Job Summary

As a key member of the team, you will play an integral part in helping Enovis drive the medical technology industry forward by transforming patient care and improving patient outcomes. Location: Hyderabad, India (Full Remote)

Department: Regulatory Affairs - Surgical International

Reporting Line: Surgical International PMS Vigilance Manager The Post Market Surveillance Vigilance Specialist is responsible for supporting global post-market surveillance and vigilance activities for medical devices marketed worldwide. The role contributes to ensuring patient safety, regulatory compliance, and continuous product improvement through complaint handling, regulatory reporting, trend monitoring, data analysis, and proactive surveillance activities.

The Specialist will work closely with Regulatory Affairs, Quality, Clinical Affairs, Risk Management, RD, Manufacturing, and local affiliate teams to ensure timely and compliant management of post-market information in accordance with applicable global regulations, company procedures, and quality system requirements.

Responsibilities

Complaint Handling Triage

- Perform intake, review, assessment, and data entry of product complaints within the electronic complaint handling system.
- Evaluate complaint completeness and request additional information when necessary.
- Perform initial triage and categorization of complaints according to established procedures.
- Support complaint review and follow-up activities to ensure timely processing and closure.
- Maintain accurate and complete complaint records in compliance with applicable quality and regulatory requirements.

Regulatory Reporting





- Prepare and maintain vigilance and adverse event reports for submission to Regulatory Authorities worldwide.
- Ensure regulatory submissions are complete, accurate, and performed within required timelines.
- Maintain documentation supporting regulatory reporting decisions and communications.

PMS Data Management Metrics

- Collect, consolidate, and analyze post-market surveillance data from multiple sources.
- Generate PMS metrics, dashboards, and periodic reports supporting management review and regulatory documentation.
- Support preparation of PMS Reports, Periodic Safety Update Reports (PSURs), and other post-market deliverables.
- Monitor data quality and identify opportunities for process improvement.
- Contribute to benefit-risk evaluation activities through data collection and analysis.
- Participate in proactive PMS initiatives aimed at identifying emerging risks and opportunities for product improvement.
- Perform complaint trending and statistical evaluations to identify potential safety signals.
- Support identification and escalation of adverse trends requiring further investigation.
- Collaborate with cross-functional teams to evaluate trend analysis outcomes and recommend appropriate actions.
- Support Health Hazard Evaluation activities through data gathering, analysis, and documentation.

Quality System Process Improvement





- Support revision and maintenance of PMS Vigilance Standard Operating Procedures (SOPs), Work Instructions, and associated forms.

Qualifications

Education

- Bachelor's degree in biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, Quality, Regulatory Affairs, or related scientific discipline.
- Advanced degrees are considered an advantage.

Education and Experience

- 1-3 years of experience in the medical device or healthcare industry.
- Previous experience in complaint handling, vigilance, regulatory affairs, quality systems, or post-market surveillance is preferred.
- Familiarity with:
- EU MDR
- FDA Medical Device Reporting requirements
- ISO 13485
- Post-Market Surveillance principles
- Complaint Handling processes
- Vigilance reporting requirements

- Experience using Agile PLM, complaint management databases, Power BI, Excel, or similar tools is advantageous.

Professional Competencies

- Robust analytical and problem-solving skills
- Attention to detail and data accuracy
- Effective written and verbal communication, English language
- Ability to work independently in a remote environment
- Strong organizational and prioritization skills
- Cross-functional collaboration
- Continuous improvement mindset
- Excellent knowledge of MS Office.
- Excellent interpersonal skills in multicultural contexts

Disclaimer: This job posting and location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Post Market Surveillance & Vigilance Specialist (Hyderabad)
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