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Regulatory Affairs Specialist

RandoxAntrim, Antrim

Regulatory Affairs Specialist – (Job Ref: 25N/REGS) Randox Laboratories continues to develop disruptive innovations within the Diagnostics and Healthcare sector globally. We are proud to have been named the Number 1 company in Northern Ireland, for the second consecutive year in the “Belfast Telegraph Top 100 Companies 2024”. Our staff are at the heart of everything we do and achieve. We have an exciting career opportunity for a Regulatory Affairs Specialist within our regulatory affairs team. Location : Randox Science Park, 30 Randalstown Rd, Antrim, BT41 4FL. Contract Offered : Full-time, Permanent. Working Hours / Shifts : 40 hours over four days per week: Monday to Thursday, 8am to 6.40pm. What does this role involve? The main function of this role is to provide regulatory support to ensure compliance with all relevant regulations. The main duties of the role include:  • Review websites on a regular basis to monitor updates to regulations and standards and to ensure any new relevant publications are purchased and reviewed. • Review new / updated publications and summarise impact to the company. • Present new publications to the Impact Assessment Team, take minutes of the Impact Assessment meeting and track actions from the meeting. • Ensure regulatory procedures comply with all applicable regulatory regulations and harmonised standards. • Advise teams of updates to regulations and advise them what is required. • Maintain the library of regulations and standards. • Assist with the preparation and update of regulatory assessments for new devices. • Work with relevant departments to maintain the life-cycle of documents for Randox Products. • Perform detailed format reviews of the technical files to ensure consistency. • Perform annual reviews of technical files and medical device files. • Review and approval of product labelling (IFU, labels).  • Provide regulatory support for customers, distributors and OEM partners. • Work with the QA & Regulatory teams to ensure regulatory compliance and licenses are maintained. Who can apply? Essential criteria: • Educated to degree level in a Science or Engineering related discipline, or relevant experience.  • Strong IT skills, including the use of Microsoft Office packages.  • Experience with interpretation of technical information and performance data. Desirable: • Experience in a controlled manufacturing or analytical environment.  • Experience of working in a highly regulated industry e.g. ISO13485, IVDR 2017/746, or similar standards. • Experience in preparing technical files. • Experience in registering IVD products and CDx products in US, Europe, China and Japan. • Knowledge of In vitro diagnostics (IVD) devices This advert may be open for as long as 30 days although we may close the advert early if we receive sufficient applicants to fill the roles.

2 days agoFull-timePermanent

Product Registration Officer

RandoxAntrim, Antrim

Product Registration Officer – (Job Ref: 25N/PRDR) Randox Laboratories continues to develop disruptive innovations within the Diagnostics and Healthcare sector globally. We are proud to have been named the Number 1 company in Northern Ireland, for the second consecutive year in the “Belfast Telegraph Top 100 Companies 2024”. Our staff are at the heart of everything we do and achieve. We have an exciting career opportunity for a Product Registration Officer within our regulatory affairs team. Location : Randox Science Park, 30 Randalstown Rd, Antrim, BT41 4FL. Contract Offered : Full-time, Permanent. Working Hours / Shifts : 40 hours over four days per week: Monday to Thursday, 8am to 6.40pm. What does this role involve? The main function of this role is to assist with national and international product registrations for Randox products. The main duties of the role include:  • Assist with all requirements of registering the Randox product line directly in Europe, Brazil, Canada, China, Saudi Arabia, Australia, Malaysia, South Korea and USA etc. • Prepare regulatory documentation, review and interpret previous regulatory documents, technical information and performance data to ensure compliance with national/ international regulations and standards. • Compile, submit and follow up on registration files to obtain and maintain marketing authorisations for IVD Medical Devices and to manage them throughout the life-cycle and respond to questions from the various regulatory authorities. • Support the Technical writers with updating technical files.  • Assisting with the IVDR CE marking process. • Provide regulatory support when required and ensure that customers, distributor and OEM partners are serviced at the highest level of satisfaction through quality service and quick responses. • Coordinate the legalisation of registration documents. • Prepare regulatory assessments for new products and assess the impact of changes on current registration. • Perform detailed format reviews of the technical files to ensure consistency. • Review and approval of product labelling (IFU, labels).  • Provide regulatory support for customers, distributors and OEM partners. • Work with the QA & Regulatory teams to ensure regulatory compliance and licenses are maintained. Who can apply? Essential criteria: • Educated to degree level in a Science or Engineering related discipline, or relevant experience.  • Strong IT skills, including the use of Microsoft Office packages.  • Experience with interpretation of technical information and performance data. Desirable: • Experience in a controlled manufacturing or analytical environment.  • Experience of working in a highly regulated industry e.g. ISO13485, IVDR 2017/746, or similar standards. • Experience in preparing technical files. • Experience in registering IVD products and CDx products in US, Europe, China and Japan. • Knowledge of In vitro diagnostics (IVD) devices This advert may be open for as long as 30 days although we may close the advert early if we receive sufficient applicants to fill the roles.

