Talent.com
This job offer is not available in your country.
Quality / Regulatory Specialist

Quality / Regulatory Specialist

Mckesson’S CorporateCork, Ireland
7 days ago
Job description

Quality / Regulatory Specialist page is loaded## Quality / Regulatory Specialistremote type : Hybridlocations : Corktime type : Full timeposted on : Posted Todayjob requisition id : JR0135674McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare.

We are known for delivering insights, products, and services that make quality care more accessible and affordable.

Here, we focus on the health, happiness, and well-being of you and those we serve – we care.What you do at McKesson matters.

We foster a culture where you can grow, make an impact, and are empowered to bring new ideas.

Together, we thrive as we shape the future of health for patients, our communities, and our people.

If you want to be part of tomorrow's health today, we want to hear from you.

  • Position Summary
  • Reporting to the
  • Director of Quality
  • , the
  • Quality and Regulatory Specialist
  • is responsible for reviewing product qualification documentation to ensure compliance for McKesson private label products and customer-branded products across international markets.

This role supports regulatory alignment, documentation accuracy, and complaint handling.

  • Key Responsibilities
  • Product Qualification & Documentation Review
  • Review and maintain product qualification documents for private label products distributed internationally.
  • Ensure documentation aligns with applicable U.S. FDA regulations (excluding submission responsibilities) and other international regulatory requirements.
  • Coordinate with suppliers and contract manufacturers to obtain and verify technical documentation, declarations of conformity, and product specifications.
  • Maintain organized records of product approvals and compliance evidence for internal and customer use.
  • Customer Complaint Handling
  • Receive, assess, and process product complaints from international customers.
  • Request additional information to fully understand reported events.
  • Evaluate complaints for potential regulatory impact and escalate as needed.
  • Support timely and accurate reporting in accordance with applicable international regulations.
  • General QA / RA Support
  • Maintain working knowledge of U.S. FDA regulations and international standards relevant to medical devices, cosmetics, and dietary supplements.
  • Support continuous improvement of quality and regulatory processes, including updates to SOPs and QMS documentation.
  • Participate in internal and external audits as required.
  • Additional Responsibilities
  • The above statements describe the general nature and level of work being performed.
  • Additional responsibilities may be assigned as required.

  • Experience Required
  • Minimum 4 years' experience in Quality Assurance and / or Regulatory Affairs within the Medical Device or Pharmaceutical industry.
  • Familiarity with FDA regulations, ISO 13485 : 2016, ISO 14971, and ISO 10993 series.
  • Knowledge of regulations for cosmetics and dietary supplements is a plus.

  • Education
  • Bachelor's degree in science or engineering.
  • Specialized Knowledge / Skills
  • Strong written and oral communication skills.
  • Technical writing proficiency.
  • High learning aptitude and adaptability with software systems.
  • Project management capabilities.
  • Ability to work effectively in dynamic environments.
  • Strong analytical and problem-solving skills.
  • Customer-focused mindset aligned with organizational priorities.
  • Excellent attention to detail and planning ability.
  • Cultural awareness and sensitivity.
  • PC / Equipment
  • Proficient in MS Office (Word, Excel, SharePoint, PowerPoint).
  • Work Environment / Physical Demands
  • General office environment.
  • Limited travel, both regional and international, may be required.At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people.
  • That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being.

    Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves.As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson.

    This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets.

    The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations.

    In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

  • Our Base Pay Range for this position
  • €49,800 - €83,000
  • #J-18808-Ljbffr

    Create a job alert for this search

    Specialist • Cork, Ireland

    Related jobs
    • Promoted
    Quality Technician

    Quality Technician

    SanminaCork, Munster, Republic of Ireland
    JOB TITLE : Quality Technician DEPARTMENT : Quality Department REPORTING TO : Quality Operations Lead About Sanmina Fermoy Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO for ...Show moreLast updated: 30+ days ago
    • Promoted
    Health & Safety Manager

    Health & Safety Manager

    ABP IrelandTipperary, Munster, Republic of Ireland
    At ABP we aim to hire the brightest and the best.People who are aligned with our values and are passionate about our industry. We are committed to developing our people, whether it be upskilling our...Show moreLast updated: 30+ days ago
    • Promoted
    Instrumentation & Controls Engineer - Tipperary

    Instrumentation & Controls Engineer - Tipperary

    PM GroupTipperary, Munster, Republic of Ireland
    Overview PM Group is a leading International Engineering, architecture, project and construction management firm.With a network of offices in Europe, Asia and the US and a multi-discipline team of ...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Systems Specialist

    Quality Systems Specialist

    LGC LimitedTipperary, Munster, Republic of Ireland
    Job Description What you'll be doing You'll lead and support a broad range of quality systems activities, including : Implementing, maintaining, and improving our Quality Management System (QMS) Mai...Show moreLast updated: 20 days ago
    • Promoted
    Quality Inspection Specialist

