chennai tamil nadu medical device quality Jobs – 105 Open Jobs Today

Quality and Regulatory Lead
Quest Global —Chennai, Tamil Nadu
- Full-time
- Master's degree
- Project management
- Bachelor's degree
Quick apply
Manufacturing Engineer - NPI
Quest Global —Chennai, Tamil Nadu
- Weekend availability
- Analysis skills
- Project management
- Continuous improvement
- Health insurance
- Paid time off
Quick apply
Automation Expert – Product Development (Healthcare & Medical Device)
CellBios Healthcare And Lifesciences —Chennai, Tamil Nadu
- Email
- Doctoral degree
- Engineering
- Java
Assistant Manager - Clinical - Chennai/Cochi
Fresenius Medical Care —Chennai, Tamil Nadu
- Full-time
- Nursing
- Bachelor's degree
Officer R&D
punitmediteck private limited —Chennai, Tamil Nadu
- ₹25,000 - ₹40,000 a month
- Full-time
- Microsoft Word
- Microsoft Office
- In-person
- Flexible schedule
- Food provided
Quick apply
Lead, Global Complaint Management
ICU Medical, Inc. —Chennai, Tamil Nadu
- Full-time
- Microsoft Powerpoint
- Nursing
- Microsoft Outlook
AR Analyst – Hospital Billing (Day shift)
SolvEdge —Chennai, Tamil Nadu
- Email
- Patient monitoring
- Analysis skills
- EMR systems
- Health insurance
Production supervisor-5-7y experience plastic injection, electronics, consumer durable, home applian
Lubdub Medical Technologies Pvt Ltd —Chennai, Tamil Nadu
- ₹25,000 - ₹35,000 a month
- Full-time
- Engineering
- Bachelor's degree
- In-person
Quick apply
Consultant – Medical Coder (E&M with MIPS)
SolvEdge —Chennai, Tamil Nadu
- Email
- Anatomy knowledge
- Microsoft Excel
- Patient monitoring
- Health insurance
Soldering Technician
Tekna Manufacturing —Chennai, Tamil Nadu
- ₹20,000 - ₹35,000 a month
- Full-time
- In-person
- Health insurance
Quick apply
Quality Control (QC) Manager
CellBios Healthcare And Lifesciences —Chennai, Tamil Nadu
- Email
- Master's degree
- Bachelor's degree
- Quality control
Mechanical Technical Lead – Medical Devices
Quest Global —Chennai, Tamil Nadu
- Full-time
- CAD
- Presentation skills
- Computer skills
Quick apply
Purchase Executive
Tekna Manufacturing —Guindy, Chennai, Tamil Nadu
- ₹20,000 - ₹45,000 a month
- Full-time
- Bachelor's degree
- In-person
- Negotiation
- Health insurance
Quick apply
14d
Freelance Medical & Regulatory Writer
Pepgra —Ambattur, Chennai, Tamil Nadu
- Doctoral degree
- English
- Master's degree
Production Supervisor
Lubdub Medical Technologies Pvt Ltd —Perungudi, Chennai, Tamil Nadu
- ₹30,000 - ₹35,000 a month
- Full-time
- English
- Project management
- Bachelor's degree
- Health insurance
Quick apply
Correspondence Specialist – Revenue Cycle
SolvEdge —Chennai, Tamil Nadu
- Email
- Patient monitoring
- EMR systems
- Care plans
- Health insurance
Staff Program Delivery Manager
Tekion —Chennai, Tamil Nadu
- Microsoft Powerpoint
- Product management
- SharePoint
- Health insurance
- Paid time off
RA Specialist (US-FDA)
CellBios Healthcare And Lifesciences —Chennai, Tamil Nadu
- Email
- Microsoft Office
- Master's degree
- Analysis skills
Senior Medical Coder
Precision Medicine Group —Chennai, Tamil Nadu
- Online application
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
17h
Quality Assurance (QA) Manager
CellBios Healthcare And Lifesciences —Chennai, Tamil Nadu
- Email
- Master's degree
- Bachelor's degree
- Leadership

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Quality and Regulatory Lead

Quest Global -
Chennai, Tamil Nadu

Quick apply

Job details

Full-time

Qualifications

Mechanical engineering
Mechanical Engineering
Quality management
Master's degree
Project management
Bachelor's degree
Quality systems
Manufacturing
Communication skills
FDA regulations

Full job description

Job Requirements

At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

Overview

Quest Global is seeking an experienced Quality and Regulatory Lead with 10 – 15 years of experience in the medical devices industry to lead and oversee regulatory activities. In-depth understanding of medical device quality management system. This role requires strong technical and regulatory knowledge. They ensure compliance with global regulations, manage product approvals and guide the clients in meeting regulatory requirements throughout the product lifecycle. Role requires strong understanding of medical device manufacturing process and quality systems.

Roles and Responsibilities

Lead and mentor a team of quality and regulatory professionals, fostering a culture of excellence and continuous improvement
Provide guidance on complex regulatory issues and training on new regulations
Develop and execute global regulatory strategies to support product approvals and market access
Conduct quality audits of R&D and Manufacturing plant.
Collaborate with cross-functional teams (R&D, Quality, Marketing etc.) to ensure alignment of regulatory requirements with business goals of the client
Manage interactions with regulatory authorities to facilitate timely approvals
Ensure compliance with relevant standards and regulations, including ISO 13485, EU MDR, FDA 21 CFR 820, QMSR, ISO 14971, IEC 62304, IEC 62366 and other applicable country wise and global requirements
Manage regulatory impact assessments for design and manufacturing changes
Oversee regulatory activities for product updates, labeling changes and post-market surveillance
Monitor and interpret evolving regulations to anticipate and manage changes
Ensure compliance of verification, validation and testing protocols with applicable standards

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.

Work Experience

Qualifications and Skills

Bachelor's or Master’s Degree in Biomedical Engineering, Mechanical Engineering, Electronics Engineering or related fields. Advanced degrees are preferred.
10-15 years of regulatory experience in the medical devices industry, with a proven track record of successful submissions and approvals
Strong knowledge of global regulatory frameworks, including US FDA, EU MDR, Health Canada, TGA etc.
Strategic thinking with a deep understanding of regulatory affairs
Excellent leadership, project management and communication skills
Ability to interpret and apply complex regulatory requirements effectively
Relevant certifications such as RAC or equivalent are highly desirable

Benefits

As per Quest company policy

Quick apply

Refine Your Search

medical device quality jobs in chennai tamil nadu

Quality and Regulatory Lead

Manufacturing Engineer - NPI

Automation Expert – Product Development (Healthcare & Medical Device)

Assistant Manager - Clinical - Chennai/Cochi

Officer R&D

Lead, Global Complaint Management

AR Analyst – Hospital Billing (Day shift)

Production supervisor-5-7y experience plastic injection, electronics, consumer durable, home applian

Consultant – Medical Coder (E&M with MIPS)

Soldering Technician

Quality Control (QC) Manager

Mechanical Technical Lead – Medical Devices

Purchase Executive

Freelance Medical & Regulatory Writer

Production Supervisor

Correspondence Specialist – Revenue Cycle

Staff Program Delivery Manager

RA Specialist (US-FDA)

Senior Medical Coder

Quality Assurance (QA) Manager

I want to receive the latest job alerts for medical device quality in chennai tamil nadu

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