2 days agoFull-timePermanent

Chef

Mount CharlesBelfast, Antrim£13.25

Would you like to be part of a team that believes people are our greatest asset? Our family values speak for themselves: Do the right thing, Have fun & grow together, Take pride in what you do!  We are currently recruiting for a Chef to join our team based at Adelaide House, Belfast. This is a great opportunity to join a world leading facilities management company.  Working Pattern: Please note, the successful applicant's offer is subject to the Access NI (Enhanced) check prior to commencement of role. The Access NI Code of Practice is available upon request. Mount Charles Group has a policy on recruiting ex-offenders, a copy of which can be provided upon request. Having a criminal record will not necessarily prevent you from working for the Mount Charles Group. The Mount Charles Group is an equal opportunities employer and welcomes applications from all sections of the community. Due to the number of applicants Mount Charles receives, we only respond to short-listed applicants. If you have not been contacted within six weeks of the closing date, you have not been selected for interview. GREAT PEOPLE - GREAT SERVICE - GREAT FUTURE

2 days ago

Cleaning Operative

Mount CharlesDown£12.21

If you are a customer focused individual and want to join a fun and family orientated food and facilities management company which believes people are our greatest asset, then we have a role for you! Our family values speak for themselves:  Do the right thing, Have fun & grow together, Take pride in what you do! We are currently recruiting for Cleaning Operatives to join our team covering Translink in Portadown. This is a great opportunity to join a world leading facilities management company. Working Pattern: The Mount Charles Group is an equal opportunities employer and welcomes applications from all sections of the community.  ​​Due to the number of applicants Mount Charles receives, we only respond to short-listed applicants. If you have not been contacted within six weeks of the closing date, you have not been selected for interview.  The successful candidate's job offer will be subject to passing a Personal Track Safety Medical Assessment. This will include a full and thorough medical, (including a drug and alcohol test) for the purpose of Public Train Safety prior to appointment. GREAT PEOPLE - GREAT SERVICE - GREAT FUTURE

2 days agoPart-time

Production Operator

KilwaughterLarne, Antrim

Job Title: Production Operative Location: Kilwaughter, Larne ​​​​​​​ This is a fantastic opportunity to join our team and work as part of a growing business that is prepared to invest in your future. We currently have an opportunity for a Production Operative to join our Operations team. As part of our production team you will have the responsibility of operating production machinery to produce a range of products.

2 days ago

Dispenser/trainee Dispenser

Clear PharmacyBallyclare, Antrim

We have an excellent opportunity for a qualified Part Time Dispenser/Trainee Dispenser to work in our Ballyclare branch. Working 20 hours per week, between the hours of 2.00pm to 6.00pm Monday to Friday. Additional hours may be required from time to time. Working as part of a team duties can include; sales of over the counter medicines, providing customers with information on symptoms and products, prescription receipt and collection, date checking, and the ordering, receiving and storing of pharmaceutical stock. Applicants must have excellent communication skills and have the ability to work accurately with attention to detail. Essential Criteria Hold NPA Accredited Assistants course or equivalent NVQ Level II in Pharmacy Services Previous relevant dispensary experience Flexible to work according to the rota Team worker Excellent customer service skills Must be prepared to complete further training within the pharmacy

2 days agoPart-timeTrainee

Duty Manager

Armagh City, Banbridge & Craigavon Borough CouncilDromore Community Centre, Banbridge, Armagh£37,035 - £38,626 per year

