Post Market Surveillance & Vigilance Specialist

Who We Are

ABOUT ENOVIS™

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

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? See for yourself.

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

• 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.

• 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.

• 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.

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

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

• 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.

• 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

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