Compliance Specialist

3 days ago


Dublin, Dublin City, Ireland Sigmar Recruitment Full time

This range is provided by Sigmar Recruitment. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Direct message the job poster from Sigmar Recruitment

Executive Consultant: Quality & Regulatory - Pharma, Med Device & Biotech. Perm / Contract. (+353)1 474 4669

The Compliance Specialist will oversee regulatory compliance for medical products procured, stored, transported and sold by all companies, currently operating in Ireland, UK and Switzerland, but expected to extend to other EU countries in the future. They will also provide advice, research new legislation and business needs and control company registrations with regulators, including HPRA, MHRA, Swiss Medic, EMA and EuDAMED. The post holder will coordinate product compliance data collection and assessment, advising Head of Procurement of compliance (or non-compliance) of new medical devices and products. The postholder will coordinate the collection and calculation of data for Environment, Social and Governance reporting.

Job Responsibilities
  • Maintaining Product registrations in all territories for the
  • Acting as EUAR for Partners.
  • Acting as UKRP for Partners.
  • Maintaining EU and country importer licenses for medical devices.
  • Managing post market actions and NCA communications.
  • Advising the Management team on all aspects of Medical Device and IVD compliance.
  • Actively keep up to date with changes to regulations and highlight future changes impact on the business.
  • Conducting validation planning, testing and reporting to comply with 21CFR part 11, electronic records, on systems storing regulatory required records.
  • Coordinate Environmental, Social and Governance Reporting.
Qualifications / Experience
  • Educated to degree level or equivalent.
  • Interest in gaining a Regulatory Affairs Certificate (RAC) in medical devices (or equivalent), with support from company.
  • Good written and verbal communication skills.
  • Quality Management and inspection/auditing experience and ideally, certification as auditor.
  • 3-5 years' experience in the medical supply market.
  • Experience in medical device regulation, or quality management systems auditing.
Seniority level

Associate

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing and Medical Equipment Manufacturing

#J-18808-Ljbffr

  • Dublin, Dublin City, Ireland Elevate Partners Recruitment Limited Full time

    Elevate Partners Recruitment Limited is seeking a Risk and Compliance Specialist to join the Risk and Compliance team. This role will be fully on-site for the probation period.Key Responsibilities of the Risk and Compliance Specialist will include:Conduct data protection audits on a regular basis and ensure GDPR queries are answered.Ensure compliance with...


  • Dublin, Dublin City, Ireland Arista Networks Full time

    A skilled Legal Compliance Specialist is needed to join Arista's Legal Department.The specialist will support the management of due diligence processes, compliance records, and legal workflows.This role involves analyzing data, prioritizing tasks, and implementing improvements to the compliance program.The ideal candidate will have excellent organizational...


  • Dublin, Dublin City, Ireland Engage People Recruitment Full time

    Direct message the job poster from Engage People RecruitmentAward-winning financial services recruiter. Ex Corporate Banking Director with Deutsche Bank. Good craic.Compliance SpecialistEngage People Recruitment is delighted to partner with a global financial services firm with outstanding market recognition as an employer of choice in their field. Working...


  • Dublin, Dublin City, Ireland Construction Specialist Recruitment Full time

    Safety Specialist - Construction ExpertThe CSR Group is a leading construction contractor with over 30 years of experience delivering large-scale projects.Job Overview:Ensure compliance with health and safety regulations.Conduct thorough risk assessments and implement effective safety measures.We are seeking a motivated H&S Officer to take a lead role in...

  • Compliance Specialist

    4 weeks ago


    Dublin, Dublin City, Ireland Broadgate Full time

    Job description Compliance Specialist Fund Admin Hybrid WFH 65-80k This is a great opportunity for someone who is looking to take on some additional responsibility and grow in their career. Working as part of a small local compliance team, you will work very closely with the Head of Compliance across a wide range of compliance topics. ...


  • Dublin, Dublin City, Ireland Grifols, S.A Full time

    We are seeking a Regulatory Compliance Specialist to join our team at Grifols, S.A. This is an exciting opportunity to work in a dynamic and growing company that is committed to improving human health and well-being.The Regulatory Compliance Specialist will be responsible for ensuring all aspects of environmental compliance at the facility level. This...


  • Dublin, Dublin City, Ireland The Panel Group Full time

    Job Description:The Panel Group is seeking a highly skilled Compliance Specialist to support the development and implementation of compliance policies and procedures.Main Responsibilities:Support Data Privacy: Ensure compliance with GDPR and local country requirements, including administering the GDPR Tool (e.g. maintaining ROPAS, supporting business in...


