Hot Regulatory Affairs Jobs

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client, a global medical device company are looking to hire a Senior Regulatory Affairs Specialist. This position will support NPD & product lifecycles while ensuring regulatory compliance is met throughout all regulatory processes. Roles & Responsibilities • Supporting new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. • Supports the product lifecycle through to obsolescence by assessing ch...

Location: Cork,

Regulatory Affairs Associate

Regulatory Affairs Associate Our client is looking for a regulatory affairs associate who will deal with the compliance and approval of products. This person will also be responsible for determining and supporting regulatory activities. Responsibilities • Use technical solutions for problem solving • Improve quality of projects • Use strong writing skills to clearly define and describe technical information • Analyse customer complaints • Identify trends and corrective actions • Review and assess of change control activities for po...

Location: Westmeath,

Quality, Compliance and Regulatory Affairs Coordinator

Quality, Compliance and Regulatory Affairs Coordinator Our client, one of the leading medical device distributors across Ireland and U.K are recruiting for QCRA Coordinator who will reporting to the QCRA Manager will the Quality, Compliance and Regulatory Affairs requirements. The successful candidate will manage the ongoing maintenance of our compliance requirements ensuring we meet and exceed our contractual and regulatory obligations, providing best practice in QMS. The Position ·Support the Quality Manager in relation to the maintenance of our ISO Quality Man...

Location: Dublin,

Risk Manager

Risk Manager - Medical Device-User Interface Life Science Recruitment has been exclusively engaged to source a Risk Manager for our client in Dublin. The ideal candidate will demonstrate subject matter expertise in the application of FDA and EU regulations and international standards related to design control, user interface and risk management. The individual must also possess an interest in maintaining an awareness of the device development landscape and have the technical drive and confidence to represent our client from an external perspective where necessary. The Risk Manager will...

Location: Dublin,

Clinical Trial Associate

Our Cork city-based biotech client is kicking off a major new recruitment project which will require the hiring of 100+ in-house Clinical Trials experts over 12 months. A superb office and team environment along with salary and benefits package will reward successful candidates here. Responsibilities The Clinical Trial Team provides clinical trial capabilities in support of clinical development. The Associate is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and close...

Location: Cork,

Reliability Engineer

In this role, you will provide technical expertise and guidance on Reliability Engineering and Asset Management while driving a culture of continuous improvements and reliability excellence through our MEP programme, and Support Maintenance management to deliver on its objectives. Key Responsibilities: Technical expert / SME on reliability engineering on site. Responsible for reliability standards within the department (equipment, processes, systems and utilities). Responsible for ensuring reliability standards are in line with standards set by the company and i...

Location: Cork,

QA Specialist (QC)

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Biologics as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities.Provide support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met. GENERAL SCOPE OF RESPONSIBILIT...

Location: Cork,

QA Senior Associate (Contract)

Plant QA Snr Associate Level 4 Dun Laoghaire Overview: The Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Senior Manager and is a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities. A...

Location: Dublin,

Active Devices Product Technical Specialist / Scheme Manager

We are currently working on an exciting opportunity with world renowned notified body. Who are seeking a Technical Specialist/Scheme Manager in the area of Acti

Location: Republic of Ireland,