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Post Market Surveillance & Vigilance Specialist

Enovis · Hyderabad, India

FULL TIME

Job Description

Who We Are

ABOUT ENOVIS™

What You'll Do

At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it.

Because that’s how we change the lives of patients for the better. And that’s how we create better together. Why work at Enovis? .

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.

Post Market Surveillance & Vigilance Specialist – Enovis Surgical International

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, R&D, 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.

Major Accountabilities

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 MDRFDA Medical Device Reporting requirementsISO 13485Post-Market Surveillance principlesComplaint Handling processesVigilance reporting requirements
  • Experience using Agile PLM, complaint management databases, Power BI, Excel, or similar tools is advantageous.

    • Professional Competencies

  • Strong 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

    • “Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

    What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors:

    We offer a comprehensive benefits package which includes:

  • Medical, Life, and Accidental Insurance
  • Leaves and Holidays

    • EQUAL EMPLOYMENT OPPORTUNITY
    Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

    EQUAL EMPLOYMENT OPPORTUNITY
    Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

    Details

    CompanyEnovis
    LocationHyderabad, India
    TypeFULL TIME
    Nichemarketing

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