Medical Device Regulatory Affairs

Donna Djinovich

*** * ******* ****** *** ***

Chicago, IL 60654

Phone: 847-***-****

*****.*********@*****.***

Expertise:

· Regulatory Affairs Certification MDSAP

Regulatory Strategy Development Technical Document Reviews

Regulatory Assessments European Medical Device Regulation

510K and PMA Submissions Risk Management

Clinical Evaluation and GxP/GLP Combination Products

Complaints Evaluation FDA/Health Canada/Latin America Compliance

CAPA (DMAIC) Quality System Regulation

Quality System development Advertising and promotional labeling

International and Domestic Product Approval European IVDR EU 2017/746

Product Development DeNovo

Risk Management Investigational Device Exemption (IDE).

IND/NDA/ANDA knowledge Global product standards

Cross Functional Team Leadership UDI regulation

FDA Direct Communication Kidney Dialysis Equipment

Cardiovascular Product Knowledge Diagnostic Point of Care and other IVD products

Respiratory equipment product knowledge Vision Care Product Knowledge

Neonatal Medical Devices Change Control

Design Control Medical Device Manufacturing

Breast Implants Electromechanical Equipment

Software as a stand alone medical devices Medical Device Software

Training and Mentoring Regulatory Professionals

EDUCATION & CERTIFICATIONS

B.S. Environmental Health Science - Purdue University/Indiana State 1994

M.B.A., Marketing --- Benedictine University

Graduate Certificate, Quality and Regulatory Science Purdue University - RAC – Regulatory Affairs Certified.

Langue Skills: Work Eligibility:

French Language Proficiency US Citizen

Serbian/Croation/Bosnian/Montenegrin fluency European Union

Some Russian

Principal 2016 to present

DD Global MedDev Consulting LLC

Quality and Regulatory consulting for the life science industry including the following services:

Personal Client List and Task

Past Customer

Company and Responsibility

Task

Start Date

Establishment Labs Costa Rica: Manufacturer of Class III breast implants.

(General QA/RA consultant)

Performed regulatory function as Sr Director of RA in order to prepare organization for eventual US launch.

Established organizational processes, hired employees to fill critical roles in the RA organization including direct communication with the FDA. Contributed to IDE processes by serving as an expert reviewer of both PMA and IDE which included a clinical study of 500 patients in the US. Prepared employees for FDA inspections.

9/2019 – 03/2020

mmHG, Inc., Edmonton, Canada: NPD Blood Pressure Monitors with WiFi capability.

(General QA/RA consultant)

Regulatory and Quality Consultant for Canadian Start-up with 8-10 employees. Regulatory Strategy resulted in developing the Quality System from scratch and drafting of 510k for the Class II ambulatory blood pressure monitor including development of a software application intended to transfer blood pressure data from the blood pressure device to remote clinical operations.

07/2017 – 02/2024

Opternative, Chicago Illinois.

Design of New Product (on line eye exam)

(General QA/RA consultant)

Regulatory and Quality Consultant for Start-Up with 35 employees. Developed regulatory strategy for the DeNovo path that includes an innovative on line eye test. DeNovo application included developing a clinical and human factors strategy involving a clinical study requiring 100 patients. Successfully organized a meeting with FDA Opthamology Division advisory board to gain concensus and feedback pertaining to completion of clinical study and DeNovo Application. The meeting with the FDA resulted in permission to market the product while under the DeNovo application status pending completion of the clinical and human factors according to the timeline.

09/2016-9/2018

Altek, CostaRica -medical device manufact.

US FDA Agent

ongoing

Past customer

Company and responsibility

Task

Date

Philips, Bothell WA.

NPD of Class III EKG Defibrillator: Senior Regulatory Consultant

ALKU Staffing

Developed a Regulatory and Clinical Strategy for Class III PMA device. The strategy was developed to cover domestic and international markets for the Cardiovascular device. Initiated writing the PMA for Class III PMA device. Evaluated changes to Class III products and submitted supplements and annual reports to the FDA and Notified Bodies. Remediated Tech Files according to the MDD and MDR regulation for CE marked Class III and Class II devices.

9/2018-11/2019

Bausch Inc. – Senior Regulatory Consultant

ALKU Staffing

Evaluated technical data for Intraocular lenses for inclusion into the PMA supplements.

Provided input and writing of 510k for topical analgesic.

01/21-5/20/21

Johnson and Johnson, Eye Care Division

Senior PMA consultant: MDR/EUDAMED remediation.

REAL Staffing

Project manager for EU MDD to MDR transition specifically EUDAMED UDI program for Surgical Products Business Unit.

05/22-6/23

Natus, Seattle, Washington.

Senior Quality System Consultant for Quality and regulatory processes. Contracted for Bioteknica

Assisted a Class I/II/III medical device manufacturer of neonatal infant products in Seattle, WA to remediate their Quality System deficiencies as outlined in a Warning Letter issued by the FDA in 2016. Specific tasks included improving Regulatory Affairs processes that outlined evaluation of changes to determine impact on regulatory submissions worldwide. Remediated Design History Files pertaining to product marketing claims and 510k submissions. Developed and improved client’s Field Corrective Action Processes.

