Regulatory Compliance Specialist

4 days ago


Cork, Cork, Ireland Life Science Recruitment Full time

Life Science Recruitment is seeking a highly skilled Regulatory Compliance Specialist to join our client, a pioneering medical device company. This role is ideal for an individual with a strong background in regulatory affairs and a passion for ensuring compliance with medical device regulations.

About the Role

This Regulatory Compliance Specialist will be responsible for helping our client maintain a robust Quality Management System (QMS) that meets international regulatory standards. The successful candidate will work closely with the QA Manager to ensure that all regulatory requirements are met, including those related to CE marking and FDA submissions.

Key Responsibilities
  • Manage day-to-day regulatory activities, including handling multiple projects related to product and compliance enhancements.
  • Work closely with the QA Manager for notified body audits and other audits as required.
  • Assist in the migration from MDD to MDR within the organisation.
  • Support the wider team to ensure product manufacture and testing meet the requirements of both CE mark and FDA submissions.

Requirements

  • Bachelor's degree in engineering or science with a minimum of 4 years of experience in a medical device company.
  • Regulatory certifications in MDR desirable.
  • A minimum of 4 years of experience in the medical device industry.
  • Thorough understanding and knowledge of ISO 13485 and ISO 14971, MDD & MDR.

Why Join Our Client?

Our client offers a dynamic and entrepreneurial environment where you can make a real impact. As a Regulatory Compliance Specialist, you will have the opportunity to work on exciting projects, collaborate with a talented team, and contribute to the development of innovative medical devices.



  • Cork, Cork, Ireland Compliance & Risks Full time

    Job OverviewWe are seeking a highly skilled and experienced professional to join our team as a Global Compliance Specialist. This is an exciting opportunity for individuals who are passionate about compliance and risk management.About UsCompliance & Risks is a leading provider of regulatory compliance solutions, supporting businesses across diverse...


  • Cork, Cork, Ireland TN Ireland Full time

    TN Ireland is looking for a Regulatory Compliance Specialist to work within our QC Lab Services Team. The successful candidate will have a strong understanding of regulatory requirements and experience working within regulated industries.Key Responsibilities:Support the implementation of regulatory compliance initiatives.Monitor and report on compliance...


  • Cork, Cork, Ireland TN Ireland Full time

    Job OverviewTN Ireland is seeking a highly skilled Regulatory Compliance Specialist to join their team. This exciting opportunity will allow the successful candidate to utilize their expertise in regulatory compliance and risk management to drive business growth while ensuring adherence to relevant laws and regulations.Key ResponsibilitiesProvide strategic...


  • Cork, Cork, Ireland TN Ireland Full time

    We are seeking a skilled Regulatory Compliance Specialist to join our team at TN Ireland. The successful candidate will be responsible for supporting the maintenance of our Electronic Quality Management System and collaborating with the quality team to achieve key performance indicators (KPIs).The ideal candidate will have a systematic and thorough approach...


  • Cork, Cork, Ireland Life Science Recruitment Ltd Full time

    **Job Description**: We are seeking an experienced Regulatory Affairs professional to join our team in Cork, Ireland. As a Regulatory Compliance Specialist, you will be responsible for ensuring the company's medical devices comply with relevant regulations and standards.The ideal candidate will have a strong understanding of medical device regulatory...


  • Cork, Cork, Ireland Recruitment by Aphex Group Full time

    About the RoleThe Regulatory Compliance Specialist is responsible for ensuring that all aspects of our operations comply with relevant regulations and industry standards. This includes reviewing and implementing new procedures, conducting audits, and providing training to staff.


  • Cork, Cork, Ireland Recruitment by Aphex Group Full time

    Job OverviewWe are seeking a skilled Regulatory Compliance Specialist to join our team at Recruitment by Aphex Group.About the RoleThe primary function of this position is to ensure compliance with Good Manufacturing Practice (GMP) regulations and Company SOPs. This role will be responsible for reviewing and approving production and analytical documentation,...


