Regulatory Affairs Project Manager

CURRICULUM VITAE

NAME MICHAEL TOMASOVICH, MS RAC

ADDRESS ***** ******* ******

Livonia, MI 48154

CELL 734-***-**** FAX 313-***-****

EMAIL ************@*****.***

A regulatory affairs professional, project manager and business development leader dedicated to diligently assisting with the development and approval of therapeutics and medical devices at FDA and around the world.

SKILLS

INDs/BLAs/NDAs/ANDAs

510K/513G/PMA/IDEs/CE Mark/EUA

Rx/OTC/Supplements/ Cosmetics/Nutraceuticals

US FDA Regulatory Strategy

QSUB/Pre-IDE/Pre-IND/Pre-OMOR Requests & Meetings

cGMP Compliance

EU/MDR/IVDR Compliance/Remediation

Tech File Development/Remediation

Design/Engineering Change Assessments

Labeling/Promotional Material Review

UDI Compliance

Orphan/Fast Track Designations

Product/Site Registrations

Quality System Regulation (QSR) Development

EDUCATION

MS 2009 Northeastern University, Boston, MA: Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

BS 2005 Eastern Michigan University, Ypsilanti, MI: Bachelor of Science in Paralegal Studies – Dean’s List 2003-2005; Magna Cum Laude

AS 1991 Montcalm Community College, Sidney, MI: Associate Degree General Studies – High Honors (3.97 gpa)

PROFESSIONAL EXPERIENCE

11/2004 – Present Regulatory Affairs Associates, LLC. West Bloomfield, MI

Senior Regulatory Project Manager (ad hoc consultant)

Oversee and manage regulatory professionals during initiation and throughout project development (up to 8 reports)

Prepare and evaluate all project details including time, cost, and personnel allocation

Development, implementation, and monitoring adherence of operating procedures and policies

Project analysis and implementation including vendor selection and management, and overseeing planning and launch procedures

Prepared pre-IND, pre-IDE, pre-OMOR meeting requests and briefing packets for submission to FDA

Prepared INDs, INADs, NDAs, ANDAs for submission to FDA using electronic submission in eCTD format

oTopical oncology drug

oOncology drug for AML patients

oAnti-arthritic drug

oNasal steroid/decongestant

oTHC/CBD tablet for pain associated with osteoarthritis

oTHC/CBD tablet for pain associated with bone cancer in dogs

oSublingual CBD tablet for diabetic peripheral neuropathy

Prepared IDEs, 510(k)s, 513(g)s and PMAs/PMA Supplements for submission to FDA

o15+ 510(k) submissions

o5 PMA projects

o3 513(g) submissions

Prepared and submitted EUA applications

oSARS-CoV-2 Rapid Antibody Test

oInhaled Nitric Oxide (NO) sachet for use in N-95 mask for deactivation of SARS-CoV-2 virus

Combination Product (drug/device) consulting and GAP assessments

Prepared and submitted MUMS certification request and ADUFA fee waiver

Prepared amendments, respond to deficiency letters and coordinate activities to secure approvals in a timely fashion

Assist clients with QSR development, ISO 13485 compliance, ISO 14971, obtaining CE Marks, 21 CFR Part 11 compliance, SOP development, and cGMP, cGLP, and cGCP compliance

EU / MDR updates, evaluations and remediations

Conducted and managed quality audits

Conducted CAPA assessments and worked with sponsors to integrate appropriate corrective actions

Prepared responses and worked with clients in remediation of warning letters and non-conformance issues

Assist with product registration/submission (drugs, medical devices, cosmetics, nutraceuticals) in US, Canada, EU, Australia, Japan, and Brazil

Conducted product label and PI review for US, Canada, and EU product marketing

oUDI training and implementation for patient warming device, brachytherapy MRI marker, and TENS device

oDietary supplement labeling and ingredient review

oCombination (drug/device) labeling review for HF and clinical evaluations supporting IND as well as final product labeling (PI and UDI)

oReview/Edit/Prepare product labeling, Investigator’s Brochure and marketing materials for drug and device products

oClaims and product labeling assessment for circumcision wound dressing product

oProduct labeling and claims review for parenteral container

oProduct labeling and claims review of OTC products for nasal and ear lavage

Resolve regulatory issues involving the US Consumer Product Safety Commission

Regulatory evaluation of new drug and device technologies, creating regulatory Gantt charts specifying regulatory, toxicology and clinical project requirements

