Post Market Surveillance and Vigilance Specialist
Post Market Surveillance and Vigilance Specialist
Enovis
Job description
Looking to build a career in medical device post market surveillance? Explore this Post Market Surveillance and Vigilance Specialist role at Enovis in Hyderabad.
Company Description
Enovis is an innovation driven medical technology company. It focuses on developing solutions that improve outcomes and transform workflows. The company operates across orthopedics and beyond. It is powered by improvement, global talent and innovation. Enovis brings together a range of products, services and integrated technologies. The company support lifestyles worldwide. The company continues working to create outcomes for patients, teams and shareholders alike.
Job Summary
This remote role sits within Regulatory Affairs, Surgical International, based in Hyderabad. As a Post Market Surveillance and Vigilance Specialist you will support observation and monitoring activities for medical devices sold worldwide. Your work will involve handling complaints preparing reports and monitoring trends. You will also coordinate with teams, in Regulatory Affairs, Quality, Clinical Affairs Risk Management and Manufacturing.
Key Responsibilities
Perform intake, review, and data entry of product complaints in the complaint system.
Evaluate complaint completeness and request additional information when needed.
Initial triage and categorization of complaints according to established procedures.
Support complaint follow up activities to ensure closure in a timely manner.
Record complaints accurately to meet quality standards.
Prepare and maintain vigilance and adverse event reports for the regulatory authorities.
Make sure that regulatory submissions are both accurate and timely.
Support documentation for regulatory reporting decisions.
Collects and analyzes data from various sources of post market surveillance.
Prepare PMS metrics, dashboards and periodic reports for management review.
Assist in preparation of PMS Reports and Periodic Safety Update Reports.
Monitor data quality and opportunities for process improvement.
Analyze data to support benefit risk assessment activities
Engage in forward-looking surveillance activities to detect emerging risks.
Perform complaint trending and statistics checks to identify safety signals.
Support escalation of adverse trends that need further investigation.
Work with cross functional teams to evaluate trend outcomes and next steps.
Support Health Hazard Evaluation activities through data gathering and documentation.
Support the review and update of PMS and Vigilance SOPs and forms.
Educational Qualification
Bachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, Quality, Regulatory Affairs, or a related scientific field.
Advanced degrees are considered an advantage.
Skills Required
1 - 3 years of experience in the device or healthcare industry.
Prior experience in complaint handling, vigilance, regulatory affairs or quality systems is preferred.
Familiarity with EU MDR FDA Medical Device Reporting and ISO 13485.
Good understanding of post market surveillance and complaint handling processes.
Experience using tools like Agile PLM, Power BI or Excel is a plus.
Strong analytical and problem solving skills.
Strong attention to detail and data accuracy.
Good verbal English communication skills.
Ability to work independently in a setting.
Good cross collaboration and interpersonal skills.
Salary Structure
The average salary for a Post Market Surveillance and Vigilance Specialist at Enovis is typically estimated around ₹9 Lakhs to ₹10 Lakhs per year.
Career Development
This role offers exposure to global post market surveillance work within a growing medical technology company. Enovis also supports long term growth through a benefits package. It offers opportunities to build expertise in regulatory and quality functions.
How to Apply
Visit our job portal and search for the Post Market Surveillance and Vigilance Specialist role at Enovis.
Click on the job post to read all the details about the job.
Fill in your information. Upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.