Senior Post Market Surveillance Specialist

7 days ago


Hyderabad, Telangana, India Winnovate Enterprises Full time

Company DescriptionWinnovate Enterprises is an emerging and diverse company based in Hyderabad, specializing in a wide range of services tailored to the medical and pharmaceutical industries.

Our primary focus areas include regulatory services, seed funding for startups, and the development of cutting-edge products for the medical device sector.

Role DescriptionThis is a full-time on-site role for a Senior Post Market Surveillance Specialist located in Hyderabad.

The Senior Post Market Surveillance Specialist will be responsible for the following:

Performs maintenance as well as continuous improvements of the Post Market Surveillance (PMS) system.
Independently assures timely complaint initiation, investigation/analysis, reportability assessments, and reporting to appropriate regulatory authorities.
Evaluates documentation for completeness and consistency and execute additional actions as necessary to close the complaint file.

Complete adverse event reporting determinations per geography regulatory requirements for approved devices (US FDA, EU MDD/MDR, PMDA, etc.) in a timely manner.

Participate in PMS activities such as generating PMS plans, PMS reports (PMS-R), and/or period update safety reports (PSUR).Review, analyze, interpret, and summarize PMS data; draw conclusions and make appropriate recommendations and decisions.

Recognize complaint trends, potential product problems and potential recalls, and initiate immediate remedial action, if appropriate.
Prepare reports for management reviews, monthly complaint trend meetings, and other required reports, as requested.

Work closely with the Design Quality Engineering team to update Risk Management files when new failure modes or new frequency of occurrence are identified.

Review and recommend CAPA/SCAR actions where required to document improvements needed as a result of new failure modes or increases in complaint rates.

Interface directly with internal and external customers and regulatory agencies as required.

Qualifications


Bachelor's degree in engineering, life science, or a combination of education and experience providing equivalent knowledge.6+ years of complaint handling experience and post-market surveillance in the medical device or a regulated industry.

Working knowledge and experience with Medical Device Reporting, US FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR/MDD, vigilance reporting requirements, PMDA.Ability to work in a fast-paced environment with multiple tasks/projects.

Excellent prioritizing, organizational, and interpersonal skills.

A detail-oriented individual with a "can do" attitude and the ability to work in a team environment as well as individually (with minimal supervision).



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