Janet Kwiatkowski has over 15 years of Regulatory Affairs and Compliance leadership and experience at Fortune 500 and start-up companies. Janet is experienced at developing and successfully implementing global regulatory and compliance strategies for medical devices, in vitro diagnostic devices and import and export trade compliance strategies aligned with business and marketing plans. Product portfolio includes Class I, II and III medical devices, companion diagnostics and combination products. Medical specialties include electrical-mechanical systems, disposables, assays in areas including but not limited to cardiovascular, gastroenterology, radiology, obstetrics/gynecology, general and plastic surgery, hematology and immunology.
She has also led organizational transformations, successfully cultivated international business markets through regulatory affairs, and created and conducted leadership and diversity training programs. Janet also has engineering, operations and business development expertise.
Janet holds Associates of Science Degree in Computer Electronics, Bachelor of Science Degree Mechanical Engineering, Master of Business Administration and Master of Science Degree in Regulatory Affairs for Drugs, Biologics and Medical Devices.
Yashesh Rawal has over 3 years experience in global regulatory affairs in medical devices and quality management system. Yashesh has experience in writing 510(k) submissions, IDE submissions, IRB submissions for Class II and III medical devices as well as experience in GLP and GMP requirements. Medical specialties include electrical-mechanical systems, disposables, assays in areas including but not limited to neurology, cardiovascular, gastroenterology, radiology, general and plastic surgery, general surgery, and hematology.
He also has regulatory experience in biologics, nanotechnology and drugs including development of protocols for pre-clinical and clinical activities, batch formulations, and drafting and implementing procedures in support of anti-cancer drugs and nanostructured lipid molecules loaded with siRNA.
Yashesh holds Bachelor of Science Degree in Pharmacy and Master of Science Degree in Regulatory Affairs for Drugs, Biologics and Medical Devices.
MAE Consulting Group has a vision. Steve Ives develops strategies to achieve that vision. Steve has more than 25 years of experience helping emerging companies achieve rapid growth. That begins with developing a laser-focused strategy, the subsequent tactics, and executing on those tactics. The only one true measure of success is revenue, which Steve is responsible for.
Steve has a wealth of experience working with companies that have created sophisticated solutions using complex development processes. The med-tech community offers state-of-the-art solutions build on best practices. Regulatory compliance is the ability to document and publish what they are already doing in a meaningful manner.
Steve holds a BSEE from the University of New Hampshire and is a licensed professional engineer in the State of New Hampshire.
Regulatory and Compliance Leadership
- Built and submitted dossiers for multiple medical and in vitro diagnostic devices for global markets such as EU, Brazil, China, Taiwan, Japan and Canada.
- Product experience includes cardiovascular, obstetrics/gynecology, gastrointestinal/urology, general and plastic surgery, radiology, immunology, hematology and microbiology medical devices and in vitro diagnostic devices.
- EPA FIFRA (Federal Insecticide, Fungicide and Rodenticide Act) labeling and registration of over 100 pesticide classified products for a fortune 500 company for products imported into the United States.
- EPA LVE and PMN applications for Flurosurfactant products for a fortune 500 company based in Germany.
- Managed Foreign Trade Zone for a Fortune 500 company, ensure compliance with Harmonized Tariff Schedules, proper filings to government agencies, foreign trade agreement requirements, developed program to comply with deemed exports, managed with outside counsel, voluntary self disclosures to government agencies.
- Led premarket activities such as design and process reviews, verification and validation activities, worked with marketing and business teams to develop global regulatory strategies.
- Led post-market activities such as adverse event filings, recall management, vigilance reports, compliant resolution and root cause analysis and negotiate with government agencies.
- Co-Led development and market activities for RF generator, developed regulatory strategies to meet marketing launch plans.
- Developed and marketed disposable probes such as Argon probes, snare probe, multi-electrode probe and Bipolar adapters.
- Led International RA/TC Conference to build team relationships with each member presenting overall responsibility.
- Identified core competencies for the team to recognize and utilize for daily responsibilities and project assignments within the company.
- Developed goals and objectives aligned with business plans and strategically partner with multiple international business units.
- Developed business plan to identify and assist international medical device companies gain FDA clearance and enter US commerce.
- Promoted regulatory as a revenue generating activity for business growth with international companies.
- Awarded State Trade and Export Promotion Grant Program (STEP) to assist company to enter and succeed in the international marketplace.
- Managed over 20 projects simultaneously through acquisition related to regulatory affairs, trade compliance, merger and acquisition plans, organizational structuring, re-branding and other business related projects.
- Successfully managed regulatory and compliance effort to transfer in-house distribution to a centralized 3PL.
- Successfully launched Argon Plasma Coagulation device for endoscopic use from a single platform in the US and EU within budget and time constraints.
- 510(k) Dossiers
- International Dossiers
- Biologic Master File
- Device Master File
- Radiation-Emitting Product Reporting
- LVE, PMN Applications
- FIFRA Compliance
- Cosmetic/Drug/Biologic Regulations
- Device Classification and Lead Agency Determination
- Internal Audits
- Due Diligence Audits
- Waning Letter Response
- Recall Management
- Voluntary Self Disclosures
- Deemed Exports
- FTA Assessment
- FTZ Management
- Dual-Use Assessment