Bengaluru Karnataka Quality assurance medical devices Jobs – 75 Open Jobs Today

Regulatory Specialist – Medical Devices
Quest Global —Bengaluru, Karnataka
- Full-time
- B.Sc
- Microsoft Office
- Bachelor's degree
Quick apply
Regulatory Affairs Specialist
Dozee —Bengaluru, Karnataka
- Full-time
- Project management
- Bachelor's degree
- AI
1d
Regulatory Affairs Specialist
Natus Sensory —Bengaluru, Karnataka
- Full-time
- Remote
- English
- Continuous improvement
- Health insurance
- Paid time off
QARA Executive
Oivi —Bengaluru, Karnataka
- Hybrid work
- Engineering
- Microsoft Office
- Bachelor's degree
Quality Head
Jana Med Tech Pvt. Ltd. —Bengaluru, Karnataka
- ₹8,00,000 - ₹16,00,000 a year
- Full-time
- Master's degree
- Bachelor's degree
- Quality control
- Health insurance
Quick apply
Regulatory Affairs Expert
Fresenius Medical Care —Bengaluru, Karnataka
- Full-time
- Engineering
- English
- Master's degree
Associate Quality Engineer
Zimmer Biomet —Bengaluru, Karnataka
- Full-time
- Remote
- Computer Science
- Analysis skills
- Bachelor's degree
9d
Senior SDET
GE HEALTHCARE —Bengaluru, Karnataka
- Computer Science
- Bachelor's degree
- JavaScript
2d
Quality Engineer I
Zimmer Biomet —Bengaluru, Karnataka
- Full-time
- English
- Microsoft Office
- Project management
6d
Sr. Technical Writer
Analog Devices —Bengaluru, Karnataka
- Full-time
- Engineering
- English
- Bachelor's degree
Analyst Supplier Quality
Fresenius Medical Care —Bengaluru, Karnataka
- Microsoft Excel
- B.Sc
- Engineering
Program Manager
ZEISS Group —Bengaluru, Karnataka
- Full-time
- Computer Science
- Master's degree
- Project management
Manager/Senior Manager - External Supplier Quality – Digitalization & Analytics, GCC
GlaxoSmithKline —Bengaluru, Karnataka
- Full-time
- Azure
- Master's degree
- SQL
Lead Systems Engineer - Registration Documentation (Healthcare/medical devices)
Radiometer —Bengaluru, Karnataka
- Full-time
- Engineering
- Bachelor's degree
- SharePoint
13d
Radiotherapy Technologist - Yelahanka
Manipal Health