JOB PURPOSE: Committing to the one-team ethos, you will be flexible and collaborative and you will actively support all colleagues and other activities necessary to deliver the service objectives. As a Duty Manager, you will be responsible for leading the team in the delivery of an excellent customer experience. You will engage positively with staff and customers, understanding and meeting their needs as appropriate. You are responsible for the day-to-day operation and performance of a dry site(s), the management of the teams and the implementation of the agreed Service Plan. MAIN DUTIES AND RESPONSIBILITIES: 1. Manage the site(s) ensuring the adequate resourcing and efficient use of staff and resources in operating, developing and promoting the facilities, including staff rotas. 2. Recruit, lead and develop staff to ensure that they and any employees for which they are responsible: • Effectively manage their teams, positively contributing to wellbeing and high levels of employee engagement; • Implement and review appropriate training and development programmes for employees to ensure sufficient skills, capacity and knowledge within the service. • Operate within Council policies and procedures; • Deliver services in the most efficient and equitable manner and in accordance with Council governance and financial regulations; • Efficiently and effectively manage available resources; • Deliver their agreed performance targets; • Work in a corporate and collaborative way with other services and departments. 3. Responsible for organising and delivering induction training for new staff. 4. Responsible for organising and facilitating work placements and other employability programs. 5. Manage staff to ensure a continuous improvement culture. 6. Assist with the development of and implement the agreed Service Plans and SLA’s. 7. Be responsible for the management of the business unit ensuring it is managed to a high standard. Monitor and review performance against agreed performance targets. 8. Be responsible for updating and implementing all Normal Operating Procedures and Operating Standards, Emergency Action Plans, Technical Operating Procedures (equipment and plant operating instructions) and health and safety systems (risk assessments, etc.) are compliant with Council policy and regulatory standards and that checks and records are in place. 9. Ensure that all equipment, plant and operational procedures are operating safely, manage failures/breakdowns and take all necessary actions. 10. Implement health & safety and safeguarding systems within the site(s). 11. Ensure staff adhere to all cash-handling and reconciliation procedures. Liaising with audit and finance to ensure best practice. 12. Liaise with contractors whilst on site. 13. Operate as a key holder, opening and closing the facility, ensuring that the building is safe to use for customers on opening, and secure on closing. Respond to emergency call outs as necessary. 14. Work with management team to implement the cultural change necessary to ensure the Centre’s success. 15. Liaise with customers, deal with any appropriate incidents, accidents, complaints or queries and escalate as appropriate. 16. Actively participate in marketing/sales plans to maximise usage and income. 17. Promote and/or sell all products and activities within the site(s) and within the Leisure Services portfolio. 18. Be flexible and collaborative and actively support all colleagues and other activities or processes, which impact on the performance of the Centre. Qualifications and training • Third level qualification in a relevant discipline. Applicants who do not possess a relevant 3rd level qualification must demonstrate five years’ relevant experience as below Experience • Two years’ experience of supervising a team of staff to include each of the following: ▪ Identifying and resolving service delivery issues and implementing improvements to services; ▪ Persuading/influencing and implementing change; ▪ Understanding of HR policies and processes and experience of implementing them; ▪ Identifying and successfully achieving increased income and/or efficiencies. Key skills, knowledge and attributes • Ability to identify and implement change; • Excellent oral and written communication skills; • Excellent planning and organisational skills; • Visible supervisory skills, with the ability to motivate others to achieve positive change; • Flexible approach to work demands; • Understanding of health and safety requirements. Driving Access to a form of transport in order to meet the requirements of the post. Working Arrangements/Flexibility 37 hours per week. The post holder will be required to work outside normal hours including Bank Holidays, evenings and weekends and will be required to respond to out-of-hours enquiries to facilitate the needs of the Service.

