CrawlJobs Logo

Expert Biocompatibility

freseniusmedicalcare.com Logo

FMS USA Fresenius Mgmt Services Inc

Location Icon

Location:
Germany , St. Wendel

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 125,000 employees. Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide! In your role as (Junior) Expert Biocompatibility (m/f/d) you will be responsible for biocompatibility evaluation of medical devices in the framework of Regulation (EU) 2017/745 on medical devices (MDR), ISO 10993-series and other regulatory guidelines/requirements.

Job Responsibility:

  • Support Performance of safety and risk assessments for medical devices based on the used raw materials, on extractable and leachable chemicals or on biocompatibility studies (ISO 10993 series)
  • Drive planning, interpretation and evaluation of analytical and biological tests performed by internal or external laboratories under supervision of experienced team members
  • Assist in compilation of overall biological safety assessment according to ISO 10993-1
  • Support in deriving biocompatibility strategy details including material characterization, sampling of different product groups during new product developments or material/product changes
  • Acting as sponsor, study monitor and contact for chemical/ biocompatibility studies in internal and external laboratories
  • Ensure sufficient support of biocompatibility projects and coordinate how to apply overarching strategies
  • Align sampling and testing strategies and support product responsibles how to apply these
  • Coordinate global alignment of laboratory partners (internal and external) as well as methods applied
  • Overall responsibility for the assigned product groups and related biocompatibility files
  • Contribute to supplier agreements and specifications for biocompatibility requirements as well as material selection
  • Observe upcoming regulation changes and ensure timely implementation considering state-of-the art methodology

Requirements:

  • Successfully completed bachelor’s or master’s degree in scientific or engineering or a similar technical field required, such as medical technology
  • Related working experience: first years to 5 years, depending on level (Junior Expert / Expert)
  • First experience in writing biocompatibility evaluations
  • Knowledge with biocompatibility-testing and evaluations of medical devices according to ISO 10993
  • Application of Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO 13485, and ISO 14971
  • Knowledge with medical device risk management process and related regulations
  • Experience with product or design and development or quality engineering of sterile disposables utilizing various plastic processes such as injection molding and extruding
  • Ability to communicate technical information to non-technical audiences
  • Familiar with agile methodology
  • First Experience with ALM and PDM systems
  • Familiar with durables and disposables of medical devices
  • Fluent in German and English, both written and spoken
  • Willingness to travel on an average monthly cadence and to work in different time zones
What we offer:
  • 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

Additional Information:

Job Posted:
February 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Expert Biocompatibility

Toxicological Expert

At Fresenius Medical Care, we are the global leader in kidney care, committed to...
Location
Location
Germany , St. Wendel; Bad Homburg
Salary
Salary:
Not provided
freseniusmedicalcare.com Logo
FMS USA Fresenius Mgmt Services Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Successfully completed master’s degree in scientific or engineering or a similar technical field required, such as medical technology
  • Related working experience: 2–8 years, depending on level (Expert / Senior Expert)
  • Advanced training in toxicology, e.g., avocational studies, trainings, etc.
  • Certification as toxicologist or started education highly welcome, e.g., European Registered Toxicologist (ERT) or Board Certified Toxicologist (DABT)
  • Deep knowledge of ISO 10993 standard series including respective trainings
  • Significant experience in chemical-analytical as well as biological biocompatibility testing as well as evaluations
Job Responsibility
Job Responsibility
  • Derive strategy for toxicological evaluations and risk assessment acc. ISO 10993-17 for different product groups and therapies
  • Support biocompatibility strategy details including material characterization, sampling of different product groups, chemical-analytical and biological testing as well as overall evaluation
  • Analyze results of chemical-analytical and biological testing for their toxicological profiles
  • Create toxicological risk assessments for leachables and extractables studies for all relevant products
  • Perform toxicological evaluations of substances or if needed assignment of mandates for external toxicologists and review of respective assessments
  • Support and coordinate with projects and product responsibles how to interpret the findings and measures to be taken, e.g., change of materials or production processes, measures to minimize leachables, etc.
  • Revise existing toxicological risk evaluations or reports for substances to comply with state-of-the-art data
  • Drive the global exchange and knowledge increase wrt toxicological evaluation of relevant substance groups and respective measures
  • Support with toxicological expert know-how and contribute to the overall biocompatibility reports for the products
What we offer
What we offer
  • 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
Read More
Arrow Right

