Medical Device Regulations Expert

3 weeks ago


Gloucester, Gloucestershire, United Kingdom Omega Full time
About the Role

We are looking for a highly skilled Regulatory Affairs Manager to join our team at Omega Resource Group.

The successful candidate will have extensive experience in regulatory affairs, with a strong background in medical devices and quality management systems.

As a key member of our team, you will be responsible for maintaining regulatory compliance and ensuring market access for medical devices internationally.

Responsibilities:

  • Maintaining up-to-date knowledge of domestic and international regulatory requirements.
  • Supporting the maintenance of the Quality Management System in accordance with relevant regulations.
  • Issuing advisory notices as required, adhering to MDD, MDR, and FDA regulatory requirements.
  • Developing high-quality technical files, design dossiers, and other necessary applications for regulatory submissions and approvals.

Requirements:

  • Proven experience in regulatory affairs, preferably in a managerial position.
  • Essential medical device experience, with Lead Auditor training and MDR experience desirable.

Estimated Salary: £70,000 - £90,000 per annum, depending on experience.



  • Gloucester, Gloucestershire, United Kingdom Omega Full time

    Job Summary:Regulatory Affairs Manager required to support our client in the medical device industry. This role involves ensuring compliance with regulations and maintaining market access for our products.Key Requirements:Proven experience in regulatory affairs, preferably in a managerial position.Essential experience in medical device regulations.Lead...


  • Gloucester, Gloucestershire, United Kingdom Expert Employment Full time

    Rugged Device Design ExpertExpert Employment is seeking an experienced rugged device design engineer to work on the development of electronic systems for harsh environments. The estimated salary range for this position is $160,000 - $220,000 per year. Responsibilities include designing and testing electronic systems to ensure they can operate in extreme...


  • Gloucester, Gloucestershire, United Kingdom Omega Full time

    Join Our Client's Team:We are seeking a highly skilled Regulatory Affairs Manager to join our client, a global leading manufacturer in the medical device industry. As a key member of the team, you will play a crucial role in ensuring business compliance, regulations, and quality standards.About the Role:Ensure business compliance with domestic and...


  • Gloucester, Gloucestershire, United Kingdom Redline Group Ltd Full time

    We are seeking a Medical Device Quality Control Expert to join our team at Redline Group Ltd in Gloucestershire, UK.The successful candidate will be responsible for ensuring the quality of our medical devices meets the highest standards.The key responsibilities of this role include:Conducting quality audits and inspections to ensure compliance with...


  • Gloucester, Gloucestershire, United Kingdom Redline Group Ltd Full time

    We are looking for a highly skilled Medical Device Quality Control Expert to join our team at Redline Group Ltd in Gloucestershire.This is an exciting opportunity to work with a leading Medical Device company and contribute to the development of high-quality products.The estimated salary for this position is £45,000 - £55,000 per annum, depending on...


  • Gloucester, Gloucestershire, United Kingdom Redline Group Ltd Full time

    Job DescriptionWe are seeking a Medical Device Manufacturing Expert to join our team at Redline Group Ltd in Gloucestershire. This is an exciting opportunity for a skilled professional to lead investigations into product quality and reliability.About the CompanyRedline Group Ltd is a leading Medical Device Manufacturer based in Gloucester. We are committed...

  • Compliance Manager

    6 days ago


    Gloucester, Gloucestershire, United Kingdom Omega Full time

    About the Role">This Regulatory Affairs Manager position requires an experienced professional to ensure business compliance with regulations and quality standards in support of the company's overall goal.">Key Responsibilities">">Maintaining accurate knowledge of both domestic and international regulatory requirements and effectively communicate this to...


  • Gloucester, Gloucestershire, United Kingdom Austin Fraser Full time

    Job Description: Medical Device Regulatory ManagerSalary Range: £55,000 - £75,000 per annumOverview:The successful candidate will be responsible for managing the implementation of a comprehensive Quality Management System in line with ISO 13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745, and ISO 14971.Key Responsibilities:Maintaining current...


