I have free and open conversations with individuals from all areas of the business in order to clarify the regulatory requirements and enable the business to implement compliant and lean solutions. I manage a team of 6 that are responsible for Document Control, Records, Pre and Post-Market Risk Management for Product and Process, Product and Process Change Management, Event Reporting and CAPA/Continuous Improvement. As a senior leader on the Q&R leadership team, I am active in budget creation, team restructuring, joint venture work with our China group, career development and mentoring. I have responsibility for the successful implementation of the EUMDR requirements in the Accuray Quality system. To achieve this, I project manage a team of 15+ people to close the Gaps identified in the Quality System against the Articles and Annexes. I execute the responsibilities of PRRC and conduct Management Review. I run the Backroom for all Audits and am a Front Room Subject Matter Expert for all audits of the Quality System (MDSAP, ISO 13485 and international assessments).

My strengths are in the creation and implementation of systems, evaluating a system’s impact on other areas, organizing and assessing data for submissions, and interpreting the needs of Quality Assurance/Regulatory Affairs to a software developer, another department or an implementation team. I was responsible for a team of 7 individuals. Q&R management activities including budget planning, succession planning, career paths, improving training programs and a mentoring program. In an effort to be a better executive leader, I completed the RAPS sponsored Executive Development course: Kellogg II at Kellogg School of Business.I have flawlessly performed in multiple FDA inspections, multiple Notified Body Surveillance audits, Notified Body recertification inspections with no observations.I shaped the regulatory strategy for the product line and maintained Global Product Registration process, (including submissions to register product in multiple foreign countries including Singapore, Thailand, China, Korea, Japan, Russia and Brazil) submitting 510(k)s and Technical Files. I managed post market compliance team whose activities included the submission of MedWatch, C & R reports, Health Canada and other international compliance reports.I am adept at change management using Agile Software PLM process; I also served as the Regulatory Affairs team member for a major outsourcing project. I generated, facilitated, and executed CAPAs, reviewed changes for effectiveness, and monitored the CAPA system. I created and implemented numerous process/procedure improvements within the Quality System.

I designed, programmed and implemented websites for small companies, specializing in corporate presence web sites. I utilized HTML programming with some JAVA and ActiveX programming elements. This position utilized project management and communication skills. I also had to identify customer needs and requirements.

Regulatory Affairs SpecialistInstrumental in achieving ISO 9001 certification and evaluating impact of ISO 9000:2000.Directed the documentation required for the import & export of products (destinations & origins include the European Union and Australia).Created & managed documentation and record systems supporting the Quality System.Completed training in QSIT and electronic document management.Supervised team of individuals during ISO conversion process.Evaluated and implemented software systems regarding documentation and data tracking for ISO and GMP records.Refined electronic documentation systems and manual archival systems.Member of the Institutional Biosafety Committee.Member of the Quality Management Core Team.Created and performed training on the documentation and records systems.

Standard Operating Procedure CoordinatorCreated NDAs, ANDAs, and first batch records for submissions, also created and submitted addenda to existing NDAs. - Drug therapies submitted include: Pancreatin, Heparin, Myloral (clinical & pre-clinical), and Onconase (pre-clinical). - Lead team for Pancreatin & Heparin NDA submissions. - Team member for Myloral & Oconase INDA & ANDA submissions. - Solo for the update to the Pancreatin NDA.Compiled and submitted the FDA’s annual report.Managed and maintained the documentation systems for this bulk pharmaceutical manufacturer.Created standardized language for safety information within documentation.Developed methods for the retention and maintenance of training records. Quality Control ScientistPerformed Quality Control testing on bulk pharmaceutical products; validation studies on various systems and instrumentation; created and updated procedures and training within the laboratory.