Summary
Overview
Work History
Education
Skills
Personal Information
Certification
Affiliations
Timeline
Generic

MARC PERSAD

Lawrenceville,GA

Summary

Results-driven Regulatory Affairs professional with expertise in medical device compliance and quality assurance. Successfully navigated international registrations while developing regulatory strategies that align with FDA and EU MDR standards, ensuring product safety and market entry.

Overview

1
1
Certification
9
9
years of professional experience

Work History

Senior Regulatory Affairs Specialist

Becton Dickinson (BD) formerly Bard
05.2023 - Current
  • Home Care (Intermittent Silicone Catheters – Magic 3 hydrophilic intermittent, Magic 3 Go, Ready-to-Use, BD Uncoated, Touchless Plus Kits, Hydrosil, Hydrosil Rose)
  • EU MDR Remediation projects : Regulatory strategy document (RSD), Notification of change, Roadmap Report, FMR, update EU MDD license to MDR, archive MDD license, e-IFU verification
  • New STED creation for Magic 3 Go
  • RSD for temporary deviation waiver
  • NPD (new product development)
  • PureWick Flex 2.0: creation of Global regulatory strategy, review human factors design validation, risk management: AFMEA and residual risk review, assistance with patient questionnaire creation and review, Requirements Trace Matrix review, Voice-of-customer usability protocol and questionnaire for formative study
  • Sustaining engineering projects:
  • Assess regulatory impact of the change via:.
  • Notification of change assessment for impact on global/international regulations
  • US and EU assessment of change (if 510k or BIS Change notification is required)
  • UDI impact
  • Regulatory strategy document creation
  • Full market release report
  • International registration
  • Chaired meetings with team members to understand status of international registrations, additional assistance/questions that were sought by regional RA, assisted with gathering and submitting documentation to international regions
  • Compile documentation to be submitted to the regional RA design dossier for MOH submission
  • Assisted regional RA representatives in addressing pending queries from the country’s Ministry of Health, facilitating timely regulatory responses.
  • Creation of product licenses in our database (Regulatory information management system)
  • Successful completion of registration for the following countries.
  • Saudi Arabia
  • Egypt
  • Conducted periodic reviews of post-market surveillance for 19 intermittent catheter families, identifying compliance issues and ensuring product safety.
  • 19 Intermittent catheter family
  • Roadmap reports
  • Reviewed labeling index for accuracy and compliance with regulations, ensuring alignment with regulatory standards.
  • FDA Guidance Document and Consensus standards review
  • Techstreet/Engineering workbench standard search review.
  • Internal review of technical files and/or design dossiers and/or MDR STEDs
  • Create enforcement report – raw data from FDA Enforcement Report database
  • FDA 510k submission.
  • Touchless Plus Red Rubber straight tip intermittent catheter Kit (K254076, May 2026)
  • Touchless Plus Orange Rubber Coude tip intermittent catheter Kits (in-progress)
  • Support for third party OEM suppliers/distribution partners
  • Conod
  • Brightpath project (Distribution agreement project - EU MDR Remediation, labeling rebranding and review)
  • Energizer Project (BSI CN, supplier changes for component in foley trays, and sterilization cycle changes)
  • Bev er
  • RTU (ready to use) intermittent catheter international registration
  • BD uncoated intermittent catheter international registration
  • Labeling updates
  • Endourology (Nicore guidewire, Hydroglide guidewire, Proxis Ureteral Access Sheaths, Inlay Ureteral stents and Inlay Optima Ureteral Stents, inflation dilation catheters):
  • EU MDR Remediation and Sustaining engineering projects : RSD, NoC, Roadmap Report, FMR, update EU MDD license to MDR, archive MDD license, e-IFU verification
  • BSI MDD Extension and legal manufacturer declaration letter
  • Successfully complete the BSI EU MDR Extension Request Form to notify BSI of which products will require EU MDR Extension. (MDF7006)
  • Prepare letters to be submitted for Legal Mfg. for EU MDR Extension (Manufacturer Declaration of conformity letter per each product family)
  • Surveillance audits (Nicrore Guidewire)
  • MDSAP audits
  • FDA Pre-Amendment
  • Review list of devices and perform gap analysis to determine which products do not meet pre-amendment status criteria whether new 510k will be required and present findings to Leadership team and corporate
  • Labeling review
  • Review product Labels for all UICC Products to determine if correct CH Rep & UKCA rep information is present/updated, also note if Australian Sponsor is present on Label and EU Importer
  • PMS Review
  • Periodic review of product documentation..
  • X-force (N30 – inflation dilation catheters)
  • Roadmap reports
  • Labeling index review
  • FDA Guidance Document and Consensus standards review
  • Techstreet/Engineering workbench standard search review
  • Internal review of technical files and/or design dossiers and or MDR STEDs
  • Create enforcement report – raw data from FDA Enforcement Report database