Senior Scientist-Biocompatibility and E&Ls

Lucideon M+P is expanding our advanced chemistry and biocompatibility capabiliti...
Location
Location
United States , Greenville
Salary
Salary:
70000.00 - 100000.00 GBP / Year
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A degree in Chemistry, Biochemistry, Materials Science, or a related field
  • Experience in Extractables & Leachables (E&L), ISO 10993, or medical device analytical chemistry
  • Hands-on expertise with mass spectrometry and trace-level analysis
  • Strong communication skills and experience supporting client-facing scientific engagements
  • Experience leading technical programs or mentoring scientific staff
Job Responsibility
Job Responsibility
  • Lead and expand Extractables & Leachables (E&L) and ISO 10993 biocompatibility chemistry services
  • Design, execute, and oversee advanced analytical chemistry studies, including mass spectrometry and advanced chemistry workflows (e.g., LC-MS, GC-MS, ICP-MS, IC)
  • Prepare and support regulatory submissions (FDA, ISO) with high-quality data packages
  • Develop new testing methodologies, protocols, and service offerings aligned with industry needs
  • Serve as a subject matter expert at technical conferences, standards committees, and working groups
  • Engage with clients to understand challenges, design study strategies, and support product development
  • Manage scientific projects, timelines, deliverables, and mentor technical staff
What we offer
What we offer
  • Healthcare benefits including medical, dental, and prescription coverage
  • 401(k) with company matching
  • Tuition assistance, disability insurance, and life insurance
  • Generous paid time off
Read More
Arrow Right
New

Lawson Senior AP Processor

THE ACCOUNTS PAYABLE PROCESSOR WILL SUPPORT DAILY AP OPERATIONS ACROSS BOTH PO A...
Location
Location
United States , Houston
Salary
Salary:
60.00 USD / Hour
medasource.com Logo
Medasource
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • LAWSON (INFOR) EXPERIENCE REQUIRED
  • EXCEL PROFICIENCY REQUIRED
  • DEMONSTRATED ABILITY TO MANAGE HIGH-VOLUME INVOICE PROCESSING
  • HEALTHCARE AP EXPERIENCE REQUIRED FOR PO-SIDE ROLES
  • HEALTHCARE EXPERIENCE NOT REQUIRED FOR NON-PO ROLE
  • STRONG CUSTOMER SERVICE AND VENDOR COMMUNICATION SKILLS
  • BACHELOR’S DEGREE PREFERRED OR EQUIVALENT WORK EXPERIENCE
Job Responsibility
Job Responsibility
  • PROCESS AND VALIDATE PO-BASED INVOICES WITHIN LAWSON
  • OWN THE 3-WAY MATCH (PO, RECEIVING, INVOICE)
  • RESEARCH AND RESOLVE PRICE DISCREPANCIES, MISSING RECEIPTS, AND VENDOR ISSUES
  • PARTNER CLOSELY WITH SUPPLY CHAIN / MATERIALS MANAGEMENT TO RECONCILE EXCEPTIONS
  • MANAGE VENDOR INQUIRY MAILBOXES AND COMMUNICATION
  • HANDLE VENDOR DISCUSSIONS ON REBATES, DISCOUNTS, AND PAYMENT TERMS (NET 1–15)
  • UTILIZE GHX PORTAL FOR EDI ELECTRONIC INVOICE PROCESSING
  • PROVIDE MENTORSHIP TO JUNIOR PROCESSORS AND SUPPORT CONTINUOUS IMPROVEMENT
  • MANAGE EXPENSE REPORTS, ELECTRONIC PAYMENTS, AND NON-PO INVOICE PROCESSING
  • PROCESS REIMBURSEMENTS THROUGH INFOR XM
What we offer
What we offer
  • competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage
  • 401k plan that includes a company match and is fully vested after you become eligible
  • paid time off, sick time, and paid company holidays
  • Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching
Read More
Arrow Right
New

Accounting Clerk

We are looking for a detail-oriented Accounting Clerk to join our team in Bakers...
Location
Location
United States , Bakersfield
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 3 years of experience in accounting or a related role
  • Proficiency in accounts receivable (AR) and accounts payable (AP) processes
  • Strong knowledge of QuickBooks and other accounting software
  • Exceptional attention to detail and accuracy in data entry
  • Ability to process invoices efficiently and with precision
  • Solid understanding of journal entries and bank reconciliations
  • Effective organizational and time management skills
  • Associate degree in accounting, business, or a related field preferred
Job Responsibility
Job Responsibility
  • Process accounts receivable transactions, including invoicing and payment tracking
  • Handle occasional accounts payable duties, ensuring accurate and timely payments
  • Maintain and update accounting databases to ensure data integrity
  • Record journal entries and assist with general ledger maintenance
  • Reconcile cash receipts and bank accounts to ensure financial accuracy
  • Review and process invoices, verifying details for completeness and accuracy
  • Perform data entry tasks to support accounting operations
  • Collaborate with team members to ensure seamless financial workflows
  • Utilize QuickBooks for managing and tracking financial activities
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
Read More
Arrow Right
New

Cook

Hartwell Lodge Care Home in Fareham is looking for an experienced Cook or Chef t...
Location
Location
United Kingdom , Fareham
Salary
Salary:
12.72 GBP / Hour
bucklandcare.co.uk Logo
Buckland Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Several years of experience in hospitality/catering is required
  • Level 2 Food & Hygiene is required
  • A City & Guilds Catering qualification would be ideal but is not a requirement
  • Passionate about food, local produce and fresh ingredients
  • Good level of English
  • A good team player
  • Excellent time management skills
  • Prioritising resident and relative needs and offering personalised menus when required
  • Honest and kind person who can work under pressure
  • Previous experience in a care home is beneficial
Job Responsibility
Job Responsibility
  • Work to create inspiring mealtimes for residents at the home, catering to all preferences and dietary requirements
  • Enjoy interacting and communicating with the elderly as there will be regular contact with our residents
  • Have up to date knowledge of food health and hygiene
  • Knowledge on fortified diets and soft diets, but we can train you on this if need be
Read More
Arrow Right
New

