Senior Regulatory Scientist

2 weeks ago

Dublin, Dublin City, Ireland Cook Medical Incorporated Full time
Overview

The primary role of the Senior Regulatory Scientist is to assist in the running of the regulatory affairs by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas.

Clinical & Post-Market Surveillance:

Responsibilities
  • Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
  • Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required and other jurisdictions as required.
  • Maintains an excellent understanding of the global medical device regulations.
  • Maintains a thorough understanding of the products assigned to the team.
  • Works to improve the function of the Regulatory Affairs Department.
  • Understands the progress of the RA team on assigned tasks, and removes roadblocks.
  • Provides support to the RA team members to complete assigned tasks.
  • Mentors and trains new RA team members.
  • Highlights any updates to regulatory requirements to regulatory management.
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
  • Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
  • Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
  • Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and updates same on approval status in target markets.
  • Ensures the clinical requirements of the product are adequately addressed.
  • Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements.
  • Communicates status of projects / submissions directly to RA Management and other stakeholders as required.
  • Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner.
  • Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
  • Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
  • Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
  • Provides support to currently marketed products as necessary including input on change requests, etc.
  • Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.
  • Is a delegate for the Senior Manager Post Market Surveillance, Regulatory Affairs / Manager, Regulatory Affairs, Principal Regulatory Scientist.
  • Is a delegate for the Regulatory Affairs Specialist.
  • Is a delegate for the Team Lead, Regulatory Affairs

Other General Responsibilities

  • Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
  • Perform additional duties as assigned.
Qualifications
  • Third level Qualification preferably in Science/Quality Engineering or Clinical (such as Pharmacy or Nursing)
  • 5 years' experience in a regulated industry in a similar role is desirable.
  • Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required.
  • Knowledge of requirements in other jurisdictions where required.
  • Knowledge of medical device quality standards/practises or similar regulated industry.
  • Good communication and inter-personal skills.
  • Proven problem-solving skills.
  • Good computer skills including knowledge of Microsoft
  • Proven organisational skills.
  • High self-motivation.
  • Willingness and availability to travel on company business

About Cook Limerick

Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets.

Regulatory in Limerick

Our RA team in Limerick are responsible for global regulation in over 60 countries, managing pre- & post- market regulation for all product classifications and novel devices across EMEA, AMER and APAC.

Working cross functionally with clinical, quality and engineering during the design process and throughout the device lifecycle, RA are involved in a broad range of activities including marketing authorization and submissions, vigilance and adverse event reporting and clinical evaluation. Our Regulatory Affairs team are central to holding Cook to the highest standards because everything we do has an impact on someone's life.

Our employee benefits include:

  • Hybrid Work Model
  • Company sponsored Defined Contribution pension scheme
  • Medical Health Insurance cover for you and your immediate family
  • Life Assurance and Income Protection cover
  • Educational Assistance
  • Performance related Bonus
  • Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
  • Fully equipped gym on site
  • 39-hour week with flexible start & finish times
  • Paid time off to participate in volunteer activities
  • Free parking
  • Subsidised restaurant
  • Sports & Social club

#LI-Hybrid

#J-18808-Ljbffr

  • Senior Safety Scientist

    1 month ago

    Dublin, Dublin City, Ireland Cpl Full time

    Drug Safety Scientist - Senior Manager - Hybrid/Remote The key focus of the Senior Safety Scientist role is on drug safety, evaluation, and risk-management. You will lead the safety scientists in developing signal detection practices and provide leadership for both the GDSP group and external departments regarding signal detection, signal evaluation and...

  • Senior Safety Scientist

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Drug Safety Scientist - Senior Manager - Hybrid/Remote The key focus of the Senior Safety Scientist role is on drug safety, evaluation, and risk-management. You will lead the safety scientists in developing signal detection practices and provide leadership for both the GDSP group and external departments regarding signal detection, signal evaluation and...

  • Senior Safety Scientist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Drug Safety Scientist - Senior Manager - Hybrid/Remote The key focus of the Senior Safety Scientist role is on drug safety, evaluation, and risk-management. You will lead the safety scientists in developing signal detection practices and provide leadership for both the GDSP group and external departments regarding signal detection, signal evaluation and...

  • Senior Medical Scientist

    2 months ago

    Dublin, Dublin City, Ireland Cpl Full time

    Medical Scientist, Senior (Haematology/Blood Transfusion)Cpl Healthcare in Partnership with the HSE is currently seeking a Senior Medical Scientist, Staff Grade (Haematology/Blood Transfusion) to join the team at St. Lukes Hospital, Pathology Laboratory, Dublin.6.A start date will be indicated at the job offer stagePurpose of the Post:In co-operation with...

  • Senior Medical Scientist

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Medical Scientist, Senior (Haematology/Blood Transfusion)Cpl Healthcare in Partnership with the HSE is currently seeking a Senior Medical Scientist, Staff Grade (Haematology/Blood Transfusion) to join the team at St. Lukes Hospital, Pathology Laboratory, Dublin.6.A start date will be indicated at the job offer stagePurpose of the Post:In co-operation with...

  • Senior Medical Scientist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Full time

    Medical Scientist, Senior (Haematology/Blood Transfusion)Cpl Healthcare in Partnership with the HSE is currently seeking a Senior Medical Scientist, Staff Grade (Haematology/Blood Transfusion) to join the team at St. Lukes Hospital, Pathology Laboratory, Dublin.6.A start date will be indicated at the job offer stagePurpose of the Post:In co-operation with...