    Quality Inspection Specialist

    Collins McNicholasCork, Munster, Republic of Ireland
    An exciting opportunity for an experienced Quality Inspection Specialist to join our client, a leading packaging and labelling manufacturer on an initial 6-month contract (great scope for extension...Show moreLast updated: 23 days ago
    • Promoted
    Senior QA Specialist

    Senior QA Specialist

    Headcount SolutionsTipperary, Munster, Republic of Ireland
    Senior QA Specialist As a Senior QA Specialist, you will be a key driver of quality assurance activities on the site of a leading Tipperary based Pharmaceutical multinational, ensuring that all ope...Show moreLast updated: 27 days ago
    • Promoted
    Payroll & HR Administrator

    Payroll & HR Administrator

    FRS RecruitmentTipperary, Munster, Republic of Ireland
    Our client based close to Cashel are currently recruiting for a Payroll & HR Administrator.This is a great role which includes working closely with the Payroll Manager and also within The HR functi...Show moreLast updated: 27 days ago
    • Promoted
    Quality Engineer

    Quality Engineer

    Morgan McKinleyTipperary, Munster, Republic of Ireland
    We are seeking Manufacturing / Quality Engineers to support a large-scale remediation initiative within the medical device industry. This contract role offers the opportunity to work directly on produ...Show moreLast updated: 7 days ago
    • Promoted
    Research and Development Manager

    Research and Development Manager

    Morgan McKinleyTipperary, Munster, Republic of Ireland
    The R&D Manager is responsible for leading research and development activities and collaborating with cross-functional teams to drive innovation. The role ensures alignment with company goals, focus...Show moreLast updated: 29 days ago
    • Promoted
    Senior Mechanical Engineer - Site-Based - Tipperary

    Senior Mechanical Engineer - Site-Based - Tipperary

    PM GroupTipperary, Munster, Republic of Ireland
    Overview PM Group is a leading International engineering, architecture, project and construction management firm.With a network of offices in Europe, Asia and the US and a multi-discipline team of ...Show moreLast updated: 30+ days ago
    • Promoted
    HSQE Site Officer

    HSQE Site Officer

    EPS GroupTipperary, Munster, Republic of Ireland
    About the Role : We are seeking an HSQE Officer to oversee the HSQE requirements on the construction of a new wastewater treatment plant in North Tipperary. The HSQE Officer is responsible for ensuri...Show moreLast updated: 30+ days ago
    • Promoted
    Manufacturing Technician

    Manufacturing Technician

    FRS RecruitmentTipperary, Munster, Republic of Ireland
    Manufacturing Technician - Thurles / Templemore My client has just launched a brand-new yeast production plant near Thurles / Templemore, transforming a dairy by-product into a sustainable, non-GMO a...Show moreLast updated: 23 days ago
    • Promoted
    Quality systems specialist

    Quality systems specialist

    WhatJobsTipperary, Tipperary, Ireland
    Job Description What you'll be doing You'll lead and support a broad range of quality systems activities, including : Implementing, maintaining, and improving our Quality Management System (QMS) Mai...Show moreLast updated: 13 days ago
    • Promoted
    HR Generalist

    HR Generalist

    Robert Walters LimitedTipperary, Munster, Munster
    Our client is a forward-thinking organisation that has experienced extensive growth in the past two years.Due to continue growth and investment, they are growing their HR team! If you are a HR Gene...Show moreLast updated: 9 days ago
    • Promoted
    Deltav technical lead (11m, tipperary, hybrid)

    Deltav technical lead (11m, tipperary, hybrid)

    WhatJobsTipperary, Tipperary, Ireland
    DELTAV TECHNICAL LEAD required by Career Wise Recruitment for our multinational Pharmaceutical client in Co.Tipperary, 3 days on site (Tuesday, Wednesday and Thursday) mandatory required.Initial 11...Show moreLast updated: 13 days ago
    • Promoted
    QA Specialist

    QA Specialist

    Claran Consultants LtdCork, Munster, Republic of Ireland
    Position Brand Description : The API EM Quality Assurance Specialist provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Specialist position is essential ...Show moreLast updated: 7 days ago
    • Promoted
    Construction Technical Bid Writer

    Construction Technical Bid Writer

    Ward PersonnelTipperary, Munster, Republic of Ireland
    Role Overview As a Technical Bid Writer, you will play a critical role in securing high-value construction contracts by producing compelling, technically accurate bid submissions.You will collabora...Show moreLast updated: 23 hours ago
    • Promoted
    Senior Automation and Digital Systems Lead

    Senior Automation and Digital Systems Lead

    Tandem Project Management LimitedTipperary, Munster, Republic of Ireland
    Summary : Our client, a pharmaceutical company in Co.Tipperary, is seeking a Senior Automation & Digital Systems Lead.The ideal candidate will be responsible for managing, coordinating, and supporti...Show moreLast updated: 1 day ago