, Regulatory Affairs, Clinical development processes or similar will have an advantage in the application process. As you will work closely with our clinical research specialists, solid experience within medical device development and sustainability will also be considered an advantage.
As a person, you find it natural to lead by example, to take ownership with an including team spirit while effectively ensuring communication and alignment with many stakeholders across functions. Additionally, you make accurate judgements and decisions, and you feel a natural desire to drive continuous improvement in a challenging environment as we continue to grow.
Finally, you need to have excellent command of the English language, as this will be your main working language both verbally and in writing.
Application and deadline
If you are interested in the position, please apply as soon as possible. This job ad might be online until January 21, 2022, but once we have found the right candidate, it will no longer be online.
If you have any questions about the position or Ambu A/S, please contact Elsebeth Aagaard, telephone +45 7225 2000. Your application will be treated with confidentiality
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