  • Cork, Cork, Ireland TN Ireland Full time

    Quality Assurance RoleWe are seeking a highly skilled QC Specialist NPI to join our team in Ireland. As a key member of our quality assurance department, you will be responsible for ensuring the quality and integrity of new product introductions.Key Responsibilities:Quality Assurance: Ensure compliance with regulatory requirements, coordinate and plan...


  • Cork, Cork, Ireland Teleflex Full time

    About UsTeleflex is committed to improving the health and quality of people's lives through its medical technologies. As a global provider of innovative solutions, we aim to become the most trusted partner in healthcare. Our diverse portfolio includes products and services in various therapy areas, and we strive to empower the future of healthcare.Job...


  • Cork, Cork, Ireland Catalyx Full time

    About CatalyxWe're committed to attracting the best global talent and creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. Our team is dedicated to delivering world-class solutions that enhance efficiency and drive success.The QA Specialist RoleThis QA Specialist position plays a crucial role in ensuring the...


  • Cork, Cork, Ireland Enable Ireland Full time

    We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Enable Ireland. In this role, you will be responsible for ensuring compliance with all relevant regulations and legislation across our Services and Corporate Divisions.The successful candidate will have a relevant qualification in administration or a related field and a...


  • Cork, Cork, Ireland TN Ireland Full time

    Job SummaryQC Compliance Specialist RoleWe are seeking a highly skilled QC Compliance Specialist to join our team at TN Ireland. The successful candidate will be responsible for ensuring compliance with regulatory requirements and industry standards in our manufacturing environment.


  • Cork, Cork, Ireland Compliance & Risks Full time

    Compliance & Risks is the leading provider of market access and product compliance SaaS solutions. As a Sales Development Representative, you will be responsible for developing new business while growing your own career with Compliance & Risks.">">This is an exciting opportunity to join one of Ireland's fastest expanding SaaS companies, working with global...


  • Cork, Cork, Ireland Westbourne It Global Services Full time

    Welcome to Westbourne It Global Services:We're a leading global provider of innovative solutions, and we're looking for talented professionals like you to help us deliver exceptional results.About the Job:This exciting opportunity as a Qa Specialist offers the chance to work in a dynamic environment where collaboration, innovation, and quality excellence are...


  • Cork, Cork, Ireland TN Ireland Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team in Cork. As a member of our quality team, you will play a vital role in ensuring the quality of our products and services.Your primary responsibilities will include:Supporting quality systems, assisting with batch release process of drug product and pack label finished...


  • Cork, Cork, Ireland Pale Blue Dot®Recruitment Limited Full time

    About the Role:Pale Blue Dot Recruitment is seeking a seasoned Regulatory Compliance Specialist - Medical Devices to join our client's team. The successful candidate will be responsible for ensuring compliance with all regulatory requirements and developing effective regulatory strategies to support product development and submissions.The ideal candidate...


  • Cork, Cork, Ireland Life Science Recruitment Full time

    Company OverviewMy client, a leading medical device company, has developed a groundbreaking single-use product addressing pain points in surgical tympanostomy procedures. This innovative solution targets the most common procedure performed on children.About the RoleThis exciting opportunity involves ensuring compliance with regulatory requirements and...

  • Senior UX Designer

    7 days ago


    Cork, Cork, Ireland Compliance & Risks Full time

    **Our Vision**We envision a future where compliance is simplified through innovative technology and human-centered design. At Compliance & Risks, we strive to deliver cutting-edge solutions that enable our customers to achieve their goals while ensuring regulatory compliance.We are looking for an exceptional **Growth Design Director** who will spearhead the...


  • Cork, Cork, Ireland Life Science Recruitment Full time

    Company OverviewWe are a leading manufacturer and distributor of X-ray and MRI contrast media for internal and external customers worldwide.Our Pharmaceutical Diagnostics (PDx) business supports the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time.We employ approximately 600 staff at our...


  • Cork, Cork, Ireland Compliance & Risks Full time

    We are seeking a highly motivated Business Development Manager to join our team at Compliance & Risks. This is an exceptional opportunity to drive revenue growth and expand our presence in the market.As a Business Development Manager, you will be responsible for developing and executing business strategies that drive revenue growth and increase market...