Project Manager of 52 National Cancer Institute (NCI) drug and device companies under federal contract to provide regulatory consulting services

Project Manager for 12 National Eye Institute (NEI) companies under federal contract to provide regulatory consulting services

Oversee and manage project associates throughout project development

Initiate contact with existing and prospective clients to determine needs and possible projects

Prepare and review all contracts, non-disclosures, requests for proposals, and all other initiating documents with existing and prospective clients

Maintain data integrity for nearly 4000 records as well as developing and implementing data maintenance policies and procedures

Contract negotiation and performance as well as research and summation of client needs

Editor and supervisor for company newsletter and advertising materials

Initial contact for all prospective employees and responsible for all other human resource duties

Recruit new personnel to meet the needs of client requirements while maintaining/updating CVs/files on 50+ consultants

11/2006- Present MET Servicing, LLC, Livonia, MI

President

Personal FDA regulatory consulting service

Provided generalized/ad hoc regulatory consulting services to drug and medical device companies

Drafted and implemented various SOPs for contracted clients

Assisted clients by conducting GMP and ISO related audits of existing facilities

Conducted employee training within various firms pertaining to GMP regulations and compliance

Conduct IND GAP assessment for drug/device combination product with focus on product labeling, use, overall container/closure and testing requirements

8/2020 – Present Professional Resource Partners, Mount Freedom, NJ

Senior Regulatory Affairs Specialist (ad hoc consultant)

Regulatory consultant to various companies providing specified and ad hoc consulting services

Prepared submission and requested Pre-Submission meeting with FDA for:

oEndovascular Catheter Suture Delivery system

oPre-operative planning aid used with shoulder arthroplasty

oTranscatheter Aortic Heart Valve

oConcussion diagnostic (IVD)

oSARS-CoV-2 Total Antibody Test

Prepare submission and request breakthrough designation for novel medical device

Regulatory assessment of drug specific biomarker system for better clinical design and more effective drug treatments

PMA supplements for Hyaluronic acid used for joint pain treatment from osteoarthritis

Trade Agreements Act (TAA) compliance assessment

PEUA application for Covid-19 saliva-based diagnostic

Technical file development

Early Feasibility Study (EFS) request (IDE)

Development of Vendor audit template

Orthopedic Surgical Navigation System

Develop and implement 21 CFR 820/ISO 13485 compliant QMS for medical device firm

Labeling review for 1200+ products

Regulatory assessment for neurological assessment device

IND combination product (drug/device)(CDX) GAP assessment

8/2023 – Present CSSi LifeSciences, Columbia, MD

Director, Regulatory Affairs

Regulatory consultant to various clinical and medical device projects

Review/approve regulatory assessments authored by direct reports

Identify strategic pathways for product development

Conduct planning and GAP assessments

Engage/lead health authority meetings

4/2024 – Present Actalent, Raleigh, NC

Regulatory Affairs Specialist

510k GAP assessment/development

IND eCTD assessment/development

EU MDR data extraction for CER development

EU MDR remediation/Directions for Use (DFU)

Regulatory Strategy

Ad hoc services

8/2021 – 7/2023 Clinical Partners Group, Santa Monica, CA

Consultant, Quality and Regulatory Affairs

Regulatory consultant to various clinical and medical device projects

510(k) remediation for Punctal Plug including FDA Pre-Submission Meeting and complete RTA response with revised 510(k) application

Biocompatibility justifications

Human Factors Testing justification

2/2022 – 12/2022 Becton Dickinson, Vernon Hills, IL

Regulatory Affairs Specialist / Advertising and

Promotional Material reviewer (Contract)

Ad/Prom review and approver

Develop product playbooks for internal training

Manage and review content for new website: www.herniainfo.com

Manage and review new and revised MLR content for internal and external use

Manage and review proposed product labeling for compliance with FDA clearance and approvals of medical products

