Open to opportunities

Mohamed Shaik Ashik R

@mohamedshaikashikr

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Dynamic Regulatory Specialist ensuring compliance with medical device standards.

India

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What I'm looking for

I am seeking a role that allows me to leverage my regulatory expertise in a collaborative environment, focusing on compliance and innovation in medical device development.

I am a dynamic and experienced Regulatory Specialist with a robust background in ensuring compliance with local and international regulatory standards. My expertise lies in leveraging extensive knowledge of EUMDR, ISO, and FDA requirements to develop effective regulatory strategies, ensuring the highest standards of safety and efficacy for medical devices.

Throughout my career, I have successfully developed and maintained Post-Market Surveillance Plans, Clinical Evaluation Plans, and Device Master File documents, facilitating smooth regulatory submissions and approvals. My role at HMS Medical Systems has allowed me to lead usability engineering documentation and risk management processes, ensuring compliance with IEC standards. I thrive in cross-functional collaboration, working closely with R&D, manufacturing, and regulatory teams to enhance product safety and efficacy.

With a strong foundation in biomedical engineering and a commitment to continuous improvement, I am dedicated to driving regulatory compliance and fostering innovation in medical device development. My achievements include creating a toxicological automation tool and leading efforts to identify alternative materials for sustainability, demonstrating my proactive approach to regulatory challenges.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Compliance Specialist

Current

HMS Medical Systems

Dec 2024 - Present (7 months)

Developed and maintained Post-Market Surveillance (PMS) Plans, Periodic Safety Update Reports (PSUR), Clinical Evaluation Plans (CEP), and Clinical Evaluation Reports (CER) in compliance with MEDDEV 2.7.1 Rev 4. Successfully prepared Device Master File (DMF) documents for CDSCO submissions and Design History File (DHF) documentation for USFDA approval.

Post Market Surveillance (PMS) Plans Clinical Evaluation Device Master File Design History File (DHF)ISO 13485 Regulatory Submissions Risk Management CAPA Quality Assurance

Regulatory Affairs Engineer

Tata Elxsi Limited

Feb 2024 - Nov 2024 (9 months)

Conducted comprehensive data collection from various material suppliers to ascertain their usage of PFAS and procurement sources. Spearheaded the identification of alternative suppliers for PFAS materials, ensuring compliance with EU legislation.

Data Collection Supplier Identification Sustainability Regulatory Affairs

Member Technical Staff

HCL Technologies Limited

Oct 2021 - Jan 2024 (2 years 3 months)

Developed regulatory strategies for medical devices to ensure alignment with PMDA, CDSCO, EUMDR, and FDA regulations. Led the regulatory submissions process, preparing and submitting documents to regulatory authorities.

Regulatory Strategy Regulatory Submissions Risk Management Technical Documentation Root Cause Analysis Import License Submissions Toxicological Risk Assessment Cross Functional Collaboration

Research Intern

Akas Medical Equipment Private Limited

Dec 2020 - Jun 2021 (6 months)

Assisted in research and development projects related to infusion pump technology and conducted literature reviews. Worked closely with management to understand ISO 13485:2016, ISO 14971:2019, and EUMDR 2017/745 requirements.

research and development literature review ISO 13485 ISO 14971 Regulatory Compliance

Education

Degrees, certifications, and relevant coursework

SKR ENGINEERING COLLEGE

B.E BIOMEDICAL ENGINEERING, BIOMEDICAL ENGINEERING

Grade: 7.57/10

Activities and societies: Final year project title: A compact device for intravenous fluid delivery

Completed a Bachelor of Engineering in Biomedical Engineering with a CGPA of 7.57/10. Coursework included Biomedical instrumentation, Diagnostic and therapeutic equipment, and Hospital management. Designed a compact and MRI-compatible infusion pump for the final year project.