Medical Device QA Compliance Specialist
1 day ago
Innovate with Radiometer Danmark / Danaher to shape the future of diagnostics.
About UsAt Radiometer Danmark / Danaher, we bring together science and technology to accelerate real-life impact. We partner with customers across the globe to help them solve complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next in Life Sciences, Diagnostics, Biotechnology, and beyond.
Career OpportunityWe're seeking a Medical Device QA Compliance Specialist to join our team in Brønshøj, Denmark. As a key member of our Quality Management System (QMS) team, you'll be responsible for handling QMS processes and ensuring compliance within the organization.
This is an onsite role, and you'll be part of the RAQA organization. At Radiometer Danmark / Danaher, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. You'll report to the Senior Manager of QMS Compliance and work closely with cross-functional teams to drive quality excellence.
Key Responsibilities- Handle QMS and supporting processes to ensure compliance
- Share knowledge and maintain expertise within applicable standards and regulations
- Participate in and drive smaller projects in the RA/QA function with manageable risks and resource requirements
- Guide the organization during External Audits
- Plan, facilitate, conduct training of the organization
To succeed in this role, you'll need:
- MSc in Engineering, Pharmacy, Biology, Biochemistry, or similar
- Profound knowledge of and experience on best practices with Quality Management System(s) within Medical Devices/Diagnostics
- Min. 5 years of in-depth knowledge and experience with applicable standards and regulatory requirements (ISO 13485, IVDD/IVDR, MDR, and FDA legislation) from QA job function
- Excellent communication and stakeholder management skills
- Master spoken and written English and Danish language skills
The estimated salary for this position is around €60,000 - €80,000 per year, depending on experience. We also offer a comprehensive benefits package, including health insurance, pension plan, and opportunities for professional growth and development.
-
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark / Danaher, a leading company in the diagnostics industry, is seeking a skilled Dedicated QA Specialist to join our team. This exciting opportunity is based in Bronshoj, Denmark.The estimated salary for this position is approximately 73,000 - 92,000 DKK per annum, depending on qualifications and experience.About the RoleThis role will play...
-
Medical Device Quality Assurance Specialist
1 month ago
Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full timeCompany OverviewFerrosan Medical Devices A/S is a renowned international company specializing in the development and production of medical devices for surgical care. With a portfolio of products registered in over 100 countries, our organization collaborates with global medtech partners to bring innovative solutions to the market.About the RoleWe are seeking...
-
Copenhagen, Copenhagen, Denmark WSAudiology Full timeCompany OverviewWS Audiology is a market leader in the hearing aid industry, driven by a passion to improve quality of life.We are accelerating our business transformation to reach more people effectively.Job DescriptionAs a Global Senior Regulatory Affairs Specialist, you will ensure WSAudiology products meet the highest compliance standards.You will be...
-
Medical Device Quality Assurance Specialist
2 months ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeA challenging opportunity has arisen at Radiobotics for a highly motivated and experienced QA/RA specialist to join our Clinical and Regulatory team. This role will be responsible for defining and delivering on our strategy to maintain superior product quality and place our products in new markets.Main Responsibilities:Co-driving product release projects in...
-
Danish Speaking QA/QMS Compliance Specialist
2 months ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeIn an industry where patient care is paramount, Radiometer Danmark/Danaher relies on dedicated professionals to drive quality management systems forward. As a Danish speaking QA/QMS Compliance Specialist, you will play a pivotal role in ensuring the organization’s compliance with regulatory requirements.This onsite position, part of the RAQA organization...
-
Copenhagen, Copenhagen, Denmark WSAudiology Full timeWS Audiology is at the forefront of the medical device industry, navigating a rapidly evolving regulatory landscape.As a pivotal role in our company, we're seeking a Global Senior Regulatory Affairs Specialist to join our team.In this HQ-based position, you will be integral to ensuring that our products meet the highest standards of compliance.Your mission...
-
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeAbout the RoleWe are seeking a seasoned QA/RA specialist to join our Clinical and Regulatory team at Radiobotics. As a key member of our team, you will play a pivotal role in maintaining superior product quality and driving strategic growth through market expansion.The ideal candidate will have at least 1 year of experience within quality assurance and/or...
