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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.
Regulatory Affairs Specialist - 12 Months Fixed Term Contract (Remote, UK)
Getinge are seeking an experienced and diligent Regulatory Affairs Specialist to join us on a 12 Months Fixed Term Contract to support the Getinge UKI sales organisation to meet all required laws, guidelines, rules and regulations and be the interface between customers, regulatory bodies and manufacturers to ensure customer satisfaction and full compliance.
Key Duties And Responsibilities
- Ensuring products are registered appropriately according to local registrations (MHRA / EUDAMED) within required deadlines
- Ensuring compliance with applicable regulations and standards, e.g. UK MDR, EU MDR, ISO 13485, ISO 9001
- Organizing and contributing to internal / external / supplier audits
- Participate in the evaluation of non-conformities and implementation of corrective / preventive actions
- Reviewing Regulatory Information / Technical Files
- Support the Regulatory Manager with assessment / communication / implementation of regulatory changes
- Support the Regulatory Manager with project for regulatory database implementation
- Provide Regulatory support across the SSU, as required
- Ensuring any complaints received are registered within a timely manner
- Support the SSU with distribution of complaint investigation results, where applicable
- Support the SSU with responses to authorities, where required
- Ensure correct documentation is maintained
Support The QRC Director In The Following QA Activities
- Supporting with the investigation of NC and CAPAs in various tracking systems
- Identifying training needs and recommendations to achieve or maintain necessary employee competencies
- Ensuring activities within Quality Plans are carried out, as applicable
- Preparing information for the purpose of Management Review
- Developing, maintaining, reviewing QMS procedures to ensure compliance to applicable standards and regulations.
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. They never compromise on quality and always act responsibly remembering that our customers always come first. They enjoy collaboration and working in diverse and international teams and embrace the future.
If you love change, we can make sure that you stay that way!
Knowledge/Skills/Experience
- Bachelor or Master degree in Regulatory Affairs, Engineering, Life Sciences or a related field, or related field experience
- 2+ years of experience in Regulatory Affairs / Post Market Surveillance
- Good knowledge of QMS, ISO 9001 / 13485
- Good knowledge of medical device regulations (UK MDR / EU MDR / EU MDD)
- Knowledge of the MHRA registration process is an advantage
- Internal auditing experience is an advantage
- Previous experience of NC / CAPA is an advantage
- Excellent MS Office skills
- Previous use of Sales Force / SAP / TrackWise is an advantage
- Ability to work with cross-functional, multi-national teams
- Document and Record management
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 Silver 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.
