MasterControl QMS
Vignesh VR
Regulatory Affairs Associate - Embedded Product Design (EPD)
Summary
Resourceful Regulatory Affairs Associate with 3.5 years of extensive experience in ensuring that company products meet regulatory regulations. Adept in collecting, collating and evaluating data to provide findings. Accomplished at successfully obtaining licenses for 23 new products while ensuring all metrics were adhered to. Coordinated and hardworking with excellent regulatory and quality compliance expertise.
Overview
4
4
years of professional experience
5
5
Certifications
3
3
Languages
Work History
Regulatory Affairs Associate
Tata Elxsi
Pune
11.2021 - Current
- Gathered, evaluated, organized, managed and compiled information for various country submissions such as India, Thailand, Japan, Malaysia and Philippines.
- Assisted with regulatory product compliance initiatives such as preparation of submission deliverables.
- Analyzed product complaints and made recommendations regarding reportability.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Prepared and maintained document inventory for core dossier preparation.
- Consolidated global information relevant to Neuromodulation Products and monitored global submissions and approvals status.
- Used RDR and Calyx RIM (Regulatory Submission Tool) to create product technical file packages for global product compliance certifications of Neuromodulation and Pelvic Health products.
- Recommended improvements to processes.
Customer Support Engineer
Bangalore Medical Systems Pvt. Ltd.,
Bangalore
04.2020 - 12.2023
- Promoted purchase of service contracts and warranties by detailing benefits of each to customers.
- Used remote diagnostic tools to identify sources of certain customer issues.
- Delivered exceptionally high level of professionalism and support to each customer, upholding company's commitment to service.
- Trained customers to use and maintain equipment to reduce service issues.
- Partnered with customers, end-users and resellers to implement strategies and solutions.
- Answered calls and emails at help desk to assist customers with basic support, bug fixes and configuration issues.
Biomedical Engineer - RA/QA
Elexes Medical Consulting LLC.,
Bangalore
01.2021 - 11.2023
- Draft, Review, Update & Release the Quality Documents as per the applicable processes takes place at Elexes premises.
- Review, analyze and approve all the quality documents for publication at Elexes and assist all the employees of Elexes to start implementing the processes as per the defined quality procedures.
- Set up the Client QMS and assisted Client for the Supplier Audit Readiness by performing record generation for the respective quality processes at Client premises. Joined as one of the auditees on behalf of Client in facing the Supplier Audit and successfully completed the audit.
- Assist and prepare documents on behalf of client for applying CDSCO manufacturer license registration and successfully completed the registration processes smoothly in a stepwise manner.
- Undertaken the role as a Project Owner and Admin of the Project Delivery Management tool and assisted team on creation of various materials out the project learning's (i.e., Technical document preparation, various regulatory submissions such as FDA, EU MDR, TGA, ANVISA, MEDSAFE, Health Canada etc.)
- Supported by assisting the Client in registering their Establishment and listed their device in FDA Database.
Education
Bachelor of Engineering - Biomedical Engineering
Dr.N.G.P Institute of Technology
Coimbatore 07.2016 - 2020.09
HSC - Bio-Math
Blue Bird Mat. Hr. Sec. School
Tiruppur 07.2014 - 2016.04
Skills
Submission preparation
Accomplishments
- Achieved Project Excellence through effectively helping with compliance services.
- Collaborated with team of 3 members in achieving quality compliance (ISO13485) at Elexes.
- Supervised team of 6 members.
- Defined a Regulatory Strategy and Framework to Client for global market clearance.
Software
ZenQMS
Regulatory Documentum Repository
Calyx RIM (Regulatory Submission Tool)
JIRA and Confluence
Certification
Fundamentals of Digital Marketing by Google
Interests
Global Regulations
Mastering Software Tools
Framework Creation for Approach
Solutions for Compliance Challenges
Timeline
Being an Effective Team Member - LinkedIn
06-2022
Regulatory Affairs Associate
Tata Elxsi
11.2021 - Current
EU MDR 2017/745 - Mini Course
08-2021
Biomedical Engineer - RA/QA
Elexes Medical Consulting LLC.,
01.2021 - 11.2023
FORCE Biomedical - Certified Member
11-2020
Fundamentals of Digital Marketing by Google
05-2020
EF Standard English Test
05-2020
Customer Support Engineer
Bangalore Medical Systems Pvt. Ltd.,
04.2020 - 12.2023
Bachelor of Engineering - Biomedical Engineering
Dr.N.G.P Institute of Technology
07.2016 - 2020.09
HSC - Bio-Math
Blue Bird Mat. Hr. Sec. School
07.2014 - 2016.04
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