-
Medical Device Quality Assurance Specialist
2 months ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeAbout the JobWe are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team. As a key member of our Clinical and Regulatory department, you will be responsible for ensuring the quality and regulatory compliance of our medical devices.Your primary focus will be on defining and delivering our strategy to maintain superior product...
-
Medical Device Quality Assurance Specialist
3 weeks ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeCompany Overview:Radiobotics ApS is a company on a mission to solve the global need for radiologists while ensuring every patient receives expert-level care.We strive to learn what happens beyond the surface and show up every day, ready to engage and have fun with each other. This is us. We are Radiobotics.Salary:The estimated salary for this position is...
-
Medical Device Risk Specialist
2 months ago
Copenhagen, Copenhagen, Denmark 3Shape Full timeRisk Management Expert for Dental Scanning SystemsWe are seeking a highly skilled Risk Management professional to join our team and contribute to the development of scanner systems for the medical device domain. As a Risk Manager, you will play a crucial role in ensuring the safety and efficacy of our products.Your primary responsibility will be to work on...
-
Medical Device Training Specialist
1 month ago
Copenhagen, Copenhagen, Denmark Intuitive Full timeJob OverviewThis is an exciting opportunity to join Intuitive as a Medical Device Training Specialist. As a key member of our team, you will be responsible for delivering high-quality training programs for surgeons, physicians, and their care teams.
-
Senior Project Engineer
2 months ago
Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full timeBe Part of a Groundbreaking TeamFerrosan Medical Devices A/S is a pioneering company in the medical devices industry, and we're seeking a skilled Senior Project Engineer to join our team. As a key member of our Technology Innovation department, you'll play a crucial role in specifying next-generation manufacturing equipment for our out-sourced manufacturing...
-
Medical Device Quality Assurance Specialist
2 months ago
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeJob Description:Radiobotics Copenhagen is seeking a skilled Medical Device Quality Assurance Specialist to support our product development and regulatory affairs efforts. This is a part-time, temporary consultancy position to assist with our current needs.About the Role:We are looking for a detail-oriented and structured professional with at least 1 year of...
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeSeeking a meticulous QA Professional to spearhead Quality Oversight of outsourced development activities, ensuring compliance with regulatory requirements. About Ascendis Pharma A/S: We're a biopharmaceutical company leveraging our TransCon technology to pioneer new therapies addressing critical medical needs.We're currently hiring for a dedicated QA...
-
Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full timeAbout UsFerrosan Medical Devices A/S is an international company that develops and produces medical devices used in surgical care. Our portfolio consists of various hemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies.Job DescriptionWe are seeking a skilled Senior Project Engineer to...
-
Medical Device Regulatory Affairs Expert
1 month ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeJob Summary: We are seeking a highly skilled Medical Device Regulatory Affairs Specialist to join our team. As a key member of our Clinical and Regulatory team, you will play a critical role in maintaining superior product quality and ensuring compliance with regulatory requirements.About Us: At Radiobotics, we are driven by aspiration, curiosity, and...
-
Copenhagen, Copenhagen, Denmark Radiobotics ApS Full timeJob OverviewRadiobotics ApS is a dynamic company seeking a highly skilled medical device regulatory affairs specialist to join our Clinical and Regulatory team.
-
Quality Assurance Specialist
2 months ago
Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full timeAbout UsFerrosan Medical Devices A/S is an international company specializing in the development and production of medical devices for surgical care. Our portfolio includes hemostatic products and electromechanical devices for breast biopsies, registered in over 100 countries and marketed globally with medtech partners.Job SummaryWe are seeking a skilled...
-
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeRadiometer Danmark, a part of the global company Danaher, is seeking an Electronics Engineering Specialist to join our team in Brønshøj, Denmark. This temporary position offers a unique opportunity to contribute to the development and improvement of blood gas and immunoassay analyzers.As an Electronics Engineering Specialist at Radiometer Danmark, you will...
-
IT Compliance and Validation Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark ProductLife Group Full timeJob DescriptionWe are seeking a highly skilled IT Compliance and Validation Specialist to join our team at ProductLife Group.Company OverviewProductLife Group is a leading company in the Pharma IT sector, dedicated to providing innovative solutions for the pharmaceutical industry.SalaryThe estimated salary for this position is $80,000 - $110,000 per year,...