Regulatory and Government Affairs
(Senior) Expert Hygiene & Disinfection (m/f/d)
Address: Else-Kröner-Str. 1, Bad Homburg, HE 61352, Germany
Job ID: R0178148
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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.
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
In your role as (Senior) Expert Hygiene & Disinfection (m/f/d) you will be responsible to define a Hygiene and Disinfection strategy and ensure implementation in the product portfolio through execution in the Value streams Machine and Disinfection. You are supporting in addition different innovative sterilization methods and their validation by working on interpretation and adoption to applicable standards.
Your tasks
- Expert for all product groups concerning disinfectants, disinfection concepts and sterilization methods
- Pro-active surveillance of regulatory requirements for disinfection and biocides to foster the evaluation of production aids, raw materials as well as finished products
- Development of rationals to show the compliance of special sterilization methods like in line steam with the general sterilization standards on a global level
- Contact person to all units working on Hygiene and disinfection as well as sterilization methods and their validation, member in Cros functional teams in product development
- Support the global harmonization of disinfection and cleaning agents
- Set the strategic direction to In-Center Development groups in Value Streams, Registration/Regulatory Affairs and Product
- Create responses to authority requests to explain the sterilization concepts. Present during audits and document reviews the corresponding rationals
- Mid-term, a connection to the work in standard committees for sterilization and/or aseptic methods shall be established to understand and influence the generation of new standards in this field
- Support a Design Control approach and provide expertise to Value Streams and Q&R for compliance with applicable regulations (EU directive, local countries regulations)
Your profile
- Successfully completed master’s degree with scientific background in Microbiology, Chemistry and Hygiene; higher education, PhD preferred
- Experience of at least 5 years in Microbiology Laboratory or Sterilization Validation in pharmaceutical/medical field
- Minimum 2 years in working with DIN EN 556, DIN EN ISO 11135, DIN EN ISO 17665, DIN EN ISO 13408-1; EU Regulation 528/2012
- Advanced knowledge of sterilization standards like DIN EN 556, DIN EN ISO 11135, DIN EN ISO 17665, but also aseptic processing (DIN EN ISO 13408-1)
- Advanced knowledge of the EU Biocide regulation 528/2012
- Knowledge of further applicable standards (e. g. ISO13485 incl. MDSAP, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.) and regulations (e.g. MDR 2017/745)
- Knowledge of medical device risk management and related regulations
- Ability to lead cross functional teams in a complex matrix organization without disciplinary authority
- Strong team communication and problem-solving skills accompanied by analytical and entrepreneurial thinking
- Sees ahead to the future possibilities and translates them into breakthrough strategies
- Fluent in German and English, in written and spoken
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
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