Regulatory Compliance Manager

5 days ago


Sligo, Sligo, Ireland Gertek Project Management Full time

Job Summary:

The Quality Assurance Specialist will play a critical role in ensuring the quality of our products and services. This position requires a high degree of autonomy, excellent communication skills, and the ability to work effectively in a team environment.

Main Responsibilities:

  • Ensure products meet specifications and site activities follow good manufacturing practices (GMP) and regulatory requirements.
  • Work within the Quality Team to achieve quality goals and ensure all actions comply with GMP.
  • Coordinate and ensure compliance with assigned parts of the Quality System.
  • Participate in quality system audits.
  • Help investigate customer complaints and implement corrective/preventive actions (CAPA).
  • Manage the CAPA process: initiation, investigation, correction, and preventative actions.
  • Track and report on Quality System performance metrics.

Requirements:

  • Degree in Engineering, Science, Quality, or a related field.
  • Minimum 2 years of experience in the daily operation of a quality system in a highly regulated combination product/device manufacturing environment.
  • Minimum 2 years working knowledge of quality system regulations (ISO13485/ISO9000; CFR 21 Part 820) or specific elements like process validation, design controls, CAPA, auditing, etc.


  • Sligo, Sligo, Ireland Allergan Full time

    About the RoleWe are seeking an experienced Regulatory Compliance Manager to join our team. This individual will be responsible for ensuring compliance with regulatory requirements, developing and implementing quality systems and processes, and leading cross-functional teams to achieve business objectives.The ideal candidate will have a strong understanding...


  • Sligo, Sligo, Ireland Collins McNicholas Recruitment Full time

    Job SummaryWe are seeking a highly experienced QA Compliance Specialist to join our client's team. The successful candidate will be responsible for ensuring that all products manufactured meet regulatory requirements and company standards.About the RoleThe QA Compliance Specialist will work closely with the quality team to develop and implement effective...


  • Sligo, Sligo, Ireland Team Horizon Full time

    We are seeking a Regulatory Compliance Manager to oversee the day-to-day operation of our quality system in a highly regulated combination product/device manufacturing environment.Key Responsibilities:Developing and implementing strategies to ensure compliance with quality systems regulations (ISO/ISO; CFR 21 Part ) and individual elements within the...


  • Sligo, Sligo, Ireland Quanta Consultancy Services Ltd Full time

    Quanta Consultancy Services Ltd is a global pharmaceutical company with 50,000 employees worldwide. We are committed to scientific breakthroughs and changing people's lives through our research and development efforts.We are seeking a Regulatory Compliance Manager to join our team in Dublin, Ireland. This is a 12-month contract opportunity that requires a...


  • Sligo, Sligo, Ireland Gertek Project Management Full time

    A Career Opportunity as Regulatory Compliance Quality ManagerAs a Regulatory Compliance Quality Manager at GerTEK Project Management, you will play a critical role in ensuring our company meets its quality and compliance obligations.The responsibilities of this position include:Leading daily walkarounds of manufacturing areas.Driving continuous improvements...


  • Sligo, Sligo, Ireland Headcount Solutions Full time

    Job Description:    Key Responsibilities:    As a Regulatory Compliance Manager, you will play a critical role in ensuring that our products meet the highest standards of quality and regulatory compliance. Your main responsibilities will include:Coodinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant...


  • Sligo, Sligo, Ireland Headcount Solutions Full time

    Job OverviewHeadcount Solutions is seeking a Regulatory Compliance Engineer to support a positive developmental culture and ensure compliance with Quality policies.Key ResponsibilitiesDevelop and maintain Site Validation Master Plans and Project Validation Plans.Create validation protocols and final reports that meet cGMP standards.Manage validation,...


  • Sligo, Sligo, Ireland Allergan Full time

    **Quality Matters:**At AbbVie, we prioritize quality above all else. As a Quality Manager, you will play a critical role in ensuring compliance with quality standards and regulatory requirements.**Key Responsibilities:**Quality Assurance & Control: Oversee testing of raw materials, manufacturing quality control, and product validation.Team Leadership: Manage...


