Regulatory Specialist Medical Devices
Regulatory Specialist Medical Devices
Quest Global
Job description
Quest Global is hiring a Regulatory Specialist for Medical Devices in Bengaluru, offering a strong career path for professionals who want to work on global medical device compliance.
Company Description
Quest Global is an engineering services company that works in industries. These include MedTech and Healthcare, Aerospace, Automotive and Energy. The company has engineering and delivery centers in countries around the world. Quest Global wants to hire people who're curious and who see engineering everywhere. These people bring ideas to their work. the company creates a culture of respect, humility and growth, for all its employees and that culture of respect humility and growth feels real and supportive.
Job Summary
This job is for a Regulatory Specialist who works on devices. The job is based in Bengaluru. The person will help with submissions. They will also make sure that technical documents follow standards. This job involves working with authorities like the FDA and Notified Bodies. It also includes helping with audits. Good knowledge of MDR rules and FDA rules is needed for this job and a solid grasp of medical device standards will help you succeed.
Key Responsibilities
Verify submissions for medical devices in different markets like the United States, European Union and other areas.
Make files and documents up to date with the MDR and FDA rules.
Work with product teams, quality teams and engineering teams to solve questions.
Help with audits. Ensure documents are ready for inspection at all times.
Keep track of changes, in rules. Inform the teams about the impact of these changes.
Check device classifications. Spot any regulatory risks early.
Answer questions from authorities and Notified Bodies quickly.
Give guidance to project teams on strategy during new product development.
Help with training on topics for other team members when needed.
Educational Qualification
A degree in life sciences, biomedical engineering or a related field is needed for this role.
Around 3 to 5 years of experience in medical device regulatory affairs is preferred, along with knowledge of ISO 13485 and related standards.
Skills Required
Good understanding of FDA rules EU MDR and other global device regulations.
Understand quality management systems like ISO 13485.
Have writing and speaking skills.
Pay attention to detail when dealing with technical documents.
Work well with engineering and quality teams.
Have good organization skills to manage submissions and deadlines.
Salary Structure
The estimated salary for a Regulatory Specialist for Medical Devices at Quest Global is approximately ₹9 Lakhs to ₹10 Lakhs per year.
Career Development
This job gives experience in global medical device regulations and real-world compliance work. It can lead to roles in regulatory affairs or regulatory leadership over time.
How to Apply
Visit our job portal and search for the Regulatory Specialist Medical Devices role in Quest Global.
Click on the listing to see all the details, about the job.
Fill in your information and upload your 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
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