Regulatory Affairs Coordinator for Medical Laser
4 weeks ago
RegulatoryAffairs Coordinator for Medical Lasers Norlase is a high-growth, scale-up company developing the next generation of medical lasers for ophthalmology. We are an international team of laser technology and medical device experts, with offices in Ballerup and Silicon Valley. We have launched three revolutionary products, the LEAF, LION, and ECHO laser systems. All three are already in use in the world's top eye hospitals. We are currently looking into expanding our products’ reach, especially ECHO, as well as developing the next product for our portfolio. At Norlase... . . . . .. You are given a high level of autonomy and responsibility .. You are working with best-in-class experts, with a high level of drive and ambition .. You are part of a close-knit team, taking care of each other .. You are on a mission to fight preventable blindness through technological innovation - and have some fun along the way This position is a unique opportunity to gain broad experience within medical device regulatory affairs and quality assurance, in a successful scale-up company. Job Description We are looking to hire a Regulatory Affairs Coordinator to ensure country approvals for our devices worldwide. You will also support other functions within regulatory affairs and quality assurance. As Regulatory Affair Coordinator you will work closely with one of our US colleagues to coordinate country approvals and be the regulatory point of contact for assigned countries. Norlase has achieved market approval in Europe and US. In collaboration with our sales team and distributors, you will compile and send the requested documentation packages while some countries may have specific requests and you will be facilitating those responses in a close dialogue with our Norlase team. You will also coordinate the implementation of new or revised international standards, directives, and regulations for our medical devices. On a yearly basis, you will take care of our Post Market Surveillance/Product Safety Update Report program to ensure our devices are on par for state-of-the-art laser photocoagulations. You will also be involved in the regulatory approval process for new products. This includes supporting activities within Risk Management, Usability Engineering, Labelling, EU Technical File, FDA 510(K) etc. As time passes, you will preferably embrace new responsibilities within the area of Quality, depending on your interests and competencies. You will report directly to our VP of Regulatory Affairs and Quality Assurance, as part of our Quality team. Qualifications You have a deep interest in medical device regulatory affairs and/or quality assurance. You have preferably worked a few years within one of these fields. You must have oral and written fluency in English to communicate extensively with distributors and partners around the world, as well as with English-speaking colleagues at Norlase. It is an advantage if you have a driver’s license and car, as you will periodically need to visit various ministries and foreign embassies in Copenhagen. As a person, you must be well-structured and motivated by following good documentation practices. Finally, you are excited by the prospect of joining a small, close-knit team on a start-up journey. Drive and passion are more important than experience for this position. As part of our Quality team, it’s essential that you pursue pragmatic and balanced quality efforts at any given time. You will be seen as a cultural leader for good communication, documentation practice and behaviors in our medical device company. Application procedure Please send your CV and cover letter to Jan Forstberg, VP of Regulatory Affairs and Quality Assurance, at e-mail JFO@norlase.com. We will start the interview process immediately and will be conducting interviews on an ongoing basis until the right candidate is found.
-
Regulatory Affairs Coordinator for Medical Laser
1 month ago
Ballerup, Ballerup Kommune, Denmark Norlase Full timeRegulatoryAffairs Coordinator for Medical Lasers Norlase is a high-growth, scale-up company developing the next generation of medical lasers for ophthalmology. We are an international team of laser technology and medical device experts, with offices in Ballerup and Silicon Valley. We have launched three revolutionary products, the LEAF, LION, and ECHO laser...
-
Ballerup, Ballerup Kommune, Denmark Gn Hearing AS Full timeWould you like to step into position where you ensure a smooth and efficient market access, making a difference for our end users? At GN, we develop innovative hearing solutions with great sound quality and excellent design to ensure that hearing aid users will be able to hear more, do more, and be more. In the role as (Senior) Regulatory Product...
-
Ballerup, Denmark Gn Hearing AS Full timeWould you like to step into position where you ensure a smooth and efficient market access, making a difference for our end users? At GN, we develop innovative hearing solutions with great sound quality and excellent design to ensure that hearing aid users will be able to hear more, do more, and be more. In the role as (Senior) Regulatory Product...
-
Clinical Standards Developer Specialist
2 weeks ago
Ballerup, Denmark TN Denmark Remote Work Freelance Full timeYour role • Develop and maintain programming solutions, such as standard SAS macros, APIs, tools to support the analysis and reporting of clinical trial data across various trials and clinical development projects • Act as a superuser, providing day-to-day support to end-users of our Statistical Computing Environment and our analysis and reporting...
-
Principal Scientist
1 week ago
Ballerup, Ballerup Kommune, Denmark TN Denmark Full timeYour role As a Principal Scientist within Translational Sciences, your overall objective will be to characterize the potency and mode of action of new drug molecules, shaping indication and differentiation strategies within projects, as well as provide skin biology and immunology input to impact disease strategy and insourcing of new projects.More in detail,...
-
Global Process SME and Product Owner
1 week ago
Ballerup, Denmark LEO Pharma AS Full timeField of work: Supply Chain & ProcurementPosting Date: 7 May 2024Location: Ballerup 2750, Denmark, Denmark Contract type: Permanent Job ID: 2151Are you passionate about process optimization and finding best solutions? This is an opportunity to work in a central role that bridges IT and the business where you will drive optimization and streamlining processes...
