Regulatory and Government Affairs

Regulatory Affairs Expert (m/f/d)

Address:

  • Frankfurter Str. 6-8, St. Wendel, SL 66606, Germany
  • Else-Kröner-Str. 1, Bad Homburg, HE 61352, Germany

Job ID: R0204740

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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.

A female nurse examining her patient

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.

A female nurse examining her patient

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.

A female nurse examining her patient

Inpatient RNs at Fresenius Medical Care perform dialysis treatments on an acute patient population in a hospital setting, including ICU, ER, Rehab, and Med/Surg units. What makes this role truly unique is the level of autonomy you’ll enjoy. Inpatient nurses are specifically accountable for administering and assessing each patient’s treatment plan. And because dialysis is a critical treatment for many hospital procedures and health conditions, you’ll have the opportunity to work with a wide variety of patients. Ideal candidates possess leadership skills and independence needed to make quick decisions in a fast-paced environment. Must be capable of educating patients and providing exceptional customer service to our partners. Six months to one year of dialysis experience or some form of critical care nursing experience are also required.

A female nurse examining her patient

Job Description

We are looking for a Regulatory Affairs Expert - Critical Care/Peritoneal Dialysis (m/f/d) in Bad Homburg or St. Wendel.

Your responsibilities:

  • Manage creation, maintenance, and approval of global regulatory documentation (e.g., technical files, registration dossiers, labeling, IFUs)
  • Support global product registrations, renewals, and submissions, including compilation of STED files, declarations, and Free Sale Certificates
  • Ensure compliance with applicable standards, perform conformity assessments, and align product risk classifications
  • Provide regulatory input for design changes, development projects, and change control processes
  • Coordinate global regulatory strategy, activities, and communications across markets
  • Lead regulatory impact assessments, change implementation, and stakeholder alignment
  • Support creation and review of Declarations of Conformity, marketing materials, and product-related documentation
  • Collaborate on clinical evaluation content and provide expert opinions and risk evaluations
  • Assist with registration of manufacturing sites, kits, and trading goods; support tenders and pharma-related device submissions

Your profile:

  • Technical/Engineering/Scientific background (PhD, MBA, or relevant specialized education)
  • Minimum 1 year professional experience in Regulatory or Quality Assurance for Medical Devices/Medicinal Products
  • 2+ years knowledge in development, manufacture, and control of Medical Devices/Medicinal Products
  • Familiarity with quality management and risk management standards (e.g., ISO 13485, ISO 14971, EU GMP Guidelines, FDA 21 CFR §820.250)
  • Understanding of medical device regulations (MDD 93/42/EEC, MDR 2017/745)
  • Knowledge of internal/external processes and corporate Quality Management requirements
  • Expertise in sterilization processes, clean room requirements, and validation methods
  • Regulatory knowledge on global registration
  • Fluent in English and German

Our offer for you:

There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:

  • The option to work on a hybrid basis
  • Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
  • Individual opportunities for self-determined career planning and professional development
  • A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
  • A large number of committed people with a wide range of skills, talents and experience
  • The benefits of a successful global corporation with the collegial culture of a medium-sized company

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.

Success profile proportion

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.

Success profile proportion

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.

Success profile proportion

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.

Success profile proportion
“I successfully completed the RN program and went on to hold the position of Staff RN, Charge Nurse, and finally Clinical Manager.”
Rosalyn,
Clinical Manager
“Every day I walk in I am changing lives for the better and working to inspire my patients.”
Andrew,
Patient Care Technician
“I am a member of an outstanding team that helps patients gain more control, achieve tangible goals, and live better lives.”
Tony,
Outpatient Services RN
“My goal is to make sure that our patients keep their mobility and quality of life. This goal is really personal for me. My own father always had really bad vasculature in his leg and never had access to the kind of care we offer — eventually he lost blood flow and mobility. Knowing what he went through makes me even more committed to our mission.”
Warren J.
Azura Regional Vice President

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.

Watch what empowers us.

Watch what empowers us.

Watch what empowers us.

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