Regulatory and Government Affairs

(Senior) Material Compliance Expert (m/f/d)

Address: Else-Kröner-Str. 1, Bad Homburg, HE 61352, Germany

Job ID: R0171258

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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

In your role as (Senior) Material Compliance Expert (m/f/d) you will be responsible for material compliance evaluation of medical devices according to the Regulation (EU) 2017/745 (MDR) and other regulatory guidelines/requirements and to ensure documentation of EHS compliance of FME’s product portfolio.

Your tasks

  • Evaluation of raw materials as well as finished products concerning regulatory EHS-requirements on substances and materials
  • Contact person to external suppliers concerning the before mentioned requirements
  • Collaborate with engineering teams from the early stages of development to provide material compliance input and support
  • Support in second source and material change projects
  • Support regulatory affairs and value stream interfaces with required information regarding material compliance, e.g. tender requests
  • Supports creation and maintenance of dossiers for Nordic eco labeling (Nordic Swan)
  • Providing summaries of expert advice (e.g. author of expert statements)
  • Acting as sponsor in Material Safety Data Sheet generation
  • Expert within cross functional teams concerning EHS material compliance questions

Your profile

  • Successfully completed scientific background (master’s degree) in chemistry, material science, biology, or related fields
  • Advanced knowledge of material compliance / EHS related regulations and standards (REACH, POP, MDR, RoHS, CLP, Packaging etc.) 
  • First years of experience in regulatory affairs or quality environment in pharmaceutical/medical device field
  • Knowledge of applicable Quality Management standards (e. g. ISO 13485, ISO 14971, ICH Q10, EU GMP, FDA 21 CFR §820.1, etc.)
  • Knowledge of internal and external processes and structures, and of the (global) corporate quality management requirements
  • Knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.)
  • Knowledge of medical device risk management and related regulations
  • Good and professional relationship to and communication with international colleagues and superiors
  • High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work independently as well as within the cross-functional team
  • Fluent in English, in written and spoken, and a good knowledge of German

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.

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