Medical Device Compliance Manager

6 days ago


Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full time
About the Role:
The Clinical Affairs Specialist will be responsible for ensuring compliance with good clinical practice regulations and coordinating clinical trials. This role requires excellent communication and interpersonal skills, as well as experience in the medical device or pharmaceutical industry. The ideal candidate will have a strong understanding of clinical trial requirements and good clinical practice.

Key Responsibilities:
  • Ensure compliance with good clinical practice regulations.
  • Coordinate clinical trials from start to finish.
  • Prepare and submit clinical documents to ethics committees and regulatory authorities.
  • Liaise with external vendors and internal stakeholders.

Requirements:
To succeed in this role, you will need a degree in engineering or science discipline and minimum 2 years experience in the medical device or pharmaceutical industry. You should also have excellent writing skills and comprehension skills, as well as experience working in an SME environment. Regulatory experience is an advantage.

Skills and Qualifications:
This role requires a strong understanding of clinical trial requirements and good clinical practice. You should also have excellent communication and interpersonal skills, as well as experience working in an SME environment. A degree in engineering or science discipline and minimum 2 years experience in the medical device or pharmaceutical industry are also required.
  • Compliance Manager

    3 days ago


    Dublin, Dublin City, Ireland Sigmar Recruitment Full time

    About the RoleWe are seeking an experienced Regulatory Compliance Specialist to join our team. The successful candidate will be responsible for overseeing regulatory compliance for medical products procured, stored, transported, and sold by all companies operating in Ireland, UK, and Switzerland.Main AccountabilitiesOversee regulatory compliance for medical...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    About This RoleWe are seeking an experienced Senior Design Quality Engineer to join our client's team. In this role, you will be responsible for ensuring the design and development of medical devices meet the highest standards of quality, safety, and regulatory compliance.Responsibilities- Design control compliance: ensuring consistent, workable, and...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Job Description: We are currently recruiting for a Medical Device Manager to oversee the development and implementation of innovative medical devices. This role requires both technical expertise and a strong understanding of quality and regulatory standards within the medical device industry.Responsibilities: Develop and execute strategies to drive medical...


  • Dublin, Dublin City, Ireland GS Medical Full time

    About GS Medical LimitedWe provide comprehensive Medical Device Solutions to hospitals in Ireland and the UK. With facilities in Dublin and the UK, we offer expert knowledge, broad expertise, and flexible delivery options.The PositionWe are looking for a dedicated Junior Service Engineer to join our team.This field-based role requires performing validation,...


  • Dublin, Dublin City, Ireland Vectura Group Full time

    About Us:Vectura Group is a global leader in the development and delivery of inhaled medicines and medical devices. We are dedicated to innovation, quality, and compliance in delivering effective treatments for patients worldwide.Job Summary:We are seeking an experienced Manager - Regulatory Affairs and Medical Devices to contribute to our regulatory affairs...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    **Key Responsibilities**Oversee the implementation and operations of regulatory strategies for product registration submissions and progress reports.Interact with regulatory agencies to expedite approval of pending registrations.Serve as a regulatory liaison throughout the product lifecycle.Participate in product plan development and implementation,...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Life Science Recruitment is seeking an experienced Medical Device Project Lead to oversee and drive the success of strategic projects and initiatives within the medical device industry.The ideal candidate will have a strong understanding of medical device development processes, including design control, validation, and regulatory compliance. They will be...


  • Dublin, Dublin City, Ireland TN Ireland Full time

    This permanent hybrid role based in Dublin HQ offers a unique opportunity to join a young and exciting clinical-stage biotechnology company focused on discovering and developing novel therapies for debilitating diseases. As a Senior Director Regulatory Affairs Device, you will lead key elements of regulatory systems, ensuring compliance with relevant...


  • Dublin, Dublin City, Ireland Vectura Group Full time

    Job SummaryWe are seeking an experienced Regulatory Affairs Specialist to contribute to our regulatory activities, ensuring the successful and timely approval of relevant medical device submissions.This role will ensure global regulatory compliance while supporting Vectura's corporate goals. The successful candidate will provide strategic regulatory guidance...


  • Dublin, Dublin City, Ireland Hyper Recruitment Solutions Full time

    About the Role:We are currently looking for a highly skilled Senior QA Engineer for Medical Devices to join our client's team. The successful candidate will be responsible for ensuring the highest standards in device development and compliance.Key Responsibilities:Provide technical support and guidance for device development programs through the design and...


  • Dublin, Dublin City, Ireland TN Ireland Full time

    As a Senior Director Regulatory Affairs Device, you will be responsible for leading key elements of regulatory systems, ensuring compliance with relevant standards for medical devices including ISO 13485 and FDA QSR. This role involves defining the device regulatory strategy and overseeing all device submissions across global markets.Job Description:You will...


  • Dublin, Dublin City, Ireland Cpl Full time

    Key Skills and QualificationsA 3rd level qualification in a life science or pharmacy related discipline.Ideally, 3 years' work experience in a Medical Device/Pharmaceutical Industry, with knowledge of GDP and product complaints handling.Familiarity with relevant Legislation, Regulations, and Guidelines applicable in Ireland and the EU.Proficiency in English,...


  • Dublin, Dublin City, Ireland Emergent BioSolutions Full time

    We are seeking a highly experienced Design Assurance & Human Factors Engineering professional to join our team. As a Senior Engineer in this role, you will be responsible for ensuring the compliance of design control activities with international standards, regulations, and the company's QMS. This includes overseeing and managing the design history file,...


  • Dublin, Dublin City, Ireland Cpl Full time

    I am currently looking for a Territory Sales Manager who has experience selling medical devices into hospitals. This person will cover the greater Leinster Area, based out of Dublin. Looking for someone who has experience selling bespoke medical devices and who is passionate to excel in a sales role If this sounds like an opportunity that could be...


  • Dublin, Dublin City, Ireland embecta Full time

    We are embecta, a global diabetes care company committed to empowering people with diabetes through innovative solutions and partnerships.Develop and validate primary, secondary and tertiary packaging for diabetes care medical devices.Collaborate with cross-functional teams and outside suppliers to provide R&D project support.Work closely with team members...


  • Dublin, Dublin City, Ireland Vectura Group plc Full time

    Senior Manager Regulatory Affairs for Medical Devices and Person ResponsibleVectura Ireland Limited is seeking a Senior Manager in Regulatory Affairs for Medical Devices who will also assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Medical Device Design Control ExpertWe are seeking an experienced Senior Design Quality Engineer to join our client's team. As a key member of the quality organization, you will play a vital role in ensuring the design and development of medical devices meet the highest standards of quality, safety, and regulatory compliance.Responsibilities- Support new...


  • Dublin, Dublin City, Ireland TN Ireland Full time

    Sales Position OverviewWe are seeking a highly talented sales professional to join our team as a Medical Device Account Manager. The successful candidate will be responsible for promoting and selling the complete range of cardiovascular and endovascular solutions within a designated territory.The key responsibilities of this role include managing a portfolio...

  • Project Manager

    7 days ago


    Dublin, Dublin City, Ireland Cpl Full time

    About the RoleWe are seeking an experienced Senior Program Manager to oversee and drive the success of strategic projects and initiatives within the medical device industry.As a key member of our team, you will be responsible for managing cross-functional teams, ensuring alignment with business goals, and ensuring the successful delivery of innovative...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    About the Role:This is an excellent opportunity for a Senior Design Quality Engineer to join our client, a Medical Device organization based in Dublin. As a key member of the design team, you will be responsible for ensuring compliance with regulatory requirements and standards.Key Responsibilities:Support new product design and development, design transfer,...