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Hot Regulatory Affairs Jobs

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Search Results for Design Assurance

Job Title.	Location	Salary	Actions
Quality Specialist Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m... Location: Clare, Limerick, Limerick City, Republic of Ireland, Quality Specialist	EU	Not Disclosed
Quality Specialist Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m... Location: Clare, Limerick, Limerick City, Republic of Ireland, Quality Specialist	EU	Not Disclosed
Quality Specialist Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m... Location: Clare, Limerick, Limerick City, Republic of Ireland, Quality Specialist	EU	Not Disclosed
Quality Engineer Role: Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Assist with the implementation and development of the site QMS in line with the ... Location: Athlone, Connaught, Leitrim, Longford, Midlands, Quality Engineer	EU	Not Disclosed
Senior R&D Manager Job title: Senior R&D Manager Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and take great pride in provid... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior R&D Manager	EU	Not Disclosed
Senior R&D Manager Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta... Location: Athlone, Galway, Galway City, Senior R&D Manager	Athlone	Not Disclosed
Senior R&D Manager - Lifecycle Management Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta... Location: Galway, Galway City, Senior R&D Manager - Lifecycle Management	Galway	Not Disclosed
Senior R&D Manager - Lifecycle Management Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta... Location: Galway, Galway City, Senior R&D Manager - Lifecycle Management	Galway	Not Disclosed
Senior R&D Manager - Lifecycle Management Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta... Location: Galway, Galway City, Senior R&D Manager - Lifecycle Management	Galway	Not Disclosed
Senior R&D Manager - Lifecycle Management Job title: Senior R&D Manager, Lifecycle Management Location: Ballybrit, Galway Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are a Medical Device company who have recently been acquired by a multinational, a global leader in neurovascular care. And a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.My client invests in their people, and ta... Location: Galway, Galway City, Senior R&D Manager - Lifecycle Management	Galway	Not Disclosed

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Design Assurance Career Profile

Design Assurance

Design Assurance engineers provide quality support to R&D and assist in the scale up and commercialization of product.

Role/Responsibility

Support risk management activities
Evaluation of new products, assuring the safety and efficacy of the devices
Design verification and shelf life protocols / reports
Qualification and validation activities
Knowledge of regulatory compliance requirements for product design, development, transfer and commercialization activities
Adhere to Quality System and Design Control requirements
Root cause investigations; drive problem solving efforts for quality issues
Manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release
Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions
Support customer complaint analysis and post market surveillance activities
Generate and approve change requests

Skill/Experience

Bachelor's Degree in Engineering or Science related Discipline (Master's Degree desirable)
A minimum of 2 years experience, with at least 1 years experience in the Medical Device industry
A minimum of 1 years experience in product & process development

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