? (High Salary) Regulatory Affairs Officer
2 days ago
ABOUT THE ROLE Reporting to the Regulatory Affairs Manager the Regulatory Affairs Officer based on the Coleraine site is responsible for supporting the company in the maintenance of the Regulatory Affairs function, achieving compliance with changing regulations and standards, and meeting company goals and targets by providing a high level of administrative support and registration co-ordination.
KEY ACTIVITIES Manage, prepare, and collate required documentation to support submissions for product approvals and maintenance.
Compilation of supporting documents for product registrations.
Liaise with Commercial Teams to ensure customer requests are met.
Collate data relating to device sales and customer complaints in respective territories.
Maintaining Medical device Technical Files in line with Notified Body/Approved Body and regulatory requirements.
Ensure adequate control of regulatory documentation and procedures are maintained.
Gather and trend Post Market Surveillance (PMS) Data.
Liaise with device users, customers, distributors, and importers as needed.
Administration of Field Safety Corrective actions.
Liaise with device users to obtain further information in relation to reportable events.
Ensure that key information relating to PMS and Vigilance is relayed to the Regulatory Affairs Specialist as appropriate.
Support review of clinical data and real-world data for compilation within Clinical Evaluation Reports.
Perform risk assessments on importers and distributors and ensure appropriate agreements are in place and kept up to date.
Supporting the Regulatory Affairs Manager in achieving and maintaining compliance with EU MDD, MDR, REACH, WEEE, US FDA and other regulatory requirements in countries where our products are used.
Support regulatory administrative activities within new product development projects.
Critical Success Factors Providing administrative support during external and unannounced audits.
Responding to internal requests for technical and/or regulatory information.
Monitoring changes to regulatory legislation affecting the company.
Liaise effectively with other departmental staff.
Ensure that confidential company information is protected.
Other To adhere to the companys Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible To be responsible for your own health and safety and that of your colleagues, in accordance with the companys Health and Safety policy To adhere to the companys Quality policy and Environmental policy To undertake other duties as may be reasonably required KEY SKILLS Essential Relevant experience in a manufacturing environment.
Educated to GSCEs level or equivalent.
Good verbal communication skills.
Proven experience with Microsoft office suite.
Desirable Relevant experience in a similar role.
Previous experience conducting risk assessments.
Degree educated in Law, Business or Science.
Knowledge of MDD, EU MDR, UK MDR, ISO13485 and/or MDSAP.
Previous experience of electromechanical devices KEY WORKING RELATIONSHIPS Internal Group Operations.
Group Commercial.
External Regulatory authorities.
Customers, Distributor, Importers and Authorised Representatives.
Notified bodies and Approved bodies.
ADDITIONAL INFORMATION Ability/willingness to develop within the role.
Ability/willingness to attend training courses in relation to the role and the needs of the department.
Ability/willingness to travel to other Eakin Group sites as needed.
Skills: Regulatory Submissions Regulatory Affairs Management Regulatory Submissions Post Market Surveillance
-
Regulatory Affairs Officer
6 months ago
Coleraine, United Kingdom Eakin Healthcare Group Full time**ABOUT THE ROLE** Reporting to the Regulatory Affairs Manager the Regulatory Affairs Officer based on the Coleraine site is responsible for supporting the company in the maintenance of the Regulatory Affairs function, achieving compliance with changing regulations and standards, and meeting company goals and targets by providing a high level of...
-
Regulatory Affairs Director
7 days ago
Coleraine, United Kingdom Eakin Healthcare Group Full timeAbout the RoleAs a key member of our Eakin Healthcare Group team, you will be responsible for providing regulatory direction and guidance within our Respiratory therapeutic area in Coleraine. Reporting to the Head of Clinical & Regulatory Affairs, you will ensure the development of regulatory strategies supporting New Product Development (NPD) and Notified...
-
Regulatory Affairs Director
2 weeks ago
Coleraine, United Kingdom Eakin Healthcare Group Full timeAbout Eakin Healthcare GroupWe are a leading healthcare organization dedicated to delivering innovative solutions for respiratory and wound care. Our team is passionate about making a difference in people's lives, and we're seeking a highly skilled Regulatory Affairs Manager to join our Respiratory therapeutic area in Coleraine.Job Description:This is a...
-
Regulatory Compliance Specialist
1 week ago
Coleraine, United Kingdom Eakin Healthcare Group Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Coleraine, responsible for providing regulatory direction and guidance within our Respiratory therapeutic area.Key ResponsibilitiesEstablish and implement regulatory strategies to support New Product Development (NPD) and Notified Body...
-
Hr Officer
3 days ago
Coleraine, United Kingdom Reed Specialist Recruitment Full timeReed HR is delighted to support our long-established client in the Coleraine area who wishes to recruit a HR Officer to cover maternity leave.The successful candidate will be able to demonstrate a proactive approach with excellent interpersonal skills that include the ability to work with people at all levels of the organisation and with a flexible approach...
-
Chemical Engineer
5 months ago
Coleraine, United Kingdom Eakin Healthcare Group Full timeAt Eakin Healthcare we put our patient at the heart of everything we do. Fifty years ago, it all started with one man’s mission: pharmacist, Tom George Eakin. He saw his patients struggling with leaking urostomy pouches and decided enough was enough. He got to work and formulated what would become the game-changing, eakin Cohesive® seal. Fast forward...