Regulatory Affairs Specialist II

Natus Medical Inc. Neurology
02.2022 - 04.2023
  • Assess regulatory impact for new products and/or modifications to existing products; develop and execute regulatory plans to support medical device design control process and satisfy international standards for electromechanical medical devices
  • Managed international device and facility registrations to facilitate market entry and compliance across regions.
  • Maintain medical device product registrations and clearances
  • Reviewed and approved design documentation including change notices, test protocols, reports, and device labeling to meet regulatory standards.
  • Serve as cross functional regulatory team member for design and development projects
  • Constructed and maintained technical files to ensure compliance with MDD and MDR requirements.
  • Prepare other documentation including regulatory plan, rationale for not reporting to notified body, letter to file, Declaration of Conformity, etc.
  • Gap analysis on current documentation to align with current regulations
  • Reviewed product labeling for compliance with regulatory standards and internal procedures.

Quality Engineer – Quality Assurance and Regulatory Affairs

Natus Medical
Oakville, ON
10.2019 - 02.2022
  • Verified compliance with ISO 13485, MDSAP, EU MDR, FDA, and other country-specific regulations.
  • Supported internal and supplier quality audits through planning, checklist preparation, and report writing.
  • Assisted with certification audits and regulatory inspections.
  • Performed supplier gap analysis to identify deficiencies in supplier certification.
  • Prepared FDA responses for post-market surveillance reports.
  • Reviewed QMS documents across company systems to identify errors and inconsistencies.
  • Prepared quality audit materials and QMS documentation.
  • Supported management review meetings and quarterly data trend analysis through plan and report preparation.
  • Contributed to design and development activities through collaboration with cross-functional teams.
  • Served as quality representative during design review meetings.
  • Reviewed and approved documentation to confirm compliance with standards, regulations, and design requirements.
  • Verified quality documentation covered all stages of design process.
  • Reviewed test method validation to confirm the adequacy of test methods for product testing.

Complaint specialist – Quality Assurance and Regulatory Affairs

09.2018 - 10.2019
  • Process complaints into company’s complaint management system
  • Evaluate customer complaints to determine if they are reportable regulatory agencies (FDA, HC, EUI, MHILW, ANVISA, TGA, etc.)
  • Assess complaints according to Risk Assessment File to determine whether or not the issue is reportable
  • Submitted MDR to FDA, HC, and other regulatory agencies.
  • Developed rationales for not reporting, providing acceptable risk mitigation and justifications for complaints that could be potential Adverse Events but do not require reporting to regulatory agencies.
  • Conduct risk management assessments for product issues.
  • Identify appropriate risk mitigations for product issue to determine if further investigation and documentation are required (Rationale for not reporting- how risk is mitigated)
  • Organize documentation to facilitate timely regulatory compliance.
  • Coordinated investigations for device failures and malfunctions, ensuring thorough analysis and timely resolution.
  • Liaise with engineering to perform investigations on returned devices
  • Follow-up with manufacturing operations to ensure that devices are returned in a timely manner for investigation
  • Ensure appropriate documentation is completed, reviewed and attached to complaint file (Failure investigation report, product specification sheet, Risk Management File, etc.)
  • Identified common product issues to assess trends in out-of-box failures, damaged parts on arrival, and software issues.
  • Data analysis and monthly trending reports for:.
  • Complaint issues
  • Number of complaints processed per week
  • Trending product issues
  • Management review
  • CAPAs, NCRs
  • Other quality metrics
  • Service call audits

