Current jobs related to QA Medical Device Senior Manager - Hellerup, Gentofte Kommune - Ascendis Pharma
-
QA Medical Device Senior Manager
1 month ago
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeAbout the RoleWe are seeking a highly skilled and experienced QA Medical Device Senior Manager to join our team at Ascendis Pharma. As a key member of our QA organization, you will play a crucial role in ensuring the quality and compliance of our medical devices and drug-device combination products.Key ResponsibilitiesDevelop and implement QMS improvement...
-
Senior Quality Assurance Manager Medical Devices
3 weeks ago
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeJob DescriptionAre you passionate about ensuring quality at every step and do you have a QA-mindset?Ascendis Pharma is seeking a talented Senior Quality Assurance Manager Medical Devices to join our team.About the RoleAs a Senior Quality Assurance Manager Medical Devices, you will play a crucial role in our Quality Assurance team, responsible for...
-
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeAscendis Pharma is a rapidly growing biopharmaceutical company with operations in multiple locations across the globe. Our mission is to develop innovative therapies that make a meaningful difference in patients' lives.We are seeking an experienced Senior Medical Device Quality Assurance Manager to join our team. This role will be responsible for ensuring...
-
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeAbout the RoleWe are seeking a highly experienced Senior Medical Director to lead our clinical development efforts in endocrinology and rare diseases. As a key member of our team, you will be responsible for driving the design, safety monitoring, and data analysis of our late-phase clinical trials studying TransCon C-type natriuretic peptide (CNP).Key...
-
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeAscendis Pharma is a biopharmaceutical company at the forefront of developing innovative therapies for rare endocrine and metabolic disorders.We are seeking a seasoned Senior Medical Director to drive our clinical development strategy, leveraging their expertise in designing and implementing late-phase clinical trials.This exciting opportunity offers a...
-
Senior Medical Director, Clinical Development
3 weeks ago
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeMedical Leadership OpportunityAscendis Pharma seeks a seasoned medical professional to drive the design, safety monitoring, and data analysis of clinical trials.We are a fast-growing biopharmaceutical company with a strong focus on developing innovative therapies for rare conditions. As a key member of our team, you will play a crucial role in shaping our...
-
Senior Project Manager with KYC Experience
3 weeks ago
Hellerup, Gentofte Kommune, Denmark emagine Consulting Full timeEmagine Consulting is looking for a Senior Project Manager with expertise in Know Your Customer (KYC) processes to lead projects in the financial sector.Key Responsibilities:• Approvals and assessment of risk on individual customers• Advising on high-risk customers and developing new structure and governance in the teamRequired Competencies:Knowledge and...
-
Senior Project Manager with KYC Expertise
1 week ago
Hellerup, Gentofte Kommune, Denmark emagine Consulting Full timeAt emagine Consulting, we're seeking a highly skilled Senior Project Manager to lead our KYC (Know Your Customer) initiatives. With a strong background in the financial sector, you'll oversee approvals, risk assessments, and develop governance structures for our clients.Job Responsibilities:Manage KYC case management systems, ensuring seamless integration...
-
Senior Sales Strategist
3 days ago
Hellerup, Gentofte Kommune, Denmark Boston Scientific Full timeBoston Scientific transforms lives through innovative medical solutions that improve the health of millions of patients worldwide.We're at the forefront of the medical device industry, leading and evolving it to address emerging needs in healthcare. Our culture powers our performance, and we turn our shared vision into value with the contribution of our...
-
National Key Account Manager
4 weeks ago
Hellerup, Gentofte Kommune, Denmark Boston Scientific Full timeBoston Scientific is a leading medical device company that transforms lives through innovative solutions.We're at the forefront of the medical device industry, leading and evolving it to address unmet and emerging needs in healthcare. Our culture powers our performance, and we turn our shared vision into value with the contribution of our colleagues around...
-
Associate Director of Medical Safety Science
4 weeks ago
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeMedical Safety Science LeaderAscendis Pharma is seeking a highly skilled Medical Safety Science Leader to join our team. As a key member of our Medical Safety Science team, you will be responsible for ensuring the safety of our products and providing leadership in the development of safety surveillance and risk management plans.Key Responsibilities:Lead the...
-
National Key Account Manager
3 weeks ago
Hellerup, Gentofte Kommune, Denmark Boston Scientific Full timeBoston Scientific transforms lives through innovative medical solutions that improve the health of more than 30 million patients worldwide each year.We're at the forefront of the medical device industry – leading and evolving it to address unmet and emerging needs in healthcare.National Key Account Manager - EndoscopyPurpose StatementDevelop and implement...
