Abijith C
Regulatory Affairs | EUMDR | Medical Device Regulatory | Risk Management | Complaint Handling | DHF Remediation
- Role
- Senior Engineer at Tata Elxsi
- Location
- Pune, IN
- LinkedIn followers
- 500 followers
About Abijith C
Detail oriented Regulatory affairs engineer with 4 years+ experience in Technical…
Experience
Senior Engineer
Aug 2023 — Present · Pune, IN
Gap assessment and Remediation of technical documentation as per EU MDR 2017/745 requirements for medical devices.Referring Templates and SOPs as per EU MDR requirement for implementation of technical documents covering different aspects of medical device life cycle.Authoring and review of technical documents as per templates and guidelines created following EU MDR 2017/745 requirements.Expertise on authoring and review of Risk related documents as per standard EN ISO 14971:2019.Collaboration with cross functional teams to gather scientific and technical information and documentation requirements.Product understanding through literature survey, product description, drawings, intended use.Engaged in close communication with client to understand documentation requirements and updates in input reference documents or template changes.Skills: Risk Management (ISO 14971), EU MDR 2017/745, Technical Document Authoring, Gap Analsis, DFMEA, Microsoft Office, Interpersonal skills, DHF Remediation, GSPR.
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