Ruthann R. DePietro

PO Box ***

Atkinson, NH ****1

Cell 978-***-****

Email: ad3czp@r.postjobfree.com

Ruthann DePietro LinkedIn- www.linkedin.com/in/ruthann-depietro-6b03316/ Summary

Senior Executive, with significant background in the Medical Device and Invitro Diagnostic Industries. Experience in large multi-functional organizations, small start-ups, and contract ventures. Career path has included R&D, Manufacturing Engineering and primarily Quality/Regulatory/Clinical. As a corporate officer, participated in acquisition considerations and sales of companies. Assisted with the development of foreign supplier networks, including the preparation of necessary regulatory requirements. Experience bringing companies global from manufacturing to selling and distribution. Regulatory includes EU MDR & IVDR, upgrading or identifying Notified, England UKCA, China NMPA, Korea KFDA, Japanese PMDA and other worldwide regulations and changes. Business Experience

RDR – DePietro Consulting, Atkinson NH Founder and Director of Quality, Regulatory and Compliance. Newly initiated Consulting Business. Supported a Medical Device Start-up Company with the EU MDR process. Instrumentation Laboratory, Co., Bedford MA, Private Barcelona owned company that designs, develops, and manufactures worldwide. The company is the world leader or second in Hemostasis, and also very strong in Acute Care in multiple technologies. Operating Income has been very strong and the company has accomplished $1billion in sales in 2021.

Vice President of Quality / Regulatory/ Clinical 2012-2023 Managed worldwide Regulatory audits. Responsible for Quality Assurance and Regulatory / Clinical Affairs Departments. Responsible for MA, NY, SD and Munich Sites. Reorganized the departments within Quality and Regulatory to be more focused and efficient. Directed the activities for Worldwide Compliance and registrations. Part of local and global teams for strategic decision making. Responsible for Due Diligence and acclimation of the acquisitions in SD and Munich. Exceeded $1 billion in sales worldwide. Oversaw FDA, ISO 13485, IVDR, Korean, China and other worldwide Regulatory bodies. Introduced Risk Management Culture to the company. It is utilized in Product Development, Post Market support, Quality / Regulatory Systems, and interactive systems for decision making for all business decisions. Insulet Corporation, Bedford, MA, Public company that designs, develops, manufactures and sells a unique wireless and tubeless insulin delivery pump. The company has grown from a 10% gross margin to a 50% gross margin in five years and from 50 customers to 30k customers in the same timeframe with over $30 million in revenue. The company is pursuing multiple applications for drug delivery with large pharmaceutical companies. Vice President of Quality / Regulatory/ Clinical 2006-2012 Responsible for the Quality Assurance and Regulatory/ Clinical Affairs Departments. Directed the activities for global registrations, regulatory clearances and licenses including FDA, ISO, CE Mark, South America, China, and the Middle East.

Developed the Quality Manual and continue to improve and streamline the Quality System, including implementation of a paperless system that integrates all functions, and international suppliers. Worked closely with the FDA through multiple submissions and clinical studies during multiple pump regulation and blood glucose regulation changes. Have been on the leading edge of Human Factor trial development and Closed-loop studies with the JDRF and FDA.

Developed a unique and manageable Complaint Handling System based on risk and volume which has withstood the scrutiny of the agency.

Managed multiple FDA Inspections for QSIT and cause with positive outcomes. Have focused the organization on Quality Improvement and Design Assurance through clearly defined goals, objectives and metrics.

Instrumental in contributing to product, process and system improvements, including leading significant activities to transfer Manufacturing to Asia.

Key contributor to Business Development Activities with strategic partners. ONUX Medical, Inc., Hampton, NH, Venture backed company that designed, developed, manufactured and sold laparoscopic suturing and fixations devices and accessories for general surgery, plastic surgery, cardio and cardiovascular products. The business grew from zero sales to a $12 million run rate before executing the exit strategy.

Vice President of Quality / Regulatory 2000- 2005

Responsible for the Quality and Regulatory Department. Directed the activities for FDA, ISO, CE Mark Certifications, and other international regulatory requirements. Developed the Quality Manual and Quality Management System for the organization.

Participated in Sales training and interfaced with the customers on product development and product support activities.

Chaired the Operations Strategy Committee with a focus on cost reduction, planning, new product scheduling, and equipment/staffing requirement forecasts.

Established product and process validation activities and managed the Design Control Process. Instrumental in contributing to product, process and system improvements. Key contributor in evaluating new clinical applications for existing or modified product. Earlier Roles

• 1996-2000 Micro Med, Inc. / Disetronic, Portsmouth, NH, Contract Manufacturer of medical devices related to infusion sets, arthroscopy, orthopedic, urology, cardio, and insulin delivery products. The business grew from $5million to $10 million. Responsible for the Quality / Regulatory, Design Transfer and Engineering departments. Directed the activities for FDA, ISO, and EN Certifications and managed multiple CE mark related audits for our customers.

• 1995-1996 Bard Vascular Systems, Division of C.R. Bard, Inc., Haverhill, MA, Developer and manufacturer of grafts, mesh, Oxygenators, Blood Pumps, and other related cardiovascular and cardiopulmonary products. Responsible for Design Assurance, QC, Engineering, Calibration, Complaints and Lot Release. Harmonized Quality Systems of two divisions for two diverse product lines.

• 1994 -1995 Bard Interventional, Division of C.R. Bard, Inc., Tewksbury, MA, Developed and manufactured endoscopic medical devices. Independent Quality System Consultant. Responsible for Quality System development, implementation and training related to Design Assurance and Laboratory Practices. The implemented systems obtained an “A” rating from the Corporate Audit Function.

• See Full Resume for more information. Resume v5. Education

Northeastern University High Tech Business M.B.A.

University of Rochester Polymer Chemistry B.S.