-
Senior Manager, Business Finance Corporate Lead
1 month ago
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeAbout the RoleWe are seeking a highly skilled Senior Manager, Business Finance Corporate to join our growing team at Ascendis Pharma. As a key member of the Business Finance team, you will play a crucial role in driving the evolution of financial reporting to management, quarterly corporate financial forecasting, and long-term financial planning.Key...
-
Senior Manager Competitive Intelligence
4 weeks ago
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeThe Competitive Intelligence department at Ascendis Pharma plays a vital role in maintaining a competitive edge in the industry. As a Senior Manager Competitive Intelligence, you will be responsible for leading competitive intelligence efforts, collecting and analyzing data to create a unified understanding of the market landscape.Key responsibilities...
-
Senior KYC Specialist
4 weeks ago
Hellerup, Gentofte Kommune, Denmark emagine Consulting Full timeEmagine Consulting is seeking a Senior KYC Specialist to join our team in Hellerup. The successful candidate will be responsible for approvals, risk assessments, and advising on high-risk customers.Key Responsibilities: Conduct thorough risk assessments on individual customers Develop and implement new structure and governance frameworks in the team Monitor...
-
Clinical Specialist
1 week ago
Hellerup, Gentofte Kommune, Denmark Boston Scientific Full timeUnlock Your Potential as a Clinical Specialist at Boston ScientificWe are seeking an experienced Clinical Specialist to join our team in Denmark. As a Field Clinical Specialist, you will provide clinical support to assigned accounts, working closely with customers to understand their needs and provide solutions that meet their requirements.About the RoleThis...
-
Hellerup, Gentofte Kommune, Denmark Bispebjerg og Frederiksberg hospital Full timeThe Bispebjerg og Frederiksberg hospital is seeking a highly skilled Senior Gastroenterologist and Hepatologist to fill the position of Clinical Professor. This role offers a unique opportunity to lead clinical research and teaching in collaboration with the University of Copenhagen.About the PositionWe are looking for a board-certified specialist in...
-
Clinical Electrophysiology Specialist
3 weeks ago
Hellerup, Gentofte Kommune, Denmark Boston Scientific Full timeAbout the RoleThe Field Clinical Specialist provides field/remote clinical, technical, and educational support to assigned accounts at a Territory, Regional, National, or EMEA level. The specialist works with the electrophysiology portfolio, covering Denmark, with some additional case support in neighboring regions as required by client needs. The primary...
-
Hellerup, Gentofte Kommune, Denmark Rigshospitalet - Blegdamsvej Full timeJob Title: Senior BiostatisticianWe are seeking a highly skilled Senior Biostatistician to join our team at Rigshospitalet - Blegdamsvej. As a Senior Biostatistician, you will play a key role in supporting clinical research studies in infectious diseases.About the RoleThe successful candidate will have a strong background in biostatistics and epidemiology,...
-
Senior Pharmacovigilance Compliance Manager
3 days ago
Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeJob OverviewWe are seeking a highly skilled Senior Pharmacovigilance Compliance Manager to join our team at Ascendis Pharma.
QA Medical Device Senior Manager
1 month ago
We are seeking a highly skilled QA Medical Device Senior Manager to join our team at Ascendis Pharma. As a member of our QA Medical Device team, you will play a crucial role in establishing relevant procedures for our activities and providing guidance and support to other functions to ensure we have an effective Quality Management System (QMS).
Key Responsibilities- Develop and implement QMS improvement activities to ensure compliance with regulatory requirements.
- Take a risk-based approach to quality management and justify decisions.
- Support medical device and drug-device combination product development projects, including design transfer and maintenance of technical documentation.
- Release medical devices and components, and handle deviations, CAPAs, and change control cases.
- Assist in the approval of new suppliers and participate in inspections and audits.
- Stay up-to-date on relevant regulatory requirements, including standards and guidelines.
To succeed in this role, you will need:
- A Master's degree in a natural science or a related field.
- A minimum of 5 years of QA experience in the life science industry.
- Experience with ISO 13485:2016, MDSAP, 21 CFR Part 820, 21 CFR Part 4, ISO 14971:2019, and ISO 11608:2022.
- Device development and design control experience.
- Supplier management and lead auditor experience.
- Knowledge of injection pens, autoinjectors, SaMD/SiMD, and connected health.
As a QA Medical Device Senior Manager at Ascendis Pharma, you will have the opportunity to work in a fast-paced environment, collaborate with cross-functional global teams, and contribute to the development of new and innovative therapies. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Travel: 5-10 days per year.
Office: Ascendis Pharma A/S, Tuborg Boulevard 12, Hellerup, Denmark.