  • Gloucester, Gloucestershire, United Kingdom Lifelancer Full time

    Medical Device Regulatory Lead Job Description:Salary: £55,000 - £70,000 per annumCompany Overview:Lifelancer, a renowned medical device manufacturer, is looking for a highly skilled Medical Device Regulatory Lead to oversee regulatory compliance and ensure the company meets its objectives.Job Description:Key Responsibilities:Maintain up-to-date knowledge...


  • Gloucester, Gloucestershire, United Kingdom Cpl Healthcare Full time

    Job SummaryCpl Healthcare is seeking a highly skilled Medical Device Design Consultant to join their team. This role offers a competitive salary of $100,000 - $130,000 per annum, depending on experience.Key Responsibilities:Support R&D laboratory and ensure equipment is adequately stocked and functioning correctly.Implement departmental objectives.Carry out...


  • Gloucester, Gloucestershire, United Kingdom Omega Full time

    We are seeking a highly skilled Medical Device Regulatory Specialist to join our team at Omega Resource Group. This role will involve ensuring regulatory compliance and maintaining market access for medical devices globally.Main Responsibilities:Maintain up-to-date knowledge on domestic and international regulatory requirements.Support the development and...


  • Gloucester, Gloucestershire, United Kingdom ZipRecruiter Full time

    At ZipRecruiter, we're seeking a talented Mechanical Design Engineer to join our team. As a key member of our product development team, you'll play a crucial role in designing and developing innovative medical devices.About the Role:We're looking for an experienced Mechanical Design Engineer who can create technical design documents, generate test protocols,...


  • Gloucester, Gloucestershire, United Kingdom ManpowerGroup Full time

    About the RoleWe are seeking a highly skilled and experienced Technical Support Engineer to join our team in Gloucestershire, UK. As a Technical Support Engineer - Medical Devices, you will be responsible for delivering high-quality technical support and services to our clients.You will have excellent communication skills, with the ability to effectively...


  • Gloucester, Gloucestershire, United Kingdom Lifelancer Full time

    About the RoleWe are seeking a seasoned Regulatory Affairs Manager to join our team in Gloucester, UK. As a key member of our organization, you will be responsible for ensuring business compliance with relevant legislation and quality standards.Our ideal candidate will have extensive experience in regulatory affairs, particularly in a managerial capacity,...


  • Gloucester, Gloucestershire, United Kingdom Triple West Medical Full time

    We are seeking a highly skilled Consultant in Acute Medicine to join our successful Medicine department at Triple West Medical. As a Consultant, you will be responsible for providing expert clinical care to patients and leading a team of medical professionals.About the Role:Key Responsibilities:Deliver high-quality patient care, working closely with our...


  • Gloucester, Gloucestershire, United Kingdom Cpl Healthcare Full time

    Join our talented team of engineers at Cpl Healthcare as a Mechanical Design Specialist - Medical Devices. As a Design Engineer, you will play a crucial role in supporting business needs through design development and product improvement activities.In this exciting role, you will be responsible for planning and coordinating your workload to brief provided,...


  • Gloucester, Gloucestershire, United Kingdom CV-Library Full time

    Join Our Team as a Certified Building Regulations ExpertWe are looking for a skilled and experienced individual to fill the position of Certified Building Regulations Expert.This role offers an exciting opportunity to work in a dynamic environment that values career development and work-life balance.Key Responsibilities:You will be responsible for inspecting...


  • Gloucester, Gloucestershire, United Kingdom Expert Employment Full time

    Job OverviewWe are seeking an experienced Electrical or Electronics Designer to join our team at Expert Employment. The successful candidate will be responsible for designing and developing electrical and electronic systems and components for complex electro-mechanical devices.This is a great opportunity for someone who wants to work on challenging projects...


  • Gloucester, Gloucestershire, United Kingdom Expert Employment Full time

    Job DescriptionThe Electrical or Electronics Designer is required to develop, implement and test components for complex electro-mechanical devices that operate in extreme environments.This role exists within a precision engineering environment where you will work as part of cross-functional teams on the full design life-cycle, including technical planning...


  • Gloucester, Gloucestershire, United Kingdom Expert Employment Full time

    Job DetailsThis Electrical or Electronics Designer role involves designing and developing electrical and electronic systems and components for complex electro-mechanical devices that operate in extreme environments.You will work as part of a cross-functional team on the full design life-cycle, including technical planning for system integration, test and...