  • Dublin, Dublin City, Ireland Bullfinch Recruitment Full time

    The Regulatory Compliance Specialist will play a pivotal role in maintaining our client's reputation as a trusted, compliant operator in the regulated gambling sector.We are seeking a compliance expert to lead the charge in ensuring our client's exceptional gaming experiences while upholding the highest standards of compliance and integrity.With a footprint...


  • Dublin, Dublin City, Ireland highr Full time

    About the Role:This is an exciting opportunity for a highly motivated and organized individual to join our team as a Regulatory Compliance Specialist. The successful candidate will be responsible for ensuring that our development projects meet all relevant regulatory requirements.You will work closely with our development team to ensure that all necessary...


  • Dublin, Dublin City, Ireland ACCA Careers Full time

    We are seeking a Compliance Specialist to join our FAAS department, providing expert advice to businesses across Ireland, The Isle of Man, Gibraltar, and Bermuda.The ideal candidate will have ACA/ACCA qualifications with 1-2 years' experience in a role demonstrating the required skills and attributes.A self-starter with excellent interpersonal and...


  • Dublin, Dublin City, Ireland Non-disclosed Full time

    Labor Law Compliance Specialist Job Description:We are seeking a highly skilled Labor Law Compliance Specialist to join our team in Dublin. As a Labor Law Compliance Specialist, you will be responsible for ensuring compliance with employment laws and regulations in Europe, the Middle East, and Africa.Key Responsibilities:Compliance: Ensure compliance with...


  • Dublin, Dublin City, Ireland Signatus Recruitment Full time

    About the OpportunityJohnson Hana is seeking to hire a Due Diligence/Compliance Specialist to join the Johnson Hana Community. This project will range from 6-12 months in length and there is a strong potential for the project to be extended beyond this timeframe.ResponsibilitiesConduct thorough due diligence and background checks to ensure candidates meet...


  • Dublin, Dublin City, Ireland Expeditors Full time

    **Job Overview**We are seeking a highly skilled Customs Compliance Specialist to join our team at Expeditors. As a key member of our customs brokerage department, you will play a crucial role in ensuring compliance with all relevant regulations and procedures.Key Responsibilities:Coordinate customs clearance documentation for our customer baseDeal with the...


  • Dublin, Dublin City, Ireland Meta Full time

    Data Compliance Specialist


  • Dublin, Dublin City, Ireland West Pharmaceutical Services Full time

    Job Summary : In this role the Quality Specialist, Compliance is responsible for maintaining the ongoing compliance of the Quality Management System. Quality Specialist, Compliance is responsible for the administration of the Document Management system on site including coordination of all document change request activities for their nominated area of...


  • Dublin, Dublin City, Ireland CS Recruitment Full time

    CS Recruitment is seeking a Company Compliance Specialist to join their team in Dublin.Job DescriptionProvide compliance support to the Capital Markets team, ensuring all activities are conducted in accordance with relevant laws and regulations.The successful candidate will have around three years' experience in compliance, with a strong understanding of...

  • Compliance Specialist

    11 hours ago


    Dublin, Dublin City, Ireland Sigmar Recruitment Full time

    The Compliance Specialist will oversee regulatory compliance for medical products procured, stored, transported and sold by all companies, currently operating in Ireland, UK and Switzerland, but expected to extend to other EU countries in the future. They will also provide advice, research new legislation and business needs and control company registrations...


  • Dublin, Dublin City, Ireland STEM Recruitment Partners Full time

    STEM Recruitment Partners is partnering with a leading pharmaceutical company in Dublin West to hire an EHS Specialist on a 12-month contract. This role offers a competitive hourly contractor rate.The EHS Specialist will work closely with the EHS Business Partner Manager to ensure health, safety, and environmental compliance at the site.Key responsibilities...


  • Dublin, Dublin City, Ireland Pinterest Full time

    Job DescriptionWe're looking for a highly skilled Regulatory Compliance Specialist to join our team. As a Regulatory Compliance Specialist, you will be responsible for developing and implementing a comprehensive operational regulatory compliance framework.This includes:Tracking, documenting, and understanding regulations that impact our businessIdentifying...


  • Dublin, Dublin City, Ireland Peninsula Full time

    At Peninsula, we are seeking a skilled Tax Compliance Specialist to join our team. This role is responsible for ensuring the company's global VAT compliance.Main Responsibilities:VAT reporting and planningEnsuring accurate and timely VAT filingsManaging large volumes of data for VAT returnsLiaising with in-house tax specialists and advisorsMaintaining VAT...