Subbaram Reddy Nyarati
Maple Grove,MN
Summary
Regulatory Affairs professional with 7+ years of progressive experience supporting Class I, Class II, and Class III medical devices representing Cardiovascular Diagnostic devices and Laboratory developed tests (LDTs). Proven leader in developing and executing global regulatory and quality strategies to enable new product introductions, sustain marketed products, and ensure compliance with FDA QSR (21 CFR 820), ISO 13485, EU MDR, and ISO 14971. Extensive experience preparing and managing FDA submissions (510(k), PMA support), EU Technical Files, global registrations, labeling compliance, and post-market activities. Recognized for cross-functional leadership, audit readiness, regulatory risk management, and continuous improvement, with a strong ability to influence product development, manufacturing, and commercialization decisions. Strong working knowledge on Global Medical QA & Regulatory requirements and registration procedures including all IFU, UDI, GTIN, and preparing documents for legalization, apostille, and notarization. Complaint investigation & handling specialist - CAPA experienced (Filing and monitoring customer complaints).
Overview
11
11
years of professional experience
Work History
Senior Regulatory Affairs Specialist
NATERA Inc.
03.2024 - Current
- Developing and executing global regulatory strategies for complex IVDs and LDTs, supporting new product registrations and sustaining engineering changes across global markets.
- Leading the preparation and oversight of EU Technical Files, global regulatory documentation, and change assessments, interfacing directly with notified Bodies and international regulatory partners.
- Providing expert regulatory input on product labeling, IFUs, UDI/GTIN, and commercialization activities, ensuring alignment with EU IVDR, and international requirements.
- Serving as a RA team lead for product labeling as they relate to registration and commercialization of IVD’s.
- Monitoring the evolving global regulations and assess business impact, proactively advising senior leadership on regulatory risks, mitigation strategies, and compliance planning.
- Driving continuous improvement initiatives within Regulatory Affairs, including process enhancements, metrics reporting, and procedural updates.
- Demonstrating continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including policies applying to in vitro diagnostic devices including EU IVDR, MDR, global registrations, applied statistics, and technical writing.
Regulatory Affairs Specialist II
Bracco Medical Technologies (dBA: ACIST Medical Systems)
12.2019 - 02.2024
- Facilitated global registrations and license renewals in over 60+ countries, ensuring uninterrupted market access for Class II and Class III cardiovascular devices.
- Played a key role in EU MDD to EU MDR transition, performing comprehensive gap analyses and updating Technical Files, Design Dossiers, GSPRs, and Declarations of Conformity.
- Prepared, reviewed, and supported FDA submissions (510(k) and PMA activities), Annual Reports, and regulatory change assessments.
- Served as a regulatory partner to product development teams, providing guidance on design controls, risk management (ISO 14971), labeling, and post-market requirements.
- Developed, revised, and standardized SOPs and regulatory templates, strengthening QMS compliance and operational efficiency, including flowcharts and visual aids, to enhance process understanding.
- Supported audit readiness and regulatory inspections, including FDA, Notified Body, and internal audits, addressing observations through CAPA and remediation activities.
- Led field action and recall support activities, coordinating with cross-functional teams and regulatory agencies.
- Managed UDI regulatory controls, ensuring accurate country approvals, part number restrictions, and shipment compliance.
- Created and maintained UDI/GTIN records, including submissions to GUDID, supporting global traceability requirements.
- Prepared and submitted electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
Regulatory Affairs Specialist II
INTELLECTT, Inc.
01.2019 - 12.2019
- Supported global regulatory submissions and CE Marking activities for Class II and III cardiovascular diagnostic devices.
- Reviewed and maintained Technical Files, Design Dossiers, and FDA submissions, ensuring alignment with evolving regulatory standards.
- Provided regulatory oversight for design verification and validation, risk assessments, and labeling reviews.
- Participated in supplier audits and assessments against ISO 13485, ISO 14971, FDA QSR, and EU MDR requirements.
- Acted as a regulatory liaison between Manufacturing, Quality, and R&D, supporting new product introductions and process changes.
Regulatory Affairs Specialist I
CYBERMATE INFOTEK Ltd.
01.2015 - 07.2016
- Supported regulatory compliance for marketed medical devices, evaluating product, supplier, and manufacturing changes for regulatory impact.
- Coordinated regulatory submissions and approvals for manufacturing site transfers and international market expansions.
- Compiled and reviewed technical documentation related to biocompatibility, sterilization, shelf life, packaging, and V&V.
- Assisted in regulatory agency communications and resolution of compliance questions.
Education
Master of Science - Health Informatics
Marshall University
Huntington, WV08.2018
Bachelor of Science - Pharmacy
Vishnu Institute of Pharmaceutical Education & Research
India2016
Skills
FDA 21 CFR Part 820 (QSR/QMSR readiness) EU MDR/IVDR Strategy Support Change Impact Assessment cGMP cGDP ISO 13485 ICH Guidelines Risk Management (ISO 14971, CAPA, RCA, FMEA) PMS/PMCF Technical and Regulatory Writing eQMS governance (Trackwise, DotCompliance, MasterControl) Digital Systems & Analytics (RIMS, RegDesk, SAP, Oracle Agile, SharePoint, REDCap, Adobe InDesign, Tableau (Quality and Regulatory KPIs))
Timeline
Senior Regulatory Affairs Specialist
NATERA Inc.
03.2024 - Current
Regulatory Affairs Specialist II
Bracco Medical Technologies (dBA: ACIST Medical Systems)
12.2019 - 02.2024
Regulatory Affairs Specialist II
INTELLECTT, Inc.
01.2019 - 12.2019
Regulatory Affairs Specialist I
CYBERMATE INFOTEK Ltd.
01.2015 - 07.2016
Master of Science - Health Informatics
Marshall University
Bachelor of Science - Pharmacy
Vishnu Institute of Pharmaceutical Education & Research