Open to opportunities

Omkar Vivek Murtale

@omkarvivekmurtale

Message

Regulatory affairs professional ensuring global medical device compliance and streamlined submissions.

United States

Message

What I'm looking for

I seek a regulatory role where I can lead global device registrations and 510(k) strategies, collaborate cross-functionally, improve processes, and drive compliance and product market access.

I am a regulatory affairs professional with six years of experience ensuring FDA and global compliance for medical devices across markets including the EU, China, Taiwan, Singapore, Japan, South Korea and Australia.

I have prepared successful 510(k) submissions, developed regulatory policies and SOPs, implemented UDI-compliant labeling systems, and supported pre-submission meetings and product lifecycle technical files to improve traceability and compliance.

I collaborate with cross-functional teams in engineering, clinical, marketing and quality to support product development, change notifications, international registrations, and quality system activities to deliver timely regulatory strategies and executive-level updates.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Affairs Associate

Current

NeuroSync, Inc

Jan 2025 - Present (8 months)

Maintained Class II SaMD regulatory compliance per FDA 524B, supported pre-submission planning, and implemented an in-house UDI labelling system improving traceability and compliance.

FDA 524B SaMD UDI Labelling GUDID SOP Development Risk Management

Regulatory Affairs Specialist

Qinecsa Solutions

Aug 2022 - Nov 2023 (1 year 3 months)

Coordinated international IVD registrations and MDSAP activities, performed GAP analyses against FDA/EU MDR, and updated technical documentation and labeling to meet EU MDR 2017/745.

IVD MDSAP Gap Analysis EU MDR SharePoint MasterControl Technical Documentation

Regulatory and Safety Associate

Qinecsa Solutions

Mar 2021 - Jul 2022 (1 year 4 months)

Supported product registrations for Class II medical devices across Canada, APAC and LATAM, managed dossiers and labeling in Veeva Vault, and coordinated change notifications with in-country representatives.

Product Registrations Veeva CAPA Quality Assurance Change Notifications

Patient Safety Associate

Cognizant Technology Solutions

Jul 2018 - Mar 2021 (2 years 8 months)

Managed ICSRs per 21 CFR and E2B guidelines, processed clinical trial safety cases including SUSAR unblinding, and supported audit activities for safety processes.

ICSR Case Processing SUSAR Unblinding Audit Support Pharmacovigilance

Education

Degrees, certifications, and relevant coursework

Northeastern University

Master of Science, Regulatory Affairs for Medical Devices

Master of Science in Regulatory Affairs for Medical Devices expected completion in December 2025, focused on regulatory compliance and medical device submissions.