Twenty year CQA professional with experience in both Quality Systems and Regulatory Affairs.  Excellent Audit, Validation, Compliance and Design Control background in the Medical Device and Pharmaceutical industries.

Titles Held: Senior Consultant; Director of Quality Assurance; Project Manager

• Excellent international experience: Created several Technical Files and Design Dossiers for the EU, packages for licensing on 6 continents including Canadian License and obtaining Japanese shonin.
• Submittal experience with INDs, IDEs, 510Ks, 510Ks with clinical, PMAs, 1 BLA, 1 HDE, CBE-30s and pre-approval supplements (PAS) for CMC changes to approved products
• QA Validation: Heavy Design Control background; QA review of Testing Protocols and Final Test Reports to assure compliance with applicable standards and regulations
• Strong audit experience with both Internal and External Audits; OEM’s, manufacturers; clinical study sites; sterilization facilities to name a few
• Exceptional Technical Writing skills as well knowledge of Regulations and Guidelines: cGMP, cGCP/ICH, cGLP, QSR, ISO 13485:2003, MDD (all Annexes), HIPAA, 21 CFR Part 11, HACCP, Canadian Regulations, ANSI/AAMI