Find Senior medical Jobs in Limerick, Lk

Senior Regulatory Affairs Specialist
Cook Group —Limerick, County Limerick
- Full-time
- Organisational skills
- Computer skills
- Communication skills
4d
Senior Radiation Therapist - Limerick Cancer Centre
UPMC —Limerick, County Limerick
- €53,195.66–€69,136.16 a year
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Associate Fund Controller
GP Fund Solutions —Limerick, County Limerick
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Life insurance
Quick apply
Senior Software & Controls Engineer
AIR Shannon —Shannon, County Clare
- €55,000–€70,000 a year
- Full-time
- Project management
- Bachelor's degree
- No degree
Quick apply
8d
Manufacturing Engineer II
Edwards Lifesciences —Limerick, County Limerick
- Full-time
- Doctoral degree
- CAD
- Engineering
Senior .NET Desktop Developer
Analog Devices —Limerick, County Limerick
- Full-time
Mixed-Signal Design Engineer
Analog Devices —Limerick, County Limerick
- Full-time
- Master's degree
- Bachelor's degree
- Electrical Engineering
Mixed Signal Design Engineer
Analog Devices —Limerick, County Limerick
- Full-time
- Master's degree
- Bachelor's degree
- Electrical Engineering
Senior Project Manager
Lufthansa Technik Turbine Shannon —Shannon, County Clare
- From €80,000 a year
- Full-time
- Engineering
- English
- Analysis skills
- Work from home
- Employee assistance program
Quick apply
6d
Medical Scientist, Senior Pathology ICT IS Officer HSEMW22026 - Amended
Health Service Executive —Limerick, County Limerick
Senior Engineer, Quality Engineering
Analog Devices —Limerick, County Limerick
- Full-time
- Engineering
- Bachelor's degree
- Manufacturing
6d
Home Support Area Manager- Shannon (Clarecare)
Clarecare —Shannon, County Clare
- Weekend availability
- Microsoft Powerpoint
- Microsoft Outlook
- Microsoft Office
- Annual leave
- Employee assistance program
Quick apply
14d
Global Talent Development Program Leader (Fixed Term Contract)
Analog Devices —Limerick, County Limerick
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Project management
Senior Project Manager, Research and Development
Cook Group —Limerick, County Limerick
- Full-time
- Microsoft Powerpoint
- Engineering
- Project management
- Free parking
- Wellness program
Facilities Manager
Mowlam Healthcare —Limerick, County Limerick
- Hybrid work
- Engineering
- Project management
- Nursing
Quick apply
11d
Director, Manufacturing Systems
Cook Group —Limerick, County Limerick
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
4d
Director, Manufacturing Systems
Cook Group —Limerick, County Limerick
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
4d
Staff Systems Engineer
BD —Limerick, County Limerick
- €75,900–€115,725 a year
- Doctoral degree
- Engineering
- Master's degree
Senior Engineer, Product Applications
Analog Devices —Limerick, County Limerick
- Full-time
- Software troubleshooting
- Engineering
- System design
8d
Senior AI Product Manager
Datavant Ireland —Limerick, County Limerick
- Remote
- Analysis skills
- Product management
- AI
Quick apply

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Senior Regulatory Affairs Specialist

Cook Group -
Limerick, County Limerick

Apply Now

Job details

Full-time
4 days ago

Qualifications

Organisational skills
Computer skills
Communication skills

Full job description

Overview:

The primary role of the Senior Regulatory Affairs Specialist is to assist in the running of the Regulatory Affairs department 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.

Find out more about Cook Medical here

Responsibilities:

Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
Maintains an excellent understanding of the global medical device regulations.
Maintains a thorough understanding of the regions and/or 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.
Communicates country/region specific regulatory requirements of the regions they are assigned to the RA team
Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed and collaborates with their assigned regulatory specialists on same in any jurisdiction.
Ensures the clinical requirements of the product are adequately addressed.
Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that jurisdiction.
Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable).
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.
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/distribution partners/Cook affiliates 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.
Provides support to currently marketed products as necessary including input on change requests, regulatory restrictions
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 other Regulatory Affairs Specialists, Senior Regulatory Scientist and the Team Lead, Regulatory Affairs.
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
5 years’ experience in a regulated industry in a similar role is desirable.
Ideally have knowledge of requirements in MDSAP countries.
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.

#LI-AK1

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Refine Your Search

senior medical jobs in limerick, lk

Senior Regulatory Affairs Specialist

Senior Radiation Therapist - Limerick Cancer Centre

Associate Fund Controller

Senior Software & Controls Engineer

Manufacturing Engineer II

Senior .NET Desktop Developer

Mixed-Signal Design Engineer

Mixed Signal Design Engineer

Senior Project Manager

Medical Scientist, Senior Pathology ICT IS Officer HSEMW22026 - Amended

Senior Engineer, Quality Engineering

Home Support Area Manager- Shannon (Clarecare)

Global Talent Development Program Leader (Fixed Term Contract)

Senior Project Manager, Research and Development

Facilities Manager

Director, Manufacturing Systems

Director, Manufacturing Systems

Staff Systems Engineer

Senior Engineer, Product Applications

Senior AI Product Manager

I want to receive the latest job alerts for senior medical in limerick, lk

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