Medical Device Regulatory Expert

Unity Partners exclusively on behalf of our partner, AMT Medical We are actively seeking a Medical Device Design Engineer to join AMT Medical's innovative team. This innovative, minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without using a heart-lung machine, thereby reducing patient impact and speeding up...

Unity Partners exclusively on behalf of our partner, AMT Medical We are actively seeking a Medical Device Design Engineer to join AMT Medical's innovative team. AMT aims to transform Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. This innovative, minimally invasive technology enables surgeons to create a...

Professional Growth Opportunities:AMT Medical offers a unique opportunity for skilled professionals to grow their careers while making a significant impact on patient outcomes.About the Job:We are seeking a talented Medical Device Design Engineer to lead our innovation efforts. As a key member, you will design and develop Class III medical devices from...

The RoleWe are seeking a talented Medical Device Design Engineer to join our team at AMT Medical. As a key member of our engineering team, you will be responsible for designing and developing Class III medical devices from concept through to production scale-up.Key ResponsibilitiesDesign and develop Class III medical devices.Collaborate with cross-functional...

Unity Partners exclusively represents AMT Medical AMT Medical is a leading medical device company that is transforming the future of cardiac surgery with the Elana Anastomotic System. This cutting-edge technology allows surgeons to perform a sutureless bypass on a beating heart without the need for a heart-lung machine, resulting in improved patient...

Currently, I'm looking for a Senior RA Specialist to join a leading European Medical Device Manufacturer. As a member of the RA team, you will play a key role in ensuring the safety and effectiveness of their products, which are used by healthcare professionals across Europe. This Senior RA Specialist will oversee regulatory activities across two...

Unity Partners exclusively on behalf of our partner, AMT Medical AMT Medical is a Class III medical device company that is transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. Their minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without the use of a heart-lung...

Key ResponsibilitiesLead and coordinate human factors/usability engineering activities in collaboration with product development, quality, regulatory, manufacturing, and clinical teams.Develop use analysis in partnership with the risk management team.Create usability engineering documentation, e.g., Usability Engineering File (UEF), Use Specifications, Task...

Job Description:Work closely with Product Development teams to review Technical Documentation and provide feedback on compliance with relevant standards and regulations.Provide regulatory guidance to cross-functional teams to ensure understanding of Medical Device Regulations.Key Skills and Qualifications:Masters degree in health science or life science...

Unity Partners exclusively on behalf of our partner, AMT Medical AMT Medical is a Class III medical device company that is transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. Their minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without the use of a...

Unity Partners exclusively on behalf of our partner, AMT MedicalAMT Medical is a Class III medical device company that is transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. Their minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without the use of a heart-lung...

Currently, I'm looking for a Senior RA Specialist to join a leading European Medical Device Manufacturer. As a member of the RA team, you will play a key role in ensuring the safety and effectiveness of their products, which are used by healthcare professionals across Europe. About the Role: This Senior RA Specialist will oversee regulatory activities...

Ambitious Project:AMT Medical aims to transform Coronary Artery Bypass Surgery (CABG) with its pioneering Elana Anastomotic System. This revolutionary technology streamlines the procedure, reducing patient impact and speeding up recovery.Your Role:You will be responsible for designing and developing Class III medical devices from concept to production...

Unity Partners exclusively on behalf of our partner, AMT Medical AMT Medical is a Class III medical device company that is transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. Their minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without the use of a...

Unity Partners exclusively on behalf of our partner, AMT Medical AMT Medical is a Class III medical device company that is transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. Their minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without the use of a heart-lung...

We are seeking a talented Human Factors Specialist to join our team at AMT Medical. As a leading innovator in Coronary Artery Bypass Surgery, we are committed to reducing patient impact and shortening recovery times.The successful candidate will be responsible for leading human factors and usability engineering activities, working closely with engineering...

As a Product Development Lead for Implantable Devices at AMT Medical, you will play a critical role in shaping the future of cardiac care. Our mission is to transform Coronary Artery Bypass Surgery with our innovative Elana Anastomotic System.The successful candidate will be responsible for leading human factors and usability engineering activities, working...

The Role & Department Genmab continues to grow and is currently seeking a Medical Director to join our Medical Solid Tumor Team, focusing on early development/First-in-human trials.As Medical Director at Genmab, you will be accountable for the medical oversight of one or more clinical trials, medical review and communication of data, and medical input into...

Unity Partners exclusively on behalf of our partner, AMT Medical AMT Medical is a Class III medical device company that is transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. Their minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without the use of a heart-lung...

Vacature CSV Specialist (Medior/Senior/Subject Matter Expert) Heb jij uitgebreide kennis en ervaring op het gebied van softwarevalidatie in de medische hulpmiddelenindustrie? Wil je bedrijven ondersteunen bij het ontwikkelen van veilige, compliant en innovatieve medische software volgens de laatste wet- en regelgeving? Dan zijn wij op zoek naar jou Als CSV...