Senior Post Market Surveillance Specialist
2 weeks ago
Company Description
Winnovate 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 Description
This 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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