Clinical Compliance Specialist
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Ballerup
Are you passionate about 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.
You’ll be part of Global Clinical Compliance (GCC) team at Global Clinical Affairs (GCA), which is part of Global innovation organization at Ambu. In Global Innovation we have an ambitious innovation agenda and a high focus on supporting the products on the market. The GCC team is responsible for establishing, maintaining, and optimizing GCA processes related to compliance and literature management on a global level for all GCA sites. We are the “go-to” team during audits and inspections, and ensuring ongoing monitoring of standards and legislations applicable for GCA processes to ensure safe and efficient products on the market while maintaining continuous compliance with QMS- and regulatory requirements.
A global job as an expert and go-to person in clinical medical device requirements
As Clinical Compliance Specialist, you will plan and support clinical compliance activities across all GCA sites in connection with premarket and post market activities for our products worldwide.
The position is based at Ambu’s headquarter in Ballerup, Denmark and you will be reporting to the Team Manager for GCC at GCA.
As Clinical Compliance Specialist your responsibilities will include:
• Establish, maintain, and optimize processes at GCA in cross-functional collab with our stakeholders, and end users.
• Maintain and optimize processes for ongoing monitoring of standards and legislations related to GCA processes including performing gaps assessment, preparing action plan for implementation, along with executing implementation in GCA.
• Act as contact person for our stakeholders, and end users for topics related to GCA QMS documents ensuring continuous compliance with QMS- and regulatory requirements.
• Provide support in managing documentation in Ambu’s QMS and technical documentation for our products.
• Act as Subject Matter Expert for GCA during audits and inspections incl. collecting outcomes, preparing action plan, and sharing lessons learned.
• Set-up, maintain, and optimize scientific literature management processes while organizing and/or providing training to end users.
• Act as Admin for literature platforms and provide direct support in setting up and maintaining scientific literature surveillance ensuring a high level of literature retrieval data quality while maintaining an ongoing communication with our stakeholders, and end users.
• Mentor and train colleagues in gaining relevant knowledge in a learning environment.
Key competences
• A Master’s degree and experience within the fields of information science, library, quality assurance, regulatory affairs, clinical development, or similar degree in life science or med tech.
• Administrative and time management skills and experience with end-to-end compliance processes across the organization.
• Solid stakeholder managements skills and experience at all levels of the organization.
• Solid quality and analytical mind-set, process and result-oriented with eye for details.
• Experience as admin or super user in literature databases such as Embase and Pubmed or other literature or reference management digital platforms.
• Have a high integrity and ethical standards
• Flexible team player with a “can do” attitude
• Ability to drive continuous improvement in a challenging environment
International travelling should be expected as a part of the position (10-20 days per year) when possible.
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.
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 along with exciting job challenges and career opportunities contributing to your job satisfaction.
When to apply
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate.
For further inquiries please contact Team Manager, Global Clinical Compliance, Linda Matti, at +45 2217 4646.
Your application will be treated confidentially.
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.
You’ll be part of Global Clinical Compliance (GCC) team at Global Clinical Affairs (GCA), which is part of Global innovation organization at Ambu. In Global Innovation we have an ambitious innovation agenda and a high focus on supporting the products on the market. The GCC team is responsible for establishing, maintaining, and optimizing GCA processes related to compliance and literature management on a global level for all GCA sites. We are the “go-to” team during audits and inspections, and ensuring ongoing monitoring of standards and legislations applicable for GCA processes to ensure safe and efficient products on the market while maintaining continuous compliance with QMS- and regulatory requirements.
A global job as an expert and go-to person in clinical medical device requirements
As Clinical Compliance Specialist, you will plan and support clinical compliance activities across all GCA sites in connection with premarket and post market activities for our products worldwide.
The position is based at Ambu’s headquarter in Ballerup, Denmark and you will be reporting to the Team Manager for GCC at GCA.
As Clinical Compliance Specialist your responsibilities will include:
• Establish, maintain, and optimize processes at GCA in cross-functional collab with our stakeholders, and end users.
• Maintain and optimize processes for ongoing monitoring of standards and legislations related to GCA processes including performing gaps assessment, preparing action plan for implementation, along with executing implementation in GCA.
• Act as contact person for our stakeholders, and end users for topics related to GCA QMS documents ensuring continuous compliance with QMS- and regulatory requirements.
• Provide support in managing documentation in Ambu’s QMS and technical documentation for our products.
• Act as Subject Matter Expert for GCA during audits and inspections incl. collecting outcomes, preparing action plan, and sharing lessons learned.
• Set-up, maintain, and optimize scientific literature management processes while organizing and/or providing training to end users.
• Act as Admin for literature platforms and provide direct support in setting up and maintaining scientific literature surveillance ensuring a high level of literature retrieval data quality while maintaining an ongoing communication with our stakeholders, and end users.
• Mentor and train colleagues in gaining relevant knowledge in a learning environment.
Key competences
• A Master’s degree and experience within the fields of information science, library, quality assurance, regulatory affairs, clinical development, or similar degree in life science or med tech.
• Administrative and time management skills and experience with end-to-end compliance processes across the organization.
• Solid stakeholder managements skills and experience at all levels of the organization.
• Solid quality and analytical mind-set, process and result-oriented with eye for details.
• Experience as admin or super user in literature databases such as Embase and Pubmed or other literature or reference management digital platforms.
• Have a high integrity and ethical standards
• Flexible team player with a “can do” attitude
• Ability to drive continuous improvement in a challenging environment
International travelling should be expected as a part of the position (10-20 days per year) when possible.
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.
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 along with exciting job challenges and career opportunities contributing to your job satisfaction.
When to apply
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate.
For further inquiries please contact Team Manager, Global Clinical Compliance, Linda Matti, at +45 2217 4646.
Your application will be treated confidentially.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 10.2.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Ballerup
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