Average salary: €55,094 /yearly
More statsSearch Results: 135 vacancies
...Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting...
...I am partnering with Abbott Rapid Diagnostics to hire a Regulatory Affairs Specialist II on an initial on 12 month contract to support an exciting new project.
Working Model: Remote
The Role:
In this role you will prepare documentation for EU Technical Files and...
...company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Our Purpose
At our Regulatory Affairs department in Medtronic, plc, based in Galway our mission is to develop innovative strategies for regulatory approval, anticipate...
...the documentation administrator is to help ensure compliance with regulatory requirements, quality standards, and internal procedures... ...across various departments, including Quality Assurance, Regulatory Affairs, R&D, Manufacturing, and Supply Chain, to ensure alignment and consistency...
...pharmaceutical equipment and building utilities within our site.
Effective management of projects ensuring compliance with GMP and regulatory requirements. The role will add additional expertise to the engineering function by supporting compliance with technical engineering...
...plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures and applicable regulatory standards. The Quality Engineer supports design transfer activities to ensure on-going compliance and continuous improvement. The...
...activities. You will advance platform development and drive existing product support through interactions with Commercial, R&D, Regulatory, Quality, Medical Affairs and other key business stakeholders.
You will provide direct technical and organizational leadership to the Science...
...controls, financial analysis, planning and reporting accountabilities and transparency, meeting deliverables and timelines.
• Ensure regulatory compliance with Society policies, Charity Act and regulations, accounting standards and other legislation, standards, or codes.
•...
...as compiling various documents for management on an ad hoc basis.
Within this role you will:
Ensure compliance to applicable regulatory standards and current GMP procedures and practices.
Control of non-conforming product and documentation of non-conforming events....
...Create and maintain development standards, training programs and operating procedures that ensure all development activities meet regulatory guidelines and comply with the Quality System.
Develop and maintain relationships with third level institutions, engineering test...
...Senior Reg Affairs Specialist - Post Market
Job title: Senior Regulatory Affairs Specialist – Post market
Location: Parkmore, Galway. 1-2 days a week on site
Benefits: Top salary, Bonus, pension, healthcare, hybrid working
Overview:
My client are a fast-paced...
...and providing training/coaching to lower-level scientists.
Collaborate closely with Quality, Design Assurance, Manufacturing, and Regulatory functions to support compliant product design, document control, external audits, and certification activities.
Requirements:
~...
...on finished products & raw materials using the correct procedures to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs.
To provide technical support as required by management.
KEY...
...culture of continuous improvement within the department, encouraging risk-taking and innovation.
Ensure departmental adherence to regulatory and GMP requirements, promoting quality and customer satisfaction in all activities.
Proactively identify and mitigate technical...
...qualified and experienced Senior Business Process Analysts with Regulatory Project Control experience.
Job Purpose
Our client is... ...objectives
Requirements
~ Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Science, Computer Science, Business or related...
...operations, we are looking for a Senior Business Process Analyst with Regulatory Project Control experience for a global transformation program.... ...objectives
Requirements
~ Bachelor's degree in Regulatory Affairs, Quality, Engineering, Science, Computer Science, Business or...
...and person directly responsible to represent IDEM with outside Regulatory authorities (FDA, NMPA, Notified Bodies, MoH, WHO) on design quality... ..., change control and complaints.
Collaborate with Regulatory Affairs and R&D to establish appropriate product filing strategies and...
...Hybrid position.
As the Principal Business Process Analyst Regulatory Product Controls, you will play a key role in ensuring the successful... ...field required.
~5+ years direct medical device Regulatory Affairs experience with international experience at a divisional or...
...pharmaceutical equipment and building utilities within our site. Effective management of projects ensuring compliance with GMP and regulatory requirements.
RESPONSIBILITIES:
· Management of engineering projects, capital projects, compliance to GMP standards
· Preparation...
...Materials, API and Excipients using the correct Analytical procedures to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs.
· Preparation of ECP’s and Vendor Approval.
· Analytical Method...