- 1354 104^th Ave NW Ÿ Coon Rapids, XXXXXX xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

Regulatory Affairs Specialist ▪ Senior Quality System Specialist

Qualifications Profile

    Self-motivated, dynamic, and results-driven solutions provider in the fields of regulatory compliance, and quality systems management with more than 24 years providing outstanding, high-performance, high-visibility technical customer service, and operations support in the technology manufacturing and healthcare industries.

-    Proven dedication to process efficiencies in quality systems management and regulatory compliance that ensures product quality and service consistency in target markets

-    Detail-oriented, analytical and methodical with critical thinking to resolve issues in process validation, quantitative and qualitative systems analysis, and medical device quality system regulations.

    Well-organized and resourceful with multitasking skills that optimize limited resources to achieve outstanding results.

    Strong people management and interpersonal communication skills that inspire confidence across diverse ethnicities.

Key Expertise

Business Operations Management

    Customer Service Management

    Technical Service Support

    Lean Manufacturing

    Project Management

    Total Quality Management

    Process/Workflow Improvement

    Relationship Management (Clients, Stakeholders, & Suppliers)

    Statistical Quality Control

    Inter-Office Coordination

Administration

    Policies & Regulatory Compliance (i.e. FDA, cGMP, GLP, ISO, CFR Parts 160 & 164, CFR 210/2011, 820, 803, 806, etc.)

    Staff Supervision & Training

    Records & Document Management

Technical

    Apps: SPSS, FACTORYworks, JDE, LIMS, ELN, DART- Seibel, & Global Complaint Handling

    OS: MS Windows

    Productivity Tools: MS Office (Word, Excel, PowerPoint, Access, & Outlook)

Professional Experience

Medtronic Corporation Rice Creek, XXXXXX

Ÿ Receive and assess customer feedback and complaints to assess compliance issues, documenting gathered information in the Global Complaint Handling (GCH), evaluating complaint for needed information, and initiating efforts to gather data from Field Personnel, Health Care Providers, Patients and other initial reporters.

Ÿ Oversee compliance to established quality system, reporting on conformance issues to Senior QA leadership with recommendations on resolving problems and improving quality control processes.

Ÿ Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.

Ÿ Generate complete regulatory reports for timely submission to FDA and other regulatory agencies, assisting management in monitoring and coordinating follow-up audit activities in conducting internal and regulatory agency audits, and inspections.

Ÿ Serve as resource person in addressing quality compliance issues, coordinating with cross functional departments in implementing remedial measures to correct non-compliance issues identified in internal/external audits

Ÿ Conduct investigation of non-compliance incidence as needed, determining potential cause and contributing factors to the alleged event as well as device relationship, summarizing and presenting investigation results to management.

Ÿ Collaborated with business partners including Patient and Technical Services, Field Sales, Marketing, Product Development, and other areas of the business to complete complaint investigations and make reporting decisions.

Ÿ Ensure compliance with all applicable FDA regulations, specifically 21 CFR Parts 820 and 803, escalating complex non-compliance issues to management.

Medtronic Inc. Fridley, XXXXXX

Ÿ Evaluated and documented comments and complaints on all Neuromodulation products in accordance with regulatory standards, applying policies and procedures, and interacting with patients, medical professionals, and sale representatives in obtaining critical information to ensure compliance with quality system regulations and withstand FDA and TUV investigation.

Ÿ Worked with relevant Regulatory Affairs leadership in addressing regulatory shortfalls, supporting enforcement of remedial measures to products, services, and processes to resolve future regulatory issues.

Ÿ Produced FDA submissions involving product changes that ensured approvals for timely market releases.

Ÿ Initiated quality monitoring programs that reduced manufacturing errors from 90 errors/week to 4 errors/week.

Ÿ Collaborated with business partners including Patient and Technical Services, Medical Device Reporting, Product Performance, Field Sales, Marketing, Product Analyst, Repair Technicians and other areas of the business to ensure collection of complaint information in an efficient and customer focused manner.

- 1354 104^th Ave NW Ÿ Coon Rapids, XXXXXX xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

Professional Experience (continued)

Medtronic Corporation Brooklyn Center, XXXXXX

Ÿ Collaborated with engineers in preparing a foaming electrolyte for development consumption, including preparation of DADET hardener, epoxy kits, and polyurethane adhesive solution for MCRD, organizing and maintaining inventory of all chemicals and laboratory equipment,

Ÿ Served as Team Lead in synthesizing a high purity organic compound called Amino Oleic Acid (AOA) used to treat tissue valves to prevent calcification, successfully developing and executing processes that drove 40% increase in chemical production yield of Amino Oleic Acid Synthesis.

Ÿ Partnered with engineers to formulate foaming and working electrolyte for Medtronic Mexico, assisting in setting up reactor facilities in Mexico for production operations.

Education & Credentials

Ÿ M.S. in Regulatory Affairs for Drugs, Biologics, & Medical Devices

NORTHEASTERN UNIVERSITY Boston, MA

Ÿ Master of Healthcare Administration

DES MOINES UNIVERSITY, College of Osteopathic Medicine and Health Sciences Des Moines, IA

Ÿ B.S. in Finance, METROPOLITAN STATE UNIVERSITY St. Paul, XXXXXX

Ÿ B.S. in Chemistry, UNIVERSITY OF MINNESOTA Xxxxxx, XXXXXX

Professional Affiliations

Member:

Ÿ Regulatory Affairs Professional Society (RAPS)

Ÿ American Society of Quality (ASQ)

Ÿ American Chemical Society (ACS)