Principal Scientist – risk management for medical devices
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Ballerup
Do you want set the future standards for risk management within device development?
If you have solid experience within risk management related to development of injection devices, and you are looking for maximum impact and influence, we have just the right job for you. In LEO Pharma we have set the very ambitious goal to become the world’s preferred dermatology care partner. One of our strategic steppingstones is development of new, innovative medical devices. We have some years’ experience but now we need you to help us take the next important leap forward.
Risk management expert and spear head across projects and overall setup
Your objective is to contribute to the development of injectable treatments with user friendly and differentiated injection solutions based on thorough user and stakeholder understanding. As Principal Scientist you will act as spear head and set the future standards for Risk Management within the device area in LEO. You can look forward to being involved in exciting projects like development of needle free injection solutions (always in collaboration with external partners). Your primary tasks will be to:
• Act as risk management spear head and primary expert across device development projects
• Set the overall direction for risk management within device development in LEO
• Act as risk management specialist during audits
• Ensure uncompromised focus on risk management from a design, patient and manufacturing point of view
• Ensure compliance to relevant regulatory requirements
• Ensure internal documentation compliance
You will unfold your skills across production methods and technologies, assembly techniques, material selection, product functionality and testing of critical quality attributes. As you will join an organisation in transformation you must thrive in a world of on-going changes – and have the courage to prioritise and make business critical decisions when facing multiple opportunities.
Team worker with solid risk management experience
We are looking for a profile that really likes knowledge sharing and teamwork. Additionally, you must like to coach less experienced colleagues with the necessary patience and positivity. You will also need all of your communication skills including your ability to state clearly “Why, What and How”. As part of this you know how to interact with regulatory authorities (especially FDA). Your CV also comprises:
• A university degree in Engineering or related
• 8+ years’ experience within risk management related to development of medical devices
• Extensive knowledge of FDA and EMA requirements for injection devices
• Project management/coordination experience
Injection devices – your new team
You will join seven skilled colleagues in Injection Devices based at LEO Pharma’s HQ in Ballerup – with additionally min. five new colleagues to be hired primo 2020, you included. Our responsibility covers product solutions across medical devices, drug-device combination products and device constituent parts from early ideation to maintenance of marketed products.
The ambition is to grow as LEO Pharma is developing and expanding the presence in the injectable biologics area. We see the sky as the limit, and we are basically ready to go wherever our opportunities might take us.
If you have solid experience within risk management related to development of injection devices, and you are looking for maximum impact and influence, we have just the right job for you. In LEO Pharma we have set the very ambitious goal to become the world’s preferred dermatology care partner. One of our strategic steppingstones is development of new, innovative medical devices. We have some years’ experience but now we need you to help us take the next important leap forward.
Risk management expert and spear head across projects and overall setup
Your objective is to contribute to the development of injectable treatments with user friendly and differentiated injection solutions based on thorough user and stakeholder understanding. As Principal Scientist you will act as spear head and set the future standards for Risk Management within the device area in LEO. You can look forward to being involved in exciting projects like development of needle free injection solutions (always in collaboration with external partners). Your primary tasks will be to:
• Act as risk management spear head and primary expert across device development projects
• Set the overall direction for risk management within device development in LEO
• Act as risk management specialist during audits
• Ensure uncompromised focus on risk management from a design, patient and manufacturing point of view
• Ensure compliance to relevant regulatory requirements
• Ensure internal documentation compliance
You will unfold your skills across production methods and technologies, assembly techniques, material selection, product functionality and testing of critical quality attributes. As you will join an organisation in transformation you must thrive in a world of on-going changes – and have the courage to prioritise and make business critical decisions when facing multiple opportunities.
Team worker with solid risk management experience
We are looking for a profile that really likes knowledge sharing and teamwork. Additionally, you must like to coach less experienced colleagues with the necessary patience and positivity. You will also need all of your communication skills including your ability to state clearly “Why, What and How”. As part of this you know how to interact with regulatory authorities (especially FDA). Your CV also comprises:
• A university degree in Engineering or related
• 8+ years’ experience within risk management related to development of medical devices
• Extensive knowledge of FDA and EMA requirements for injection devices
• Project management/coordination experience
Injection devices – your new team
You will join seven skilled colleagues in Injection Devices based at LEO Pharma’s HQ in Ballerup – with additionally min. five new colleagues to be hired primo 2020, you included. Our responsibility covers product solutions across medical devices, drug-device combination products and device constituent parts from early ideation to maintenance of marketed products.
The ambition is to grow as LEO Pharma is developing and expanding the presence in the injectable biologics area. We see the sky as the limit, and we are basically ready to go wherever our opportunities might take us.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 13.1.2020, 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.
- Forsker
- Ballerup
- Mandag den 03. februar 2020
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