Natalya L. Koshnitsky
Wellesley,MA
Summary
Strategic-thinking leader with over 20 years of hands-on Quality and Regulatory experience within start-up, mid-size medical device satellite, manufacturing and contract manufacturing settings. Skilled in ISO13485:2016, 21 CFR 820, EU MDR, MDSAP, M&A, FDA factory inspection readiness, FDA's 483 and warning letter remediation. Obtained and managed commerical licenses in the USA and in 42 countries OUS.
Overview
19
19
years of professional experience
1
1
Certification
Work History
DIRECTOR, QUALITY AND REGULATORY AFFAIRS
NeedleTech Products, Inc.
03.2024 - Current
- Provide strategic leadership in developing quality and regulatory strategy for manufacturing and design sides of the business.
- Interface directly with FDA, notified bodies, customers and other involved parties to drive established quality and regulatory strategies forward.
- Strengthen internal controls by reviewing existing policies and procedures, ensuring continuous compliance with applicable regulatory requirements.
- Lead QMS in accordance with ISO13485:2016, 21 CFR 820, EU MDR and other regulatory and statutory requirements.
- Build strong partnerships with key stakeholders, enabling increased collaboration on problem-solving efforts and overall process improvements.
- Establish clear performance metrics, monitoring progress to ensure continuous improvement in product quality and customer satisfaction.
President & CEO
Device QR Services, Inc.
01.2020 - Current
- Contract with medical device legal and contract manufacturers to accomplish various quality and regulatory objectives, including but not limited to quality system planning and implementation, regulatory strategy, FDA's 483 remediation, and etc.
- Educate and coach personnel on various subjects of quality and regulatory compliance.
- Prepare factories for FDA and notified body inspections.
- Perform pre M&A due diligence.
- Perform internal and supplier audits to ISO9001:2015, ISO 13485:2016, 21 CFR 820, EU MDR and MDSAP requirements.
- Interact with FDA and notified bodies on customer behalf.
BOARD MEMBER
Cavero Coatings
01.2022 - 03.2023
- Provide Quality and Regulatory strategic guidance.
DIRECTOR, QUALITY AND REGULATORY AFFAIRS
Precision Coating Company, Inc.
01.2013 - 01.2020
- Following the acquisition of Boyd Coatings, integrated quality management systems, qualified newly opened manufacturing site in Costa Rica and ISO 13485 certified multiple sites under one QMS umbrella without major findings.
- Lead Quality and Regulatory department across multiple US and Costa Rica plants.
SR. MANAGER, QUALITY COMPLIANCE
Avedro, Inc.
01.2009 - 01.2013
- Implemented electronic quality management and complaints systems.
- Qualified and certified an assembly facility to ISO13485 certification in Ireland and the US.
- Developed and implemented post market surveillance and internal audit teams.
- Managed internal, external and third-party audits and ensured audit readiness.
- Led continuous improvement activities to achieve business and quality objectives and ensure.
- Worked directly with FDA, Notified Bodies and other regulatory agencies to ensure continuous commercialization of products and compliance of the quality management system.
MANAGER, QUALITY AND REGULATORY AFFAIRS
Orbital Therapy, LLC
01.2006 - 01.2009
- Built and implemented QMS.
- Prepared and obtained 510 (k) clearance and CE mark certification.
- Passed an FDA audit without 483 or warning letters.
Education
Program for Leadership Development (PLD) -
Harvard Business School
Boston, MA01.2019
Health Product Regulation (MS) -
Regis College
Wayland, MA01.2010
Communication Studies & Business Administration (BA) -
Vesalius College
01.2003
Skills
- Quality system planning and implementation (ISO13485:2016, 21 CFR 820, EU MDR)
- Auditing (ISO 19011, MDSAP)
- Strategic planning
- Regulatory strategy
- Risk management
- Continuous improvement
- Post market surveillance
- FDA factory inspection preparation
- Lean manufacturing
- Contract management
Certification
- KARA & Associates, Inc., EU-Medical Device Regulation 2017/745 (MDR) Certification, 01/01/19
- MDSAP Companion Document G0002.1.004 based on ISO 13485:2016, RDC 16, 21 CFR 820, 803 & 806, MO. 169 Chapter 2, CMDR SOR 98-282, TGA Regulatory Requirements, 12/19/2019
- ISO 13485: 2016 Training Certification (ASQ Biomedical Division), 01/01/16
- ISO13485: 2003 Lead Auditor (TPECS) Certification (BSI Group), 01/01/13
Timeline
DIRECTOR, QUALITY AND REGULATORY AFFAIRS
NeedleTech Products, Inc.
03.2024 - Current
BOARD MEMBER
Cavero Coatings
01.2022 - 03.2023
President & CEO
Device QR Services, Inc.
01.2020 - Current
DIRECTOR, QUALITY AND REGULATORY AFFAIRS
Precision Coating Company, Inc.
01.2013 - 01.2020
SR. MANAGER, QUALITY COMPLIANCE
Avedro, Inc.
01.2009 - 01.2013
MANAGER, QUALITY AND REGULATORY AFFAIRS
Orbital Therapy, LLC
01.2006 - 01.2009
Health Product Regulation (MS) -
Regis College
Program for Leadership Development (PLD) -
Harvard Business School
Communication Studies & Business Administration (BA) -
Vesalius College
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