Regulatory and Government Affairs
Quality and Regulatory Expert (m/f/d)
Address: Fresenius Medical Care (UK) Ltd., Huthwaite, England NG17 2HU, United Kingdom
Job ID: R0167705
- Overview
- Job Description
- Success Profile
- Rewards
- Video Testimonials
- Connect
As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.
Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.
Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.
Job Description
Responsibilities:
Quality Tasks:
- Manage and maintain the local Quality Management System (QMS) as Local Management Representative.
- Implement corporate requirements and adapt them to local regulations, creating local instructions as needed.
- Establish, improve, and monitor quality processes, ensuring regulatory compliance for national business operations.
- Oversee documentation management, including change management and periodic reviews.
- Conduct gap analyses, risk assessments, and train staff on QMS procedures and general quality topics.
- Monitor medical device regulations and implement updates to ensure compliance.
- Manage complaints, act as Country Complaint Administrator, and oversee supplier quality management (audits, SCAR/SNCR).
- Support audits by Notified Bodies, Health Authorities, and corporate functions.
- Handle CAPA/NC processes and prepare management reviews and reports.
- Assist with technical operations and tender support through workflow tools.
- Liaise with national authorities (FSCA, recalls) and the RA team.
Regulatory Tasks:
- Register and maintain medical devices and importers with MHRA, ensuring compliance with UK/IE regulations.
- Handle Certificates of Free Sale and respond to technical/regulatory inquiries.
- Conduct internal and external audits, ensuring corrective actions are implemented.
- Update IFUs, packaging, and marketing materials; maintain Pre/Post-Market processes.
- Support supplier evaluations and stay up to date with evolving regulatory requirements.
- Act as Local Safety Officer (LSO) for product complaints, trend analysis, and vigilance reporting.
Your profile:
- Bachelor’s degree in Pharmacy, Chemical/Bioengineering, Health Sciences, or a related scientific discipline.
- Minimum 5 years of professional experience in quality management systems for medical devices or medicinal products in a regulated environment.
- Strong understanding of Quality Management Systems, ISO 9001/13485, UK/EU MDR/MDD, and Good Distribution Practice (GDP).
- Proficient in Microsoft Office and relevant QMS software (e.g., QTrack).
- Excellent communication skills in English, both written and verbal.
- Detail-oriented, conscientious, and quality-focused with strong organizational skills.
- Solid regulatory knowledge and ability to work in a structured, compliance-driven environment.
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Commpassionate Patient Care
Empathetic
Team Player
Detail Oriented
Efficient
Responsible
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Commpassionate Patient Care
Empathetic
Team Player
Detail Oriented
Efficient
Responsible
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Communicator
Compassionate
Detail Oriented
Relationship Expertise
Facilitator
Leadership
“You have a lot of independence...so the doctors trust you. You have to be able to make decisions on your own.”
Lesly,
Inpatient Services RN
Inpatient Services RN
We've got your back.
We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.
Healthcare
Continuing Education
Paid Time Off
Collaborative Environment
Additional Perks
401(k) Retirement Saving
By submitting your information, you acknowledge that you have read our privacy policy consent to receive email communications from Fresenius Medical Care AG.