2/2022 – 8/2022 Abbott Point of Care, Princeton, NJ

Regulatory Affairs Specialist (Contract)

Regulatory review and study summary preparation

510(k) preparation

Weekly regulatory review meetings

Cross-functional team interactions

4/2021 – 10/2021 Haemonetics, Natick, MA

Regulatory Affairs Manager (Contract)

Regulatory manager for all blood plasma products

Change assessment reviews

Regulatory review and assessment for implementation of new product operating software update

Regulatory review and assessment and new 510(k) planning for new component design

Weekly design and development meetings for various projects

Cross-functional team development and integration with global regulatory counterparts

6/2020 – 12/2020 DJO Global, Austin, TX

Senior Regulatory Affairs Specialist (Contract)

UDI Device Classification

Review of over 20,000 product listings

Verification of device classification, product code, governing regulation, and obsolescence

12/2019 – 1/2020 Smile Direct Club / Access Dental, Antioch, TN

Senior Regulatory Affairs Specialist (Contract)

Technical file auditing

EU MDR transition and compliance

QSR auditing and update

SOP creation

STED file development

Working with cross-functional teams for EU MDR compliance

7/2019 – 9/2019 Medtronic, Minneapolis, MN

Senior Regulatory Affairs Specialist (Contract)

Work with cross-functional teams on product change notifications (PCNs) and change development process (CDPs)

Engineering Change Order (ECO) review

Assisting with implementing EU/MDR changes/updates including CER reviews and STED file updates

Perform regulatory change assessments

9/2016 – 9/2018 Covidien/Medtronic, Boulder, CO

Senior Regulatory Affairs Specialist (Contract)

Respond to FDA requests for additional information for 510(k) submission

Create STED files of 510(k) submissions for use in other jurisdictions

Work with cross-functional teams on product change notifications (PCNs) and change development process (CDPs)

Engineering Change Order (ECO) review

Assisting with implementing EU/MDR changes/updates including CER reviews and STED file updates

Perform regulatory change assessments for engineering, processes and labeling changes

Confirm registrations of products and status for various jurisdictions around the world through contact with in-country rep

Regulatory issue resolution

11/2016 – 4/2018 VitaHeat Medical, LLC., Rolling Meadows, IL

Director Regulatory & Quality

Oversee and manage all regulatory and quality aspects for company and medical devices

Draft and implement 21 CFR 820 and ISO 13485 compliant quality system

Review and manage DMR and DHF

Conduct regulatory reviews and create memos to file for device changes

Train staff on quality system

Monitor and advise on complaint and CAPA handling

Conduct product change notification (PCN) review

Supplier quality audits

Label review and claims evaluation, UDI compliance and GUDID registration

Interact with CMO on product issues

Work with development team to identify testing for new device

10/2017 – 2/2018 Now Diagnostics, Springdale, AR

Senior Regulatory Specialist (Contract)

Provide UDI support for list of several diagnostic assays

Create GUDID listing for class II diagnostic assays

Create UDI numbering for FDA and EU regulatory compliance

11/2014 – 2/2015 American Medical Systems, Inc. Minnetonka, MN

Senior Regulatory Affairs Specialist (Contract)

Engage with cross-functional teams to address regulatory issues

Maintain, update and revise project and regulatory plan

CAPA and Change Order technical reviews

Regulatory project assessments

PMA Supplement for new indication

PDP Real Time Review

Mentor junior regulatory affairs specialist personnel

9/2009 – 9/2010 Eastern Michigan University, Ypsilanti, MI

Adjunct Professor – Regulatory Affairs

Providing instruction in regulatory affairs and new drug development for graduate level students

Mentor of students preparing thesis papers in CRA Masters program and preparing for RAC certification

7/2005 – 6/2007 LegalTech LLC Plymouth, MI

Paralegal

Outsourced paralegal for web-based service – www.legalsupportstaff.com

Prepare appellate briefs, motions, memoranda of law, record summaries, and provide various forms of legal research

