QRC Specialist UKI

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Quality Regulatory Compliance (QRC) Specialist - Remote, UKI

We're hiring for an experienced QRC specialist who will be responsible for supporting the QRC Manager and the QMS Manager in maintaining the global Quality Management System and identifying the opportunities for improvement. 

Job Duties and Responsibilities

• Support in Maintaining and controlling a Quality Management System based on ISO9001, ISO 13485 and GetAligned
• Assisting in the investigation of NC handling in various tracking systems and following up on the corrective actions
• Assist in (FSCA) Field Safety Corrective Actions 
• Support and/or performing internal and external audits and support the QMS Manager with the follow up of these audits
• Support on all related CAPA’s and non-conformities
• Assisting in monitoring and maintaining quality and compliance targets
• Preparing and analysing information for the purpose of Management Review
• Stay alert on all regulatory changes, analyze the changes, and communicate, implement the applicable requirements
• Implementation of GetAligned and the regional RQMS
• Support in ensuring products are registered with the authorities (MHRA) within the required deadlines
• Assist in any Regulatory changes, analyse, communicate, anticipate and implement the applicable requirements
• Interact with the Authorities. Interlocutor in the framework of inspections of Authorities. Organising and contributing to inspections. Evaluate non-conformities and implement appropriate corrective/preventive actions
• Support the sales organisation with the complaint handling, ensure that the SSU’s are recording the complaints through the associated tools, within the time limits
• Ensuring the availability of the results of investigation and responses to the Authorities/customers within the regulatory timeframe if required
• Ensure appropriate documentation is maintained
• Receive, implement, monitor and close the FA’s (Field actions: ship hold, Field Safety Corrective Actions), this within the timeframes
• Support and organise trainings and awareness to the SSU’s in Regulatory Affairs, Post-Market Surveillance, QMS 
• Summarise and analyse the local/regional KPI’s (UKI & Nordic), implement actions to achieve the defined targets and communicate the KPI's to the QRC director NE
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements
• As part of this job, it may be required to support QRC in other regions

Who you are:

At Getinge, we are looking for passionate individuals, who are agile, resilient, take responsibility for their development and focus on achieving excellence.  We provide an environment for Forward Thinkers, Game Changers and Team Players to thrive in. If you enjoy collaboration and working in diverse and international teams, never compromise on quality and always act responsibly remembering that our customers come first, we would love to hear from you. 

What you bring:

• A degree is desirable but not essential.
• Experience in QMS in the medical device industry is desirable
• Good knowledge of Microsoft Excel, Word & Powerpoint
• SharePoint, E-learning, TrackWise experience is desirable
• Knowledge of ISO 13485 / ISO 9001 is desirable
• Knowledge in Medical device regulation (MDR, UKMDR), MDD (DIR 93/42/CEE) and local medical device regulations is desirable
• Excellent language skills in English – verbal and written
• Ability to travel (National and international) and work remotely

What we offer:

We offer a competitive compensation and benefits package, to ensure we support your well-being and goals. We understand that a healthy work-life balance is important, so we offer a flexible approach to working patterns as well as a range of enhanced family friendly policies.

Along with a competitive salary and clear progression scheme, we offer private healthcare, travel and subsistence allowance, shopping discounts through Perkbox, and an Employee Assistance Programme. We have achieved the Better Health at Work Scheme Gold Award, through providing a range of resources, meetings, activities and training to employees to support their physical and mental health and wellbeing.

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.