-
Global Process SME and Product Owner
1 week ago
Ballerup, Ballerup Kommune, Denmark LEO Pharma AS Full timeField of work: Supply Chain & ProcurementPosting Date: 7 May 2024Location: Ballerup 2750, Denmark, Denmark Contract type: Permanent Job ID: 2151Are you passionate about process optimization and finding best solutions? This is an opportunity to work in a central role that bridges IT and the business where you will drive optimization and streamlining processes...
-
Clinical Standards Developer Specialist
1 month ago
Ballerup, Denmark LEO Pharma Full timeYour role • Develop and maintain programming solutions, such as standard SAS macros, APIs, tools to support the analysis and reporting of clinical trial data across various trials and clinical development projects • Act as a superuser, providing day-to-day support to end-users of our Statistical Computing Environment and our analysis and reporting...
-
Clinical Standards Developer Specialist
1 week ago
Ballerup, Ballerup Kommune, Denmark TN Denmark Full timeYour role Develop and maintain programming solutions, such as standard SAS macros, APIs, tools to support the analysis and reporting of clinical trial data across various trials and clinical development projects Act as a superuser, providing day-to-day support to end-users of our Statistical Computing Environment and our analysis and reporting standards ...
-
Product Owner, Anaesthesia, Global R&D
4 weeks ago
Ballerup, Denmark Ambu Full timeWould you like to manage full life-cycle activities for our Anaesthesia products? Do you carry experience from the MedTech industry, with understand of regulations and standards? Are you a natural cross-collaborator, who thrives in an international environment? Then this might be your defining moment. Apply today and join us for a career #ForeverForward! ...
-
AI Healthcare Data Specialist
2 days ago
Ballerup, Ballerup Kommune, Denmark Ambu AS Full timeDo you want to be part of bringing the cutting-edge application of Deep learning to the medical field? Do you want to be part of building a new market within endoscopy? Do you have experience in QA and clinical studies? Then this might be your defining moment. Apply today and join us in the exciting role as AI Healthcare Data Specialist Join us in shaping...
-
Experienced Analytical Scientist
1 week ago
Ballerup, Denmark Leo Pharma AS Full timeYour role You will play a crucial role in complex development projects, ensuring the timely delivery of high-quality scientific work. Collaborating closely with colleagues in drug substance and drug product development, you will define the strategy and direction for analytical development within Chemical Processes and Manufacturing, driving innovation and...
-
Experienced Analytical Scientist
3 weeks ago
Ballerup, Denmark LEO Pharma Full timeYour role You will play a crucial role in complex development projects, ensuring the timely delivery of high-quality scientific work. Collaborating closely with colleagues in drug substance and drug product development, you will define the strategy and direction for analytical development within Chemical Processes and Manufacturing, driving innovation and...
-
Global Process SME and Product Owner
1 week ago
Ballerup, Denmark LEO Pharma Full timeYour role will include gathering and prioritizing requirements from both business and authorities, leading the implementation of global technical requirements, and ensuring timely and high-quality changes to global processes in a GxP-environment. Your qualifications You will be collaborating closely with stakeholders across the value chain....
-
Ballerup, Denmark Psykiatrisk Center Ballerup Full timeDo you have excellent administrative skills? Do you want to support important research? We seek a unit administrator with the aim of providing high quality administrative support in the daily running of the Center for Research in Eating and feeding disorders (CEDaR). The position Your tasks will be varied and will include, but not be limited to: ...
-
Senior IC Test HW Engineer
1 month ago
Ballerup, Denmark GN Group Full timeDo you want to be part of test and verification for world-class low power audio chipsets? Then this is your chance to become part of a dedicated team, where you get to work together with colleagues, with expertise in every area of chipset design for hearing applications. Here you play a vital part taking charge of test and verification of the low power...
-
Test Automation Engineer
2 days ago
Ballerup, Denmark GN Group Full timeWould you like to work with development of software for cutting-edge automated test systems? Then this is your chance to become a vital part of a great and diverse team, where you can unfold your skills and your talent for collaboration in an international organization filled with great colleagues. If you are ready to unleash your potential in an...
-
Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS - A1p Full timeAre you passionate about driving experimental research activities in a pharma setting, and would you like to turn that into the discovery of new pioneering drug candidates? Then you may be our new colleague for us to welcome to the department of Rare Endocrine Disorders in Måløv, Denmark. Apply today to join our journey to create innovative drugs for Rare...
-
Senior IC Test HW Engineer
3 weeks ago
Ballerup, Denmark Jabra Full timeDo you want to be part of test and verification for world-class low power audio chipsets?Then this is your chance to become part of a dedicated team, where you get to work together with colleagues, with expertise in every area of chipset design for hearing applications. Here you play a vital part taking charge of test and verification of the low power...
-
Ballerup, Denmark Novo Nordisk Full timeKey Responsibilities : Drive end-to-end delivery and deployment of the OF4F solution to meet strong business demands across the Supply Chain organization Build and manage a team of highly skilled coworkers from various fields Lead and manage a steering group with consisting of directors/VPs, providing regular updates on project status, issues, and risks...