Regaulatory Affairs, Quality Assurance, Compliance

Robert J. Zega

** ******** ******, ********, ** *7981 ******@*****.*** C 973-***-****, H 973-***-****

Regulatory Professional (Medical Devices, OTC drugs)

Regulatory / Compliance professional experienced in Medical devices, Combination products and OTC drugs. 510k, Pre-Manufacturing Notices and drug submissions.

Expert level knowledge of Quality Management systems including 21CFR 820, ISO 13,485-2016, Medical Device Single Audit program, MDD 93/42/EEC, MDR (Europe) and CMDCAS (Canada). Medical device labeling (US, Canada, EU).

Working knowledge of US, Canadian and EU Medical Device requirements. Multi-tasker sensitive to highly regulated and deadline-sensitive environments. Excellent communicator and cross functional team player (Manufacturing, Marketing, QA, R&D).

Key Skills:

oMedical device regulations

oISO -13,485-2016

o510k assessments

o Significant change review

oNotified Body experience

oFDA deficiency responses

oDirect Agency Negotiations

oMedical device labelling

oQuality system management

Education: B.S. Chemistry, College of Science and Engineering, Fairleigh Dickinson University

Technology: MS Office (WORD, Excel, PowerPoint, Access), Adobe, Sharepoint, Trackwise, FURLS

Languages: English, Spanish

WaterJel Technologies, LLC 06/01/16 – 04/01/18

Manager, Regulatory Affairs / Quality Assurance

Lead RA/QA functions for a manufacturer of Medical devices and OTC drugs.

Responsible for Regulatory Affairs, Quality Assurance functions.

Conducted risk and change evaluations to determine need for 510k.

Technical writer, responsible for data information required for 510k Notifications.

Domestic/global product registration, four in one year (Australia, Canada, Korea, Vietnam).

Knowledgeable of US, Canadian and EU medical device requirements.

Managed ISO 13,485 Certified Quality System with knowledge of MD-SAP program.

Experienced with Health Hazard Evaluations (HHE) and Health Risk Assessment (HRA) process.

Liaison with Regulatory authorities (CDRH, Health Canada, EU MDR) and Notified bodies.

Design of drug and device labels to meet agency requirements (US, EU, Canada).

Ingredient Identity, LLC 09/2015 – 03/16

Principal Regulatory Advisor

Sr. Advisor with a firm consulting in RA/QA for the Homeopathic drug, Supplement, Food industries.

Primary consultant in area of US and Canadian regulations.

Wrote Phase I GRAS/GRASE Assessments, collected data for final Notifications (Phase II).

Assessed need for and assembled data required for New Dietary Ingredient Notifications.

Provide general guidance in FDA regulations, labeling, label design, product claims.

Provided advice in the handling of market withdrawals, product recalls, FDA Form 483.

Advised clients in complex Regulatory and Quality issues.

Conducted GMP audits of manufacturing plants and laboratories.

Technical documentation development and management.

DSM Nutritional Products Inc.

Sr. Manager, Regulatory Affairs 03/2011 – 08/2015

Manager, Regulatory Affairs 10/2005 – 03/2011

Regulatory contact for a global manufacturer of active ingredients, excipients, additives, vitamins for food, supplement and pharmaceutical applications.

Member of team to write 510k Pre-Market Notification for veterinary medical device.

Reviewed clinical trial and toxicology data to assess risk category.

Direct negotiation with CDRH and Center for Veterinary medicine (CVM).

Served on cross-functional teams (Marketing, Product Development, Tech. Service, Toxicology).

Researched potential pre-launch regulatory issues and ensured compliance for life of product.

Assisted in development of regulatory strategy, shortening path to commercialization.

Authored complex Regulatory submissions for approximately 40 products with a 99% success rate.

Kept informed of regulatory climate and interpreted regulations for assigned portfolio.

Robert J. Zega page 2

Christian-Hansen Inc. 07/2003 – 09/2005

Manager, QA /RA – Human Health and Nutrition

Pharmaceutical excipients, flavors, natural colors, dairy cultures, probiotics.

Responsible for Regulatory and Quality Assurance for Pharmaceutical excipients group.

Conducted assessments of process change to determine potential impacts.

Assemble drug master files DMF) and tracked changes for annual reporting to FDA.

Member of Process Validations team, reviewed and approved final Validations report.

In-depth SOP experience (OOS, Process Validation, CAPA, Change Management, Document Control),

Assessed Quality System of manufacturing sites to comply with USP1078, 21CFR111 and 211.

Developed training programs for Good Manufacturing Practices (cGMP’s).

Member of team transferring site of manufacture from New Jersey to Wisconsin.

Phibro Animal Health 03/2001 – 05/2003

Manager, Quality Assurance

Managed QA for a manufacturer of API (veterinary antibiotics) and Type A Medicated Articles.

Member of team transferring business newly acquired from Pfizer.

Responsible to create network of contract manufacturers and contract laboratories.

Member of process validation team bringing processes on-line to meet set deadlines.

Investigated product complaints, determined corrective actions, wrote corrective action (CAPA) reports.

Reviewed manufacturing deviations, OOS investigations, and recommended path forward.

Managed Requests for change and determined any impact to products or processes.

Wrote and implemented SOP’s compliant to 21CFR Parts 211and 226.

Reviewed, approved and released batch records.

Sensient Technologies, LLC

Manager, Quality Assurance and Regulatory Affairs 1998 - 2001

Responsible for Quality Assurance and Regulatory Affairs for a manufacturer of FD&C colorants.

Overall responsibility for product quality and management of Analytical Chemistry (QC) laboratory.

Oversaw Material Review Board, made decisions regarding rework or other disposition.

Responsible for regulatory compliance with local, state and federal agencies.

Insured labels conformed to regulatory requirements of FDA, Cal-Prop 65, RCRA, NJRTK.

Wrote raw material and finished products specifications, insured SOP’s were GMP compliant.

Assessed deviations and determined appropriate Corrective and Preventive Action (CAPA).

Responsible for maintaining good relations with QA Managers of key clients.

Provided Good Manufacturing Practices education to plant personnel.

Professional Affiliations

Regulatory Affairs Professionals Society

American Society for Quality

Volunteer:

Head, Public Relations: NJ Ski Council

President: High Life Ski Club, Inc

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