3/2004 – 11/2004 McCall & Trainor Waterford, MI

Paralegal

Research and case development for 1st and 3rd party auto negligence

Maintained 50+ active files for 2 attorneys in 8 attorney firm

Ordered records, contacted clients, prepared complaints, motions, and subpoenas, did record summaries, scheduled depositions, and provided various forms of trial prep

10/2003 – 3/2004 Ann Arbor City Attorney Ann Arbor, MI

Legal Assistant/Intern

Assisted with grants of easement and land acquisition for city

Updated data bases and forwarded final documentation to city personnel

Registered deeds with county clerk and filed registered materials with city clerk

Research of land titles through county clerk’s office

Prepared collection letter for outstanding fines and violations, and filed appropriate documentation with district court

2/2003 – 10/2003 US Federal/Hunt Street Law Center Detroit, MI

Process Service Officer/Investigator

Served legal documents for Friend of the court, attorneys, and private citizens

Completed fully detailed written reports based on service attempts, neighborhood checks and postal verification

Investigated persons/business for attorneys, private citizens, and governmental agencies

SPECIAL PROJECTS/TRAINING

TITLE DATE

AdvaMed - Medical Device Reimbursement Specialist

Workshop (Las Vegas, NV) February 2007

Creating Real Value: Product Registration in Brazil June 2008

Critical Updates – The Italian Medical Devices Database January 2009

Medical Device Regulations in Latin America – Colombia August 2009

New FDA Goals Mean New Expectations for Industry:

Are You Ready for PDUFA V? July 2012

An Insider’s View of the Medical Device Clearance Process July 2012

The Version-Zero 510(k): Smoothing Your Complex 510(k)

Submission Path Through FDA August 2012

Entrepreneurial Boot Camp November 2012

Tools for Effective Supplier Controls in Support of

Medical Device Industry June 2013

The Affordable Care Act: What the Employer Mandate

Delay Means for Your Business July 2013

HIPAA Compliance at GxP Facilities August 2013

The Heart of Practical Marketing for Small Business:

You and Your Customer August 2013

Employment Law August 2013

Unique Device Identification (UDI) Requirements and

Timelines October 2013

The Latest Contract & Negotiation Tips January 2014

The Quality System Regulation January 2014

When Efficacy Isn’t Enough: Integrating Product

Commercialization Strategy Into Clinical and

Regulatory Planning January 2014

Pharmaceutical Manufacturing Regulations:

Navigating the Complexities January 2014

Keys to Success for Your Integrated Summary of

Safety (ISS) and Integrated Summary of Efficacy (ISE) February 2014

FDA Pre-Submission Meetings & Your Device: The

Elements of Reaching a Successful, Productive Outcome February 2014

FDA DQSA Serialization Requirements March 2014

The Global Orthopedic Market July 2014

Expert Guidance on Validating Cloud Systems July 2014

EMC and Electrical Insulation Requirements for

Medical Devices August 2014

Strategy & Preparation of an IDE Application September 2014

Custom Device Exemption October 2014

Risk Management Under 60601: From Safety &

Performance to Environmental Risks in Medical Devices October 2014

Content of Premarket Submissions for Management of

Cyber Security in Medical Devices November 2014

CDRH Industry Basics Workshop (6 hrs) November 2014

Distinguishing Recalls from Enhancements November 2014

FDA: UDI 101 and Getting Ready for GUDID January 2015

12 Steps for Accurate UDI Submissions to the GUDID January 2015

Miniaturization of Medical Devices: The Future of

Patient Care January 2015

FDA Webinar: Perspectives and Approach on Digital

Health, Mobile Medical Applications, and General

Welfare February 2015

Exploring Consent – An IRB’s Perspective on eConsent

Technologies and Human Subject Protection February 2015

FDA Webinar: Understanding the New FDA Guidance on

Data Standards March 2015

FDA Webinar: Reprocessing Medical Devices in Health Care

Settings: Validation Methods & Labeling FDA Guidance March 2015

Cleveland State University Seminar – International

Standards – Europe and China, CE and CCC Marking

(Westlake, OH) (4 CEUs) March 2015

QMed Webinar – ISO 14971 – Overview and Product

Development Process Integration (3 hrs) April 2015

UDI Class II Device Submissions: What you need to know November 2015

FDA Webinar: HFE for Medical Devices February 2016

FDA Webinar: Stability information in 510K February 2016

FDA Webinar: UDI March 2016

FDA Webinar: Symbols in Labeling July 2016

FDA Webinar: ISO 10993-1 July 2016

FDA Webinar: IDE July 2016

FDA Webinar: When to Submit a 510k for Change August 2016

ISO 14971 Risk Management: Industry Procedures and

Best Practices August 2016

Changing In Vitro Diagnostic Regulations: A Deep Dive

Into the new EU Requirements for Clinical Evidence August 2016

CDER Webinar: Electronic DMF August 2016

FDA Webinar: General Wellness – Low Risk Devices September 2016

FDA Webinar: Self-Monitoring Blood Glucose Test Systems

For OTC use and Rx Point-of-Care use November 2016

FDA Webinar: Post Marketing Management of Cybersecurity

In Medical Devices Final Guidance January 2017

483 Observations, Trends and Expectations July 2017

UK NHS eProcurement August 2017

Cybersecurity August 2017

FDA Webinar: “Evaluation and Reporting of Age, Race,

and Ethnicity Data in Medical Device Clinical Studies.” October 2017

FDA Webinar-Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices October 2017

FDA Webinar: “Deciding When to Submit a 510(k) for a

Change to an Existing Device” and “Deciding When to

Submit a 510(k) for a Software Change to an Existing

Device.” November 2017

FDA Webinar- FDA Categorization of Investigational Device

Exemption Devices to Assist the Centers for Medicare and

Medicaid Services (CMS) with Coverage Decisions January 2018

RAPS Webinar: Understanding and Applying FDA’s

510(k) Modifications Guidance April 2018

Webinar – Chemical Characterization and Toxicological

Risk Assessment for Medical Device Biocompatibility August 2018

Webinar – How to address Regulatory Changes in Your

Biocompatibility Program August 2018

Webinar – Overview of the MDSAP Certification Process August 2018

FDA Webinar – Benefit-Risk Factors to Consider When

Determining SE in 510k’s with Different Technological

Characteristics November 2018

FDA Webinar – Production and Process Controls and

Documents, Change Control and Records November 2018

FDA Expectations for Medical Device Human Factors

Activities May 2019

RAPS Webcast: How to Facilitate Regulatory Meetings May 2019

Accelerating Site and Patient Enrollment for Phase I

Trials July 2019

Breakthrough Designation Program: Is this an option

for my medical device? July 2019

The 505(b)(2) Pathway: Getting to the Clinic Faster July 2019

The Special 510(k) program October 2019

The Impact of FDA’s Guidance of Management of

Cybersecurity in Medical Devices October 2019

Submitting IND Safety Reports November 2019

FDA Webinar - OTC Monograph Reform: OMOR Format

& Content & Electronic Submissions August 2023

FDA Webinar – Use of ISO 10993-1 October 2023

FDA Webinar – Laboratory Developed Test (LDTs) October 2023

Extractables and Leachables: Setting Up Early for

Success with your CDMO March 2024

FDA Webinar - Laboratory Developed Tests (LDTs):

Final Rule May 2024

FDA/CDRH Webinar – Enforcement Policies for Tests

Draft Guidances June 2024

Best Practices for Engaging with the US FDA on HFE

Strategy and Submissions July 2024

PAPERS

Protecting The Children: A review and discussion on FDA attempt to increase pediatric drug testing. Masters program. 2008. Northeastern University.

CERTIFICATIONS

Regulatory Affairs Certified (RAC)

SOFTWARE SKILLS

MS Office Suite

MS Office Project

Word Perfect

Adobe Professional

West Law

Lexis Nexis

Time Matters

MedXview e-CTD software

Sales Force

Agile

Sharepoint

Insight

Avaza – Project/Time mgmt.

Zinc MAPs

Liquent Insights

Docubridge One eCTD Submission software

Veeva Vault

Showpad

PROFESSIONAL AFFILIATIONS

MichBio

Ohio Bio

Colorado Bio

Advanced Medical Technology Association (AdvaMed)

RAPS

REFERENCES

Available Upon Request

Contact this candidate