-
Office Supervisor
5 months ago
Coleraine, United Kingdom apetito Full timeOverview: The **Office Supervisor**, for Wiltshire Farm Foods Coleraine, must be passionate and have the energy and commitment to support the Retail Sales and Operations Manager to create an exemplar of outstanding performance in customer service and sales. Customer service and empathy for the needs of our predominately elderly customers is at the heart of...
-
Office Supervisor
5 months ago
Coleraine, United Kingdom apetito Full timeOverview: The **Office Supervisor**, for Wiltshire Farm Foods Coleraine, must be passionate and have the energy and commitment to support the Retail Sales and Operations Manager to create an exemplar of outstanding performance in customer service and sales. Customer service and empathy for the needs of our predominately elderly customers is at the heart of...
-
Office Administrator
6 months ago
Coleraine, United Kingdom Gerni NI Ltd Full time**About us** Gerni NI, part of The Oliver Exorna Group is a small hardware equipment sales and servicing business located in Coleraine. Our work environment includes: - Modern office setting - Staff canteen Office Administrator **Duties**: - Maintain office supplies inventory and place orders as needed - Assist with order entry and clerical tasks -...
-
Hr Officer
3 days ago
Coleraine, United Kingdom Hunter Savage Full timeExcellent, HR Officer, 11 month fixed term contract job with our client, a market leading, commercial distribution Group headquartered in Coleraine.This is a fantastic opportunity for an HR Administrator or HR Officer eager to take the next step in their HR career, joining a fast paced, expanding HR team.Immediate start available, if possible, and an...
-
HR Officer
1 month ago
Coleraine, United Kingdom Black Fox Solutions Full timeHR Officer Coleraine Salary Dependent on Experience This is an exciting opportunity to join a leading Coleraine based FMCG wholesaler as their new HR Officer. This role will initially be a fixed term 11-month contract. The role: Coordination of internal & external training. ER including investigations, disciplinary & grievance. End to end recruitment &...
-
Office Administrator
6 months ago
Coleraine, United Kingdom Riada Resourcing Full time**Contact Heather Lennox | 028 7032 6600** **Office Administrator - Coleraine - Permanent** **About the role**: - Salary: c22,000 per annum (£Negotiable depending on experience) - Full time / Permanent - 30 days annual leave - Local business You will be working in a key role liaising with the MD and Operations Manager responding to customer enquiries,...
-
HR Officer
1 month ago
Coleraine, United Kingdom Black Fox Solutions Full timeHR OfficerColeraineSalary Dependent on ExperienceThis is an exciting opportunity to join a leading Coleraine based FMCG wholesaler as their new HR Officer. This role will initially be a fixed term 11-month contract.The role:Coordination of internal & external training.ER including investigations, disciplinary & grievance.End to end recruitment &...
-
HR Officer
1 month ago
Coleraine, United Kingdom Black Fox Solutions Full timeHR OfficerColeraineSalary Dependent on ExperienceThis is an exciting opportunity to join a leading Coleraine based FMCG wholesaler as their new HR Officer. This role will initially be a fixed term 11-month contract.The role:Coordination of internal & external training.ER including investigations, disciplinary & grievance.End to end recruitment &...
-
Homecare Officer
5 months ago
Coleraine, United Kingdom Health and Social Care Trust Full time**Branch**:Coleraine/Ballymoney locality **Location**:Armour Site: Home Care Office **Directorate**: Community Care Division **Functional Area**: Domiciliary Care Service **Salary**: Band 5 (£27k - £33k) **Contract Type**:Temporary **Opening date**: 22/08/23 **Closes**: **Interview Dates**: tbc **Notes**: A waiting list may be compiled for any...
-
HR Officer
7 days ago
Coleraine, United Kingdom REED Specialist Recruitment Full timeJob Title: HR Officer - People ChampionAbout the Role:We are seeking an experienced HR Officer to join our team in Coleraine. The successful candidate will be responsible for providing HR Generalist support across Operations and Head Office functions in NI, Scotland & Republic of Ireland.Main Responsibilities:Drive the HR Strategy across the group by...
-
High-Voltage Electrician
7 days ago
Coleraine, United Kingdom Hunter Savage Full timeAbout YouTo succeed in this role, you will need:A minimum of 2 years' post-apprenticeship experience in a similar role.A recognised Vehicle Apprenticeship with a minimum of NVQ Level 3 or equivalent in a relevant trade or discipline.Excellent diagnostic ability where applicable.An awareness of customer needs and the ability to produce sound and safe...
-
Quality Assurance Officer
6 months ago
Coleraine, United Kingdom Optimum Care Full timeAre you passionate about delivering high-quality care and ensuring the well-being of clients? We are seeking a dedicated and compassionate individual to join our Coleraine team as a Quality Assurance Officer. Covering the Coleraine and surrounding areas, you will report to our Optimum Care office in Coleraine. This job role forms an integral and important...
-
Quality Assurance Officer
5 months ago
Coleraine, United Kingdom Optimum Care Full timeAre you passionate about delivering high-quality care and ensuring the well-being of clients? We are seeking a dedicated and compassionate individual to join our Coleraine team as a Quality Assurance Officer. Covering the Coleraine and surrounding areas, you will report to our Optimum Care office in Coleraine. This job role forms an integral and important...
-
Marketing Officer, AI Collaboration Centre
1 month ago
Coleraine, United Kingdom Ulster University Full timeJob Purpose: We are seeking a highly skilled Marketing Officer to lead the delivery of marketing activity for the Artificial Intelligence Collaboration Centre (AICC). The successful candidate will be responsible for producing high-quality marketing campaigns, materials, and publications that support a strong clear brand positioning based on deep customer...