2 days agoPermanent

Principal

CCMSBelfast, Antrim

See attached applicant pack for details

2 days ago

Assistant Facitilies Manager

National Gallery of Ireland2, Dublin

The Gallery is seeking an Assistant Facilities Manager to join the Operations Department on a permanent basis. Reporting to the Facilities Manager, the Assistant Facilities Manager is responsible for supervising all facilities maintenance activities including development works to ensure projects progress in accordance with Gallery requirements and to ensure a positive visitor experience at the Gallery. The Assistant Facilities Manager will be required to liaise with the Office of Public Works (OPW) with regard to all OPW held facilities contracts, to ensure the protection of the Gallery Collection is maintained, to monitor and manage contractors on site and to ensure standard of services are delivered against requirements, assisting in monitoring and managing the small works programme; and assisting with oversight of all facilities-related contracts. Areas of responsibility: Note: This job description is a guide to broad areas of responsibility and accountability and should not be regarded as a comprehensive listing. The job description may be subject to review in the view of new structures and / or the changing needs of the Gallery. All employees are required to be compliant with Gallery screening, security and Garda vetting procedures. Conditions of employment This job description is a guide to broad areas of responsibility and accountability and should not be regarded as a comprehensive listing. This may be subject to review in view of new structures and/or the changing needs of the Gallery. All employees are required to be compliant with NGI screening and Garda Vetting procedures. The post will be subject to a satisfactory medical check and successful completion of a successful probationary period. Applicants must be fluent in English and be eligible to work in Ireland. Citizenship Requirements Eligible candidates must be: 1. A citizen of the European Economic Area (EEA). The EEA consists of the Member States of the European Union, Iceland, Liechtenstein, and Norway; or 2. A citizen of the United Kingdom (UK); or 3. A citizen of Switzerland, pursuant to the agreement between the EU and Switzerland on the free movement of persons; or 4. A non-EEA citizen who has a Stamp 4 permission or a Stamp 5 permission. Please note: A 50 TEU permission, which serves as a replacement for Stamp 4EUFAM after Brexit, is considered equivalent to Stamp 4. To qualify candidates must be eligible by the date of any job offer. Job Details and Application Information Grade and Salary The salary for this position will be in accordance with the Senior Clerk of Works (PPC) pay scale, as per the 1 March 2025 pay adjustments. The salary scale for this position is as follows: €53,987.00; €55,775.00; €57,600.00; €59,428.00; €61,289.00; €63,145.00; €64,581.00; €66,002.00 · The starting salary will be at the first point on the scale, €53,987.00 per annum, or on a higher point of the scale, as appropriate to the successful candidate, if appointed from an existing public sector role (in accordance with Circular 08/2019). · Candidates should note the National Gallery of Ireland complies with Department of Public Expenditure and Reform regulations and guidelines on Public Service pay and conditions of employment. Superannuation: The successful candidate will be placed on the public sector pension scheme. Benefits: The Gallery provides staff the opportunity to participate in the tax saver and cycle to work schemes. Duration: Permanent Working hours: Full time, 5 days a week – 35 hours per week (net of breaks). Please note, flexibility is required and the successful candidate may be required to work occasional early mornings, late evenings and weekends. Closing date for receipt of applications : 13 July 2025 Interviews will be scheduled in July/August 2025. How to apply: To apply for this position, please provide the following documents (in PDF Format): · A cover letter, which should be no more than two pages · A CV, which should be no more than two pages Panel Candidates should note that at the end of the candidate assessment process a panel of successful candidates may be formed based on order of merit, from which future positions may be filled. Any personal data that you provide when applying for this position shall be processed in accordance with our Privacy Notice . At the National Gallery of Ireland, we value equity, diversity and inclusion. We recognise the benefits it can bring to our staff and our visitors interactions. We celebrate difference and want our people to be representative of all communities. If you require reasonable accommodation for any part of the application process, please do not hesitate to let us know. The National Gallery of Ireland is an equal opportunities employer

2 days agoFull-timePermanent

Project Administrator

National Cancer Registry of IrelandAirport Business Park, Cork

Role Purpose In line with our strategic plan, we are increasing our collaborations at a national and international level and increasing the number of research projects carried out annually. Our project portfolio is expanding, and we are looking for an experienced Project Administrator. This is a key role that provides comprehensive administrative support across multiple projects, helping to ensure projects, and project sub-tasks, are delivered on time and in compliance with all relevant requirements. The ideal candidate is enthusiastic, organised and hardworking with demonstrable experience in administering EU-funded projects. S/he will work closely with internal teams and external partners to ensure the smooth execution of projects activities and contribute to the overall success of our project portfolio. Key Responsibilities The responsibilities of the post are: Project Administration

2 days ago
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