Quality Assurance & Regulatory Affairs Associate

Elastic Care/Pathway Group
08.2017 - 08.2018
  • Quality Management System: Assisted in establishing QMS according to 21 CFR 820 and ISO 13485.
  • Medical Device Software Compliance: Assist in documenting Software Requirements (SRS), Level of Concern (LOC)
  • FDA 510k: Prepare Class II Medical Device 510 (k) and FDA Pre-submission meeting.
  • Human Factors, Usability Testing: Provide a list of requirements, test plan and protocols according to ANSI/AMMI HE75 human factors standard, IEC 62366 and IEC 60601-1-6.
  • Design Control: Tracking Design and Development activities. Maintain DHF, DHR and DMR.
  • Risk Management: Maintain Risk Management documents according to ISO 14971 using FMEA and FTA tools.
  • Labeling: Provide a list of applicable requirements according to FDA Guidance, ANSI/AMMI HE75 standard, IEC 60601 Labeling requirements and predicate device labeling.
  • Change Management: Maintain Change Management documents such as Change control records and Change Control Tracker.
  • New Regulatory Requirement: Updated the team on latest standards and regulatory requirements, providing risk-based proposals to management for compliance.
  • Clinical Trial: Prepared ITA and IDE submission documents for clinical trials in Canada and the US, ensuring adherence to regulatory guidelines.
  • Conducted training sessions and presentations for team members.
  • Global Regulations: Conducted comprehensive research to develop regulatory plans for India, the US, Canada, and China.
  • Requirement management tool: Maintain requirements management tool (Matrix) to ensure tractability between requirement, specifications, testing, risk control and etc.
  • Coordinated project activities to ensure alignment with goals.
  • Update and export reports from Gantt charts
  • Use PM tools (MS Project) to provide different types of reports to executive managers and project sponsors
  • Review the progress of each project’s task and follow up with the designated lead/SME to meet deadlines
  • Assist with presenting the project's status for stakeholders
  • Collaborate with project team members to clarify dependencies between deliverables
  • Maintain QMS trackers to meet quality related milestones

Education

Masters of Science - Regulatory Affairs – Medical Device Stream

Northeastern University
Boston, MA
01-2023

Bachelor of Health Science Degree (Honours) -

University of Ontario Institute of Technology
Oshawa
01-2015

Skills

  • Medical Device Compliance: Regulatory Affairs and Quality Assurance Professional with experience in medical device QMS management, quality auditing, and regulatory licensing activities applicable to Health Canada, US FDA, EUI, and other jurisdictions Knowledgeable with MDSAP, ISO 13485, UKCA, Switzerland, SOB/98-282 and 21 CFR 820 regulations
  • Wellness Device compliance: Hands-on experience in regulatory affairs and compliance of wellness devices in US and Canada according to CPSC, FCC, ISED and OPC requirements
  • Other QA/RA Skills:
  • Excellent communication, proof-reading/document reviewing skills
  • Training facilitation experience
  • Project management experience
  • Proficient with MS Windows: Project, Word, Excel, PowerPoint, Corel Office, QMS, SharePoint, Lotus Notes, JIRA, and Agile

Personal Information

Title: Medical Device Regulatory Affairs and Quality Assurance

Certification

2022 Regulatory Affairs Professional Society, Online Certificate: EU MDR Compliance, 2020 BSI ISO 13485:2016 Lead Auditor Certification, Hands-on training and testing for applying ISO 13485:2016 standards, 2018-2019 Regulatory Affairs Professionals Society, Online certificate: Medical Devices-Risk Management: ISO 14971, 2017-2018 Humber College (Toronto), Postgraduate Certificate: Project Management

Affiliations

Regulatory Affairs Professionals Society (RAPS) member

Timeline

Senior Regulatory Affairs Specialist

Becton Dickinson (BD) formerly Bard
05.2023 - Current

Regulatory Affairs Specialist II

Natus Medical Inc. Neurology
02.2022 - 04.2023

Quality Engineer – Quality Assurance and Regulatory Affairs

Natus Medical
10.2019 - 02.2022

Complaint specialist – Quality Assurance and Regulatory Affairs

09.2018 - 10.2019

Quality Assurance & Regulatory Affairs Associate

Elastic Care/Pathway Group
08.2017 - 08.2018

Masters of Science - Regulatory Affairs – Medical Device Stream

Northeastern University

Bachelor of Health Science Degree (Honours) -

University of Ontario Institute of Technology
MARC PERSAD