09/2017 – 7-2018

Vyaire, Lake Forest, Illinois

Contracted for Bioteknica consulting.

Served as Director of Regulatory Affairs for a Class I/II Respiratory/Anesthesia Equipment manufacturer in Lake Forest, IL that was spinning off and rebranding from Beckton Dickinson. Performed all aspects of Regulatory Affairs including 510k submissions, development of regulatory pathways for new products, remediation of Tech File records for CE marking, and writing and editing Clinical Evaluation Reports to comply with the new MedDev regulation in Europe.

02/2017-9-2017

Abbott Diagnostics (various diagnostic facilities in Canada, US, Scottland) - Contracted for Bioteknica consulting.

Evaluated complaints to determine reportability pertaining to the MDR and IVDR regulations.

To ensure compliance with the 510k regulation, I evaluated design changes to handheld diagnostic instruments (point of care) intended to analyze blood sample providing various drug testing results.

Participated in quality system audits of various facilities.

09/201*-**-****

Siemens Germany - Contracted for Bioteknica consulting.

Evaluated quality release records for MRI and Mammogram imaging devices confirming release criteria.

06-2023- 10/2023

Full Time Positions held in RA/QA.

Rauland Borg, Corp. (AMETEK) - Mount Prospect, IL 2/2012 – 10/2016

Director, Regulatory Affairs

Directed global Regulatory and Quality operations for Class II Medical Devices at the Mount Prospect Illinois manufacturing facility.

Lead and implemented CE Marking of Nurse Call System enabling first time access of product to the European markets. Developed Tech Files to support CE marking.

Significantly improved timing of global product registrations resulting in increase in sales of product in regions requiring registration of our products.

Restructured and transformed the quality organization resulting in improved product/process quality and quality operations efficiency.

Effectively managed the resolution of customer complaints.

Created and launched a new global Customer Complaint, and Field Corrective Action reporting process.

Ensured compliance with applicable global regulations and standards

Successfully implemented a Quality System Training program.

Successfully implemented UDI compliance regulation.

Regularly delivered formal presentations to senior leadership.

Baxter - Deerfield, IL 2006 – 2011

Manager, Global Regulatory Affairs

Responsible for global and domestic submissions and regulatory compliance in the areas of Class I, Class II Peritoneal and Hemodialysis electromechanical, stand-alone software, consumable accessories and dialysis solution drug products.

Developed and executed regulatory plans for complex new product development projects including new renal device products, dialysis solutions, and maintenance of licenses/authorizations for existing products.

Successfully wrote several highly complex 510k pre-marketing applications for software electromechanical devices supported by clinical study data.

Lead and represented the regulatory function on assigned cross-functional project teams including new product development projects for dialysis projects.

Developed and documented sound regulatory decisions and justifications to ensure timely US and worldwide submissions including ensuring the global translation process is adequately implemented.

Reviewed promotional material, design and material changes in order to evaluate impact on global submissions.

Omron Healthcare - Lake Forest, IL 2005 – 2006

Manager, Regulatory Affairs

Responsible for Global and Domestic product registrations for Class II medical devices including EKG’s, Nebulizers and Blood Pressure Monitors.

Managed all FDA, Canadian, South and Central American regulatory submissions for Class II Medical Devices.

Wrote several FDA 510k submission resulting in timely 90-day approval.

Established an excellent working relationship with the Engineering team in Kyoto, Japan to ensure that all product changes are evaluated properly to determine impact on global submissions.

Held several meetings at the FDA to obtain and determine possible regulatory pathways for new products

Abbott Laboratories (Diagnostics Division) - Abbott Park, IL 2000 – 2005

Regulatory Affairs Specialist/Project Manager, Operation Quality Assurance for Class II/III Med Devices

Provided technical support for Quality System compliance improvement program.

Performed PMA and 510k subject matter expert activities during various agency audits.

Strengthened procedural compliance by authoring and processing technical revisions.

Lead teams comprised of scientists and technical experts to utilize the Six Sigma MAIC (measure, analyze, improve, control) tools in developing an actionable root cause to problems arising during manufacturing and customer usage of various diagnostic products.

Lead teams during the Improve and Control phases of the Six Sigma MAIC process to ensure that viable solutions are developed to product problems and controls are in place to prevent recurrence of problems.

Administered regulatory and compliance activities related to audits/inspections from regulatory agencies including FDA, TGA (Australia), Canadian Authorities, Brazilian Authorities, UL, LRQA (Lloyds of London) and other third parties.

Played a key role in facilitation of the FDA inspection process including quality system training emphasizing FDA inspection readiness, record review, and coordination of subject matter expert interviews.

Performed effectiveness checks and verifications of quality system improvements, commitments and corrective/preventive actions resulting from FDA inspection activities.

Packard Bioscience (Perkin Elmer) - Downers Grove, IL 1994 – 2000

Regulatory Affairs Specialist

Effectively communicated, prepared and negotiated both internally and externally with various regulatory agencies (NRC, EPA, FDA, OSHA, DOT and IDNS) to ensure compliance to regulatory requirements.

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