Occupational Therapist

Inabia is seeking an experienced Occupational Therapist to join its Rehab Therap...
Location
Location
United States , Robert Lee
Salary
Salary:
Not provided
inabia.com Logo
Inabia Solutions & Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Active Texas Occupational Therapist license (required)
  • SNF experience preferred
  • No new graduates (experience required)
  • Strong documentation, communication, and patient-care skills
Job Responsibility
Job Responsibility
  • Evaluate patients’ functional abilities related to ADLs, mobility, cognition, and safety
  • Develop and implement individualized occupational therapy treatment plans
  • Provide skilled therapy services in accordance with physician orders and facility protocols
  • Educate patients and caregivers on adaptive techniques and equipment
  • Monitor patient progress and adjust plans of care as needed
  • Document evaluations, daily treatments, and discharge summaries accurately and timely
  • Collaborate with interdisciplinary team members to support patient outcomes
What we offer
What we offer
  • Consistent weekday daytime schedule
  • Manageable patient caseload
  • Opportunity to work in a focused SNF rehab environment
  • Supportive interdisciplinary team
  • Fulltime
Read More
Arrow Right
New

Materials Attendant

This job description indicates the general nature and level of work expected of ...
Location
Location
United States , Aurora
Salary
Salary:
19.80 - 29.70 USD / Hour
advocatehealth.com Logo
Advocate Health Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Graduate
  • No experience required
  • Ability to operate and understand basic computer functions, data entry systems and devices
  • Must be able to stand and walk for extended periods of time, have ability to lift, bend, squat, and twist the majority of the workday and crawl, kneel, and climb throughout
  • Must be able to lift up to 15 lbs. from floor to overhead
  • Must be able to lift up to 50 lbs. from floor to waist
  • Must be able to lift and carry up to 50 lbs. at waist height a reasonable distance
  • Must be able to push/pull with 20 lbs. of force
  • Operates all equipment necessary to perform the duties of the job including but not limited to data entry into Material Management Computer System, data entry into hand-held computers, operation of material handling machinery (i.e., Reach trucks, order pickers, pallet movers)
Job Responsibility
Job Responsibility
  • Receives incoming materials and equipment and inspects/verifies the accuracy and the condition of the items before signing for the delivery
  • Ensures efficient and accurate record-keeping systems to verify receipt, storage and distribution of supplies and equipment
  • Prepares, distributes and transports supplies and equipment for safe and appropriate distribution to facilities, departments, or other entities as required
  • Provides for the timely distribution of all supplies and equipment in response to issue requisitions, customer requests, defined replenishment schedules and purchase orders
  • Warehouses and maintains inventory levels and performs issues and credits for supplies and equipment as necessary
  • Replenishes and maintains specialty carts, trays and kits (Code Carts, Isolation Carts, Lime Trays, etc.) checking for outdated supplies as necessary
  • Ensures proper preparation, packaging, initiation of return, and any required follow-up to returned material to vendors as instructed by appropriate documentation
  • Maintains security, orderliness, and cleanliness in all working areas while providing for the continual checking, rotation and removal of outdated and/or damaged materials
What we offer
What we offer
  • Paid Time Off programs
  • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
  • Flexible Spending Accounts for eligible health care and dependent care expenses
  • Family benefits such as adoption assistance and paid parental leave
  • Defined contribution retirement plans with employer match and other financial wellness programs
  • Educational Assistance Program
  • Parttime
Read More
Arrow Right
New

Lawson Senior Accountants

The Senior and Staff Accountants are responsible for performing core accounting ...
Location
Location
United States , Houston
Salary
Salary:
70.00 USD / Hour
medasource.com Logo
Medasource
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Accounting (from accredited university
  • non-negotiable)
  • 5–7 years of accounting experience for senior-level roles
  • 2–4 years of experience for the Accountant II-level role
  • Strong Lawson (Infor) and Excel skills required
  • Experience with Blackline preferred
  • Healthcare industry background a plus, not required
  • Strong analytical, organizational, and communication skills
  • Local preferred, remote/hybrid considered
Job Responsibility
Job Responsibility
  • Prepare and post journal entries in Lawson
  • Perform monthly and quarterly reconciliations in Blackline
  • Conduct variance analysis and ensure timely month-end close
  • Assist with quarterly and year-end audits led by EY
  • Support financial reporting deliverables and internal controls
  • Partner with the ERP project team on data validation and reporting accuracy as needed
  • Maintain process documentation and compliance with internal standards
What we offer
What we offer
  • Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage
  • 401k plan that includes a company match and is fully vested after you become eligible
  • Paid time off, sick time, and paid company holidays
  • Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching
Read More
Arrow Right