  • Sligo, Sligo, Ireland TN Ireland Full time

    TN Ireland is seeking a highly skilled Regulatory Compliance Expert to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and developing strategies to mitigate risks associated with medical devices.The role requires strong analytical skills, attention to detail, and excellent communication...


  • Sligo, Sligo, Ireland Headcount Solutions Full time

    We are seeking a Regulatory Compliance Specialist to join our team at Headcount Solutions. This role involves ensuring that our products comply with relevant regulations and industry standards.The successful candidate will be responsible for:Developing and implementing regulatory strategies, ensuring compliance with regulatory requirementsConducting audits...


  • Sligo, Sligo, Ireland Team Horizon Remote Work Freelance Full time

    Job OverviewTeam Horizon is seeking a skilled Validation Engineer to support our client's manufacturing facility in Sligo for a 12-month contract. The successful candidate will be responsible for ensuring the qualification of computerized systems in compliance with Data Integrity policies and regulatory requirements. This exciting opportunity involves...


  • Sligo, Sligo, Ireland Quanta Consultancy Services Ltd Full time

    About the Job:Quanta Consultancy Services Ltd is seeking a skilled Regulatory Compliance Expert to join our team. As a key member of our quality team, you will play a critical role in ensuring that our operations meet the highest standards of quality and regulatory compliance.Responsibilities:The successful candidate will be responsible for reviewing and...


  • Sligo, Sligo, Ireland TN Ireland Full time

    TN Ireland is currently recruiting for a Regulatory Compliance Coordinator to support our new product introductions. This is a great opportunity for someone looking to develop their skills in regulatory compliance and quality assurance.About the Job:Ensure that all new products meet applicable regulatory requirements and policies.Maintain the effectiveness...


  • Sligo, Sligo, Ireland Sterling Engineering Ltd - Ireland & Europe Full time

    Job Summary:Sterling Engineering Ltd - Ireland & Europe is currently recruiting for a Quality Engineer on a contract basis. The successful candidate will be responsible for ensuring product quality and regulatory compliance within the organization.Key responsibilities include developing and implementing quality systems, conducting audits and investigations,...


  • Sligo, Sligo, Ireland Sterling Engineering Ltd - Ireland & Europe Full time

    About the RoleWe are currently recruiting for a Quality Engineer on a contract basis for a Sligo based client. The Quality Engineer will be responsible for ensuring that products manufactured at the site comply with approved specifications and current good manufacturing practice (cGMP) and Regulatory Agency requirements.Key Responsibilities: Quality System...


  • Sligo, Sligo, Ireland TN Ireland Full time

    Job Title: Manufacturing Compliance SpecialistTN Ireland is seeking a highly skilled Regulatory Compliance Officer to join their team in Sligo, Ireland.About the Role:Ensure that all products leaving the site meet the required standards for marketed and investigational drug products.Provide quality and compliance oversight and assistance to the Operations...


  • Sligo, Sligo, Ireland TN Ireland Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at TN Ireland.ResponsibilitiesEnsure new products comply with applicable regulatory requirements and policies.Maintain the effectiveness of product integration into our quality system.Support new product transfers from development through to commercialization,...

  • Validation Engineer

    1 week ago


    Sligo, Sligo, Ireland Sigmar Recruitment Full time

    About Your Career as a Validation Engineer - Regulatory ComplianceAre you looking for a challenging opportunity where you can use your skills to make a difference? As a Validation Engineer - Regulatory Compliance, you will be joining a global biopharmaceutical company that focuses on developing and commercializing products contributing to oncology and eye...


  • Sligo, Sligo, Ireland PE Global Full time

    Role Summary:This is an exciting opportunity for a Quality Assurance Compliance Specialist to join our team in Sligo.Key Responsibilities:Ensuring that all products leaving site meet the required standards for marketed and investigational drug products.Providing quality and compliance oversight and assistance to the Operations function to manufacture...


  • Sligo, Sligo, Ireland Quanta Consultancy Services Ltd Full time

    About the Role:We are seeking a highly skilled Regulatory Compliance Expert to join our team at Quanta Consultancy Services Ltd.Company Overview:Our global pharmaceutical client is a world leader in research and development, with a commitment to discovering and developing new medicines that change people's lives.Job Description:Lead investigations into...