Senior Regulatory Affairs Professional
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Senior Regulatory Affairs Professional, Displaying Units
Can you provide regulatory direction for development projects for new displaying unit instruments/Monitors used in connection with Ambu Endoscopes to support the fastest to market strategy? Are you looking for independence in your job, variance and a working day characterized by exciting new challenges? Would you like to be part of a great team in Ambu’s Corporate RA department and ensure that we meet regulatory requirements related to for instance software in an agile way? Then Ambu might be your next career move.
Our purpose is ‘together, we rethink solutions to save life and improve patient care’
Our aspiration is to be the most customer-centric company in our field and to expand our leading position within single use endoscopy solutions. Our four strategic focus areas are: Providing innovative solutions for true customer needs, to excel in execution across the value chain, take leaps towards a sustainable future, bring people together in one shared culture. In addition, Ambu is one of the first companies to be fully compliant with the EU Medical Device Regulation (MDR).
To be able to meet the increasing regulatory requirements on time, Ambu is looking for a skilled candidate to join the Corporate Regulatory Affairs department within our RA Innovation team for Displaying Units/Monitors.
You will be part of a highly skilled team of 7, and you will report to Head of Regulatory Affairs, Displaying Units, Gitte Juel Friis.
Executing efficiently
As part of an organization with short lines of decision-making, you will have a unique opportunity to influence the development of new products being a RA partner in development projects in a company where quality is of great importance. Here you will be responsible for implementing regulatory strategies and providing regulatory input for our displaying units /monitors containing software.
As Senior Regulatory Affairs Professional your responsibilities will include:
• Ensuring Regulatory Strategy and RA contribution for development of new displaying unit platforms to support a continuous fastest market access
• Provide RA direction and give input outside own team in Corporate RA and the organization as needed
• Participate in development projects and contribute to regulatory compliance in these projects as regulatory partner
• Create various documents for registration of products (e.g., EU CE mark, FDA, Canada and Japan and ensure STED documentation
• Create country submissions and drive answering of questions from authorities to ensure fast answers and approvals
• Evaluate regulatory impact of changes in relevant countries and ensure compliance
• Strengthening of Ambu's knowledge of regulatory requirements, to ensure that Ambu's products and processes comply to relevant regulatory requirements. This includes:
o Continuous improvement of Ambu QMS system within own area of responsibility, to ensure efficient and best practice procedures and processes
o Ensuring knowledge on regulatory requirements for technologies such as software and artificial intelligence and related requirements such as cybersecurity
o Ensuring regulatory input to Market Expansion Strategy as relevant for fastest to market access of new displaying unit platforms, including entrance into new countries, and to continued market access, according to Ambu Strategy
o Participation in Audits within own area of responsibility
Being part of cross functional teams, you will be working closely together with stakeholders from QA-Engineering, R&D, Marketing, Clinical Department, and other departments to develop our new products. Maintenance of Displaying Units on the market when doing changes is also part of the team’s responsibilities.
Key competences
You hold a master’s degree in engineering or other relevant education, and you have experience working with software in a regulated industry, preferably the medical device industry. Knowledge of relevant legislation and standards such as EN 62304 Medical device software – Software life-cycle processes and EN 60601 Medical electrical equipment will be an advantage. In addition, knowledge of regulation for Cybersecurity and country legislation for US and EU for instruments will be preferred.
To succeed in the job, you have a strategic mindset, are proactive and a team player. Furthermore, you must hold good communication skills and be able to challenge stakeholders when needed. You can give RA Guidance and RA Strategic direction in the organization, and you act as a role model and mentor for RA colleagues.
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.
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, Head of RA Displaying Units, Gitte Juel Friis, at +45 53651124
Your application will be treated confidentially.
Can you provide regulatory direction for development projects for new displaying unit instruments/Monitors used in connection with Ambu Endoscopes to support the fastest to market strategy? Are you looking for independence in your job, variance and a working day characterized by exciting new challenges? Would you like to be part of a great team in Ambu’s Corporate RA department and ensure that we meet regulatory requirements related to for instance software in an agile way? Then Ambu might be your next career move.
Our purpose is ‘together, we rethink solutions to save life and improve patient care’
Our aspiration is to be the most customer-centric company in our field and to expand our leading position within single use endoscopy solutions. Our four strategic focus areas are: Providing innovative solutions for true customer needs, to excel in execution across the value chain, take leaps towards a sustainable future, bring people together in one shared culture. In addition, Ambu is one of the first companies to be fully compliant with the EU Medical Device Regulation (MDR).
To be able to meet the increasing regulatory requirements on time, Ambu is looking for a skilled candidate to join the Corporate Regulatory Affairs department within our RA Innovation team for Displaying Units/Monitors.
You will be part of a highly skilled team of 7, and you will report to Head of Regulatory Affairs, Displaying Units, Gitte Juel Friis.
Executing efficiently
As part of an organization with short lines of decision-making, you will have a unique opportunity to influence the development of new products being a RA partner in development projects in a company where quality is of great importance. Here you will be responsible for implementing regulatory strategies and providing regulatory input for our displaying units /monitors containing software.
As Senior Regulatory Affairs Professional your responsibilities will include:
• Ensuring Regulatory Strategy and RA contribution for development of new displaying unit platforms to support a continuous fastest market access
• Provide RA direction and give input outside own team in Corporate RA and the organization as needed
• Participate in development projects and contribute to regulatory compliance in these projects as regulatory partner
• Create various documents for registration of products (e.g., EU CE mark, FDA, Canada and Japan and ensure STED documentation
• Create country submissions and drive answering of questions from authorities to ensure fast answers and approvals
• Evaluate regulatory impact of changes in relevant countries and ensure compliance
• Strengthening of Ambu's knowledge of regulatory requirements, to ensure that Ambu's products and processes comply to relevant regulatory requirements. This includes:
o Continuous improvement of Ambu QMS system within own area of responsibility, to ensure efficient and best practice procedures and processes
o Ensuring knowledge on regulatory requirements for technologies such as software and artificial intelligence and related requirements such as cybersecurity
o Ensuring regulatory input to Market Expansion Strategy as relevant for fastest to market access of new displaying unit platforms, including entrance into new countries, and to continued market access, according to Ambu Strategy
o Participation in Audits within own area of responsibility
Being part of cross functional teams, you will be working closely together with stakeholders from QA-Engineering, R&D, Marketing, Clinical Department, and other departments to develop our new products. Maintenance of Displaying Units on the market when doing changes is also part of the team’s responsibilities.
Key competences
You hold a master’s degree in engineering or other relevant education, and you have experience working with software in a regulated industry, preferably the medical device industry. Knowledge of relevant legislation and standards such as EN 62304 Medical device software – Software life-cycle processes and EN 60601 Medical electrical equipment will be an advantage. In addition, knowledge of regulation for Cybersecurity and country legislation for US and EU for instruments will be preferred.
To succeed in the job, you have a strategic mindset, are proactive and a team player. Furthermore, you must hold good communication skills and be able to challenge stakeholders when needed. You can give RA Guidance and RA Strategic direction in the organization, and you act as a role model and mentor for RA colleagues.
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.
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, Head of RA Displaying Units, Gitte Juel Friis, at +45 53651124
Your application will be treated confidentially.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 14.12.2022, 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.
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