  • Senior Medical Scientist

    2 weeks ago

    Dublin, Dublin City, Ireland Ttmhealthcare Full time

    Job Title: Senior Medical Scientist - HistologyLocation: Dublin, IrelandJob Type: PermanentJob DescriptionWe are seeking a skilled and experienced Senior Medical Scientist with expertise in Histology to join a busy service in South Dublin. The successful candidate will have a strong background in Histology and will be responsible for conducting a range of...

  • Senior Medical Scientist

    2 weeks ago

    Dublin, Dublin City, Ireland OASIS Group Full time

    Senior Medical Scientist / Biomedical ScientistDublin, IrelandPermanent, Part-timeWho We Are(CHI) is leading on the clinical and operational transformation of acute paediatric healthcare and consists of hospitals at Crumlin, Temple Street and Tallaght as well as an Urgent Care Centre at Connolly hospital in Blanchardstown.DescriptionSenior Medical Scientist...

  • Senior Scientist

    2 weeks ago

    Dublin, Dublin City, Ireland Horizon Quantum Computing Full time

    Senior Scientist - Quantum Networks and Secure DelegationWe are seeking an experienced senior scientist to help us develop capabilities towards secure quantum computing. Horizon staff have previously contributed to the development of many of the known secure delegation protocols and Horizon currently hosts a node on Singapore's national quantum...

  • Senior Scientist, Device

    2 weeks ago

    Dublin, Dublin City, Ireland Viatris Full time

    Senior Scientist, Device & Product Performance page is loaded Senior Scientist, Device & Product Performance Postuler locations Northern Cross, Dublin, Ireland time type Temps plein posted on Offre publiée hier job requisition id R McDermott Laboratories LimitedChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait...

  • Senior Scientist, Device

    2 weeks ago

    Dublin, Dublin City, Ireland Viatris Inc. Full time

    Senior Scientist, Device & Product Performance page is loaded Senior Scientist, Device & Product Performance Solicitar locations Northern Cross, Dublin, Ireland time type Tiempo completo posted on Publicado hace 2 días job requisition id R McDermott Laboratories LimitedEn VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos con...

  • Senior Safety Scientist

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Drug Safety Scientist - Senior Manager - Hybrid/Remote This role is responsible for providing expertise in implementing and maintaining a robust global pharmacovigilance (PV) compliance program within Global Drug Safety & Pharmacovigilance (GDSP) in close collaboration with Quality Assurance (QA). The Manager, PV Compliance will also support GDSP in internal...

  • Senior Medical Scientist Histology

    2 weeks ago

    Dublin, Dublin City, Ireland Eurofins Full time

    Job DescriptionWe are seeking a Senior Medical Scientist to join our team at Eurofins Pathology laboratory in Sandyford, Dublin. As an integral part of the department's team, you will need practical experience in Cellular Pathology and relevant histology knowledge. The ideal candidate will be an ambitious professional working in a Senior Medical Scientist...

  • Senior Medical Scientist Histology

    2 weeks ago

    Dublin, Dublin City, Ireland Eurofins Horti Full time

    Eurofins BiomnisIreland is the leading independent provider of Medical Laboratory Services in the country and part of one of the largest medical laboratory groups in the world. We are a medically led and ISO 15189 accredited organisation dedicated to delivering accurate and reliable medical laboratory results to help health care professionals diagnose, treat...

  • Medical Scientist

    2 weeks ago

    Dublin, Dublin City, Ireland Tallaght University Hospital Full time

    Job Title: Basic Grade Medical Scientist Reference No: Department / Directorate: Haematology Department / Laboratory Directorate Reports to: Chief Medical Scientist or Deputy Tallaght University Hospital (TUH) is an exciting and dynamic place to work. The team at the Hospital are in the midst of implementing a new hospital that has already...

  • Senior Data Scientist

    2 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    My client, a global company specialising in the development, manufacture and marketing of clinical diagnostic products are hiring aSenior Data Scientist to join their Biosensor Division in Bray Co. Wicklow.This is an exciting and innovative opportunity for an experienced candidate working with biosensors, the future of medical devices About the role ·This...

  • Senior Medical Scientist Clinical Chemistry

    2 weeks ago

    Dublin, Dublin City, Ireland Tallaght University Hospital Full time

    Job Title: Senior Medical Scientist Reference No: Department / Directorate: Clinical Chemistry, Laboratory Directorate Reports to: Chief Medical Scientist Tallaght University Hospital (TUH) is an exciting and dynamic place to work. The team at the Hospital are in the midst of implementing a new hospital that has already delivered on the opening of...

  • Senior Medical Scientist Clinical Chemistry

    2 weeks ago

    Dublin, Dublin City, Ireland What's On in Dublin Full time

    Senior Medical Scientist Clinical Chemistry permanent Posted 1 day ago This advertiser has chosen not to accept applicants from your region. Full Job DescriptionRecruitNet International Ltd specializes in relocating qualifiedprofessionals throughout Ireland and overseas, we guide you throughprofessional registration, job placement, visa, and employment...

  • Senior Process Scientist – Dublin Respiratory

    2 weeks ago

    Dublin, Dublin City, Ireland Viatris Inc. Full time

    Senior Process Scientist – Dublin Respiratory page is loaded Senior Process Scientist – Dublin Respiratory Solicitar locations Baldoyle, Dublin, Ireland time type Tiempo completo posted on Publicado ayer job requisition id R McDermott Laboratories LimitedEn VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos con valentía y...

  • Senior Medical Scientist

    2 weeks ago

    Dublin, Dublin City, Ireland RecruitNet Full time

    RecruitNet International Ltd specializes in relocating qualified professionals throughout Ireland and overseas, we guide you through professional registration, job placement, visa, and employment permit processing.We the RecruitNet team are always on call to help you find your perfect job and are staffed by highly experienced and professional nursing...