Regulatory and Government Affairs
Regulatory Affairs Expert, Digital Software Products (m/f/d)
Address: Hafenstraße 9, Schweinfurt, BY 97424, Germany
Job ID: R0183591
- Overview
- Job Description
- Success Profile
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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
Your responsibilities:
- Creation, maintenance, appoval and control of global regulatory product documentation (e.g. global technical documentation, registration files)
- Content creation, alignment and approval of instruction of use/SM/IGL/label
- Provide guidance and expertise to help with identification of relevant compliance standards and associated testing
- Align change notifications to notified bodies/authorities (with SysQaRa)
- Perform conformity assessments (nMD, MD and other Products)
- Preparation of technical part for clinical evaluation report + plan
- Ensure regulatory product availability on global markets as per in-center commercial strategy
- Coordination of regulatory activities, alignment of regulatory strategy and roadmaps across the IC product groups
- Compile global registration file (STED) per product and customize/ supplement in preparation of local submission
- Preparation of free sale certificates and declarations for regulatory submissions
- Registration of medical devices, including trade goods and kits, as well as registration of manufacturing sites and new production lines
- Act as regulatory change project lead
Your profile:
- Technical/engineering /scientific background (degree)
- Minimum of 1 year professional experience in the field of regulatory or quality assurance medical devices / medical products
- Knowledge in the field of development and/or manufacture and control of medical devices and medical products (2 years)
- Required: Office (Excel/Word/Power Point), additional: QTRAK, PDM systems as PTC Windchill, FMEA tools
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 mobile 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.
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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