Staff Regulatory Specialist
Staff Regulatory Specialist
Stryker
Job description
Looking to build a career in medical device post market intelligence? Explore this Staff Regulatory Specialist role at Stryker in Gurugram.
Company Description
Stryker is a medical technology company that creates products for MedSurg, Neurotechnology and Orthopaedics. The company focuses on patient care and improved healthcare outcomes all over the world. Stryker helps than 150 million patients every year with its products and services. It is famous for its award winning culture, strong employee benefits and a real focus on helping people live lives.
Job Summary
This hybrid job is in Post Market Intelligence, which's part of Strykers RAQA department, located in Gurugram. As a Staff Regulatory Specialist you will manage event assessments and regulatory reporting for medical devices in different parts of the world. Your job will include looking at complaints submitting Medical Device Reports and finding safety patterns. The job also requires working with Quality, Regulatory and Clinical teams.
Key Responsibilities
Do adverse event assessment and regulatory reporting for devices.
Check complaints to decide if they need to be reported and when.
Make, send and keep records of event reports and MDR submissions.
Look at complaint and adverse event data to find trends.
Work with Quality, Regulatory, Medical Safety and Clinical teams.
Help with reporting in different parts of the world including the US and Europe.
Keep records of assessments, submissions and messages.
Do follow up work to get missing information when needed.
Help with regulatory audits by providing the right documents.
Find ways to make reporting processes easier and more automatic.
Help with improvement and risk management projects.
Keep up to date with changes in medical device regulations.
Educational Qualification
Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, Regulatory Affairs, or a related field.
Skills Required
7 - 10 years of experience in areas including at least three years in adverse event reporting.
Experience with post market surveillance, regulatory affairs or handling complaints.
Good knowledge of medical device regulatory requirements.
Experience looking at complaints and deciding if they need to be reported.
Ability to handle cases and meet tight deadlines.
Good analytical. Careful attention to details.
Good. Speaking skills when working with teams around the world.
Good skills in Microsoft Office, Excel and PowerPoint.
Experience, with MDR, vigilance reporting or safety databases is a plus.
Knowledge of ISO 13485 ISO 14971 and EU MDR is helpful.
Salary Structure
The average annual salary for a Regulatory Specialist or related role at Stryker ranges from ₹13 Lakhs to ₹16 Lakhs, depending on your exact seniority level and experience.
Career Development
This role offers strong exposure to global medical device safety and regulatory work within a leading medical technology company. Stryker also supports long term growth through award winning benefits and opportunities to advance within its regulatory and quality functions.
How to Apply
Visit our job portal and search for the Staff Regulatory Specialist role in Stryker.
Click on the job posting to read all the details about the job.
Fill in your details. Upload your updated resume.
Send 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.