Regulatory Affairs Consultant for Medical Devices

Regulatory Affairs Document SpecialistWe are seeking a highly skilled Regulatory Affairs Document Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6,...

Radiobotics Copenhagen Freelance Part-time Salary Competitive This is a temporary consultancy position to support while we search for a permanent hire Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations...

Senior/Principal Medical Writing Consultants Pharma IT is hiring experienced Senior/Principal Medical Writer Consultants to join our Regulatory Affairs & Medical Writing Team In this role, you will work as a consultant to support our clients in the Pharma, Biotech and Medical Device industries. In this position, you will work on-site at the client's...

Radiometer Danmark/Danaher is a leading company in diagnostics, partnering with customers across the globe to help them solve their most complex challenges. We're looking for a highly skilled Regulatory Affairs Professional to join our team and contribute to our mission.The successful candidate will possess an MSc in Engineering, Pharmacy, Biology,...

About the JobWe are seeking a Medical Device Project Manager to join our Technology Innovation department. As a key member of our project team, you will be responsible for specifying next-generation manufacturing equipment for out-sourced manufacturing processes.Your primary focus will be on collaborating with external partners to prepare user requirement...

Job DescriptionWe are seeking a Senior/Principal Medical Writing Consultant to join our team. As a key member of our Regulatory Affairs & Medical Writing Team, you will work as a consultant to support our clients in the Pharma, Biotech, and Medical Device industries.In this role, you will be responsible for writing and reviewing clinical (and nonclinical)...

Clinical Documentation SpecialistWe are looking for a skilled Clinical Documentation Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6, integrated...

Job Description Summary LOCATION: Copenhagen, DenmarkROLE TYPE: Hybrid working (3 days per week in the office) As a member of the Regulatory Affairs (RA) team in Copenhagen, you will get the opportunity to work in a dynamic, agile team who has a common goal to bring our medicines to patients. We are looking for a Regulatory Affairs Manager or...

Medical Writing Expert ConsultantWe are seeking an experienced Medical Writing Expert Consultant to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will work as a consultant to support our clients in the pharmaceutical, biotechnology, and medical device industries. You will be responsible for writing and reviewing clinical...

Radiobotics Copenhagen Full-time Salary Competitive Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe...

Job DescriptionThe Senior Regulatory Affairs Specialist is responsible for ensuring regulatory compliance and securing approvals for new products, line extensions, and additional claims. They will manage the coordination and submission of regulatory applications for drugs, cosmetics, medical devices, and similar products.This role requires strong knowledge...

Radiobotics Copenhagen is seeking a highly skilled QA/RA specialist to join our Clinical and Regulatory team. As a key member of our team, you will play a central role in maintaining superior product quality and expanding our presence in new markets.This temporary consultancy position requires a seasoned QA/RA expert with a flair for product quality and...

Job SummaryThis role is an excellent opportunity for a seasoned Regulatory Affairs professional to lead regulatory projects both locally and globally. The ideal candidate will have a strong background in regulatory compliance, excellent communication skills, and the ability to work effectively in a fast-paced environment.The selected candidate will be...

**Job Overview**The ideal candidate will possess most of the following qualifications:M.Sc. degree or higher, preferably within biomedical or electrical engineeringExperience working with QA/QC for medical devicesExperience with mixed technology productsDocumented expertise in main standards governing medical device development and production, such as MDR,...

Key ResponsibilitiesThe Quality Compliance Officer will be responsible for:Ensuring compliance with regulatory requirements.Performing delegated duties concerning regional Wholesale Distribution licences.Maintaining Norgine's Nordics quality management systems.Supporting successful regulatory inspections.Generating regional metrics.Contributing to risk...

Achieve extraordinary results as a Senior Design Control Specialist in our Device Development team.At Ascendis Pharma A/S, we are dedicated to making a meaningful difference in patients' lives through the development of new and potentially best-in-class therapies. Our TransCon technology enables us to build a leading, fully integrated biopharmaceutical...

Company OverviewWe are a dynamic and globally oriented business that is expanding our organization around the product X1 CBCT unit. Our team is dedicated to bringing CBCT scanning to the next level by enabling true motion correction and high fidelity scanning to clinics across the world.We pride ourselves on providing an opportunity for the industry's best...

About UsC. H. Lundbeck A/S is a leading global pharmaceutical company that has been active in the production of drugs for more than 70 years. Our main goal is to develop and commercialize treatments for brain diseases. We are committed to delivering innovative treatments to patients around the world.Job DescriptionWe are seeking a highly skilled Senior...

Clinical Documents SpecialistWe are looking for a skilled Clinical Documents Specialist to join our Regulatory Affairs & Medical Writing Team at Pharma IT.In this role, you will be responsible for writing and reviewing clinical and nonclinical documents for regulatory submissions in the EU and US, including Module 2.5, 2.7, 2.4, 2.6, integrated summaries of...

About the RoleThe ideal candidate for this position holds at least 10 years of experience within drug development in the pharma/biotech industry, with at least 5 years of experience in medical writing. Understanding of international regulations, ICH guidelines, and document preparation and production (CTDs) is required.A strong understanding of clinical...