Search Results: 130 vacancies
€52k - €55k per annum
...Hobson Prior is seeking a Regulatory Affairs Executive for the US and EU. This role is to be part of a dynamic team and involves supporting the team to achieve new marketing authorisations and maintain existing ones in line with company strategy. The successful candidate will...
...our clients operations, we are seeking applications from a suitably qualified and experienced Senior Business Process Analysts with Regulatory Project Control experience.
Job Purpose
Our client is running a global business transformation program accompanying a move of...
...Quality & Regulatory Professional in AIaMD (Artificial Intelligence as a Medical Device) Date: ASAP
Work Type: Please note this work will be ad-hoc and not for a set amount of hours or time period. You will develop and deliver trainings as desired by our clients as suited...
...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...
...of a 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,...
Medtronic GmbH
Galway
3 days ago
...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...
Life Science Recruitment
Galway
1 day ago
...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...
...site QA Director as the final arbitrator on critical quality decisions.
Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
Evaluates in conjunction with EHS new equipment/processes/...
...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:
~...
...Create and maintain development standards, training programs and operating procedures that ensure all development activities meet regulatory guidelines and comply with the Quality System.
Collaborate closely with functional areas such as Quality, Manufacturing and Regulatory...
...Assurance: Adhere to and enforce Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) to ensure product quality and regulatory compliance.
Order Fulfillment: Pick, pack, and prepare pharmaceutical products for outbound shipment according to customer orders...
...Job Title: Magellan Principal Business Process Analyst, Regulatory Product Controls
Job Title: Magellan Principal Business Process Analyst, Regulatory Product Controls
Reporting to: Snr Manager, Product Owner Regulatory Product Controls
Closing Date: 31...
...knowledge of design processes for medical devices. You will work closely with Quality and Design Assurance counterparts, as well as R&D, Regulatory, Clinical, and marketing functions to support early product design and manufacturing scale-up. You will support the development and...
€40k - €45k per annum
...compliance activities.
Assist in auditing the quality system, including processes, tools, and suppliers.
Support QA programs to ensure regulatory compliance.
Ensure effective closure of Quality System documents (Audit Actions, NCRs, CAPAs, etc.).
Collaborate with the team...
...a trusted advisor.
Strategy
Prepare cost analytics develop strategies to reduce costs.
Stay updated on industry trends, regulatory changes, and market dynamics that may impact cost adversely.
Process Improvement:
Identify opportunities to streamline processes...
...Job Description:
Responsibilities:
1.Stay abreast of the legal and regulatory landscape surrounding artificial intelligence in major developed countries.
2.Research and analyze global policies and regulations related to artificial intelligence.
3.Understand the underlying...
Remote job
...Collaborate with technical SMEs to design and develop training interventions for the Life Science Industry, focusing on Quality and Regulatory areas such as MDR, Risk Management ISO 14971, and Quality System ISO 13485.
Key Responsibilities:
Design bespoke learning development...
...related field.
Proven ability in using statistical analysis and experimental design for medical device testing.
Knowledge of regulatory standards such as 21CFR820, ISO 13485, and familiarity with MDR.
Benefits:
Competitive salary and benefits package.
Opportunity...
...successful candidate will lead the delivery of product development programs through collaboration and aligning with R&D, Clinical, Quality, Regulatory, Manufacturing, Commercial and Operations. Reporting to the PMO Manager, this individual will develop and track detailed project...
...(QMS) in compliance with EN ISO13485:2016, EU MDR and 21 CFR Part 820 regulations. You will oversee various quality assurance and regulatory activities, ensuring adherence to organisational and external requirements throughout the product lifecycle.
Responsibilities:...
