Regulatory Specialist Resume Sarasota, Florida - Hire IT People

SUMMARY:

Results - oriented Senior Quality Professional with extensive medical device experience designing and developing quality assurance and controls for enhancement of manufacturing processes.
Effectively coordinates team efforts in the development of programs in regulated industries.
Build across-the-board partnerships with business, marketing and technical teams, as well as management, and strategic partners throughout product development. Skilled at determining the need for change and effectively introducing change into existing infrastructures. Performed root cause analysis
Thorough knowledge of ISO13485| Part 211 | ISO13485 and 21 CFR Part 820 Lead Auditor | Supplier Auditor | Quality Management Systems implementation, execution and maintenance | Leadership and Team Building | Performance Management | Trouble Shooting | Product Yield Improvement | User and Support | Vendor Management | Process Improvement | Key Stakeholder Relations | Strategic Planning | Product Development | Green Belt Certified | Expertise in Effectiveness and Competency | Project Management

TECHNICAL SKILLS:

Skills: Microsoft Word, Excel, PowerPoint, Project, Visio | Articulate Storyline | Minitab | TrackWise | SmartSolve

PROFESSIONAL EXPERIENCE:

Regulatory Specialist

Confidential, Sarasota, Florida

Responsibilities:

Coordinated foreign registration information for countries in Asia, South America, Middle East and Europe Prepared of Foreign Government (CFGs) for worldwide countries and coordinated with the FDA and the US State Department for appropriate apostille s Reviewed CAPA effectiveness

Quality Systems Specialist-Contractor

Confidential, Minneapolis, MN

Responsibilities:

Quality Engineer

Confidential, Minneapolis, MN

Responsibilities:

Learning Management System Integration evaluation Suggested $750,000 of cost savings for redesign

Sr. Quality Engineer

Confidential, Minneapolis, MN

Responsibilities:

Integration of the Learning Management System (IsoTrain) between corporate and the local affiliate Streamlined requirements to maximize cost savings Resolved and completed reports for product complaints CAPA resolution

Quality Systems Specialist

Confidential, Minnetonka, MN

Responsibilities:

Managed the Internal Audit Program and served as lead auditor Hosted BSI audits and external auditors Managed the technical system Defined effectiveness and competencies Managed the Document Control System Managed Supplier Qualification program Evaluated, qualified and continuously monitored supplier performance Designed and delivered Quality Systems Onboarding and Annual Quality Compiled Design History Files and Device Master Records Assisted with 510K reviews Responsible for Quality Objectives regarding compliance Top wellness exercise enthusiast for seven consecutive months

Quality Systems Specialist

Confidential, Plymouth, MN

Responsibilities:

Product release and batch record review Reviewed and approved labeling Completed internal and external supplier audits Investigated product complaints Designed and delivered CGMP and Good Documentation Practices GFSI interaction SQF Auditor ISO 17025 Auditor

Sr. and Specialist

Confidential, Plymouth, MN

Responsibilities:a

Managed the corporate wide program and Confidential program Determined competencies for the Learning Management System Assisted with the IQ, OQ, PQ of the Learning Management System Participated in the audit steering committee Designed and developed using the ADDIE method Managed Quality System Onboarding and Annual Quality for all staff

Quality Associate III

Confidential, Brooklyn Park, MN

Responsibilities:

Managed the corporate wide program Participated in internal audits Reviewed batch records