Brendan Koren
Boston, MA
*******.*****@*****.*** - 217-***-****
WORK EXPERIENCE
Financial Analyst II
Fresenius Medical Care, Healthcare Services - Waltham, MA - July 2013 to Present
• Leveraged knowledge of company products, services, and processes to obtain analyst position.
• Successfully completed Business Planning and Analysis comprehensive training program
• Responsible for analyzing company wide data and sending succinct meaningful reports to senior
management
• Collected and utilized information to determine the financial feasibility of potential acquisitions, joint ventures,
and start-up businesses
• Evaluated potential new business opportunities by developing proforma income statements, cash flow
statements, and balance sheets and presented results to senior management
• Collaborated with various departments including business development and operations to ensure the
accuracy of the projected financial information.
• Assisted with reviews of the operating performance of completed transactions to review the accuracy of
projections and key assumptions used in the models through variance analysis
Product Complaint Coordinator, Team Lead
Fresenius Medical Care Quality Systems - Waltham, MA - February 2012 to July 2013
• Promoted to Product Complaint Coordinator, Team Lead in less than one year.
• Accountable for all prior listed responsibilities as Clinical Complaint Support Technician
• Demonstrated leadership through complete and efficient training of newly hired staff.
• Execute decision trees to assess complaint reportability to various competent authorities in accordance with
FDA QSR, 21 CFR 820, ISO 9001, and ISO 13485.
• Review all received documentation and patient records and interface with Regulatory Affairs to review and
process complaint data.
• Collaborate on a multi departmental level to develop strategies for overcoming challenges and barriers with
complaint management systems.
• Implement Corrective and Preventative Action (CAPA) measures to modernizes processes and improve
efficiency.
• Prepare reports containing recommendations for senior management regarding strategy development for the
complaint management system.
• Prepare and send correspondence to product end users to obtain relevant information related to serious
alleged product malfunctions, pursuant to 21 FCR 820.198.
Clinical Complaint Support Technician
Fresenius Medical Care Quality Systems - Waltham, MA - September 2011 to February 2012
• Determine if information received meets complaint criteria in accordance with company standard operating
procedure and 21 Code of Federal Regulations 820.198 pertaining to Quality System Regulation.
• Responsible for entering complaints in a timely manner so as to conform to federal reporting requirements
and company procedures.
• Investigate alleged complaints through interviews with patients, nurses, and others familiar with complaint
situations to gather adequate information for claim processing.
• Interface with customer service, technical service and manufacturing facilities to gather additional information
required for complaint investigations.
• Properly document newly gathered information to ensure compliance with current Good Documentation
Procedures and FDA regulations (i.e. ISO 900121 and CFR 820).
• Ensure information is documented in a way that all audiences can understand.
• Review manufacturing facility investigation to ensure accuracy and completeness.
• Review complaints prior to closure to ensure all necessary data is present.
• Close complaints in the complaint management database following successful investigation and
documentation in the complaint record of all stakeholders (i.e. manufacturing, RA, Clinical Analysts).
Resident Advisor
St. Ambrose University, Residence Life Department - Davenport, IA - August 2009 to May 2011
• Fostered community among fifty-six traditional housing (underclassman) residents of the floor with another
Resident Advisor by facilitating conflict resolution; planning programs; confronting; responding to and
documenting inappropriate behavior/ violations of university policy.
• Actively participated in interviewing and evaluating Resident Advisor candidates.
• Acted as a liaison between Residence Life and residents, and worked with other staff members.
• Participated in training and professional staff development.
• Counseled students one-on-one, academically, socially, and emotionally.
EDUCATION
Master of Business Administration
Boston University - Boston, MA
2012 to 2015
BA in Accounting, Marketing, & Management
Saint Ambrose University - Davenport, IA
2008 to 2011
ADDITIONAL INFORMATION
1.Certified Six Sigma Green Belt.
2.Graduated with honors from St. Ambrose University within three years with a Bachelor’s degree in
Accounting, Marketing, and Management.
3.Working toward a Master’s of Business Administration Degree from Boston University
4.Knowledgeable in the areas of negotiation, supply chain management, project management, and financial
management.
5.Demonstrated analytical approach to solving complex problems through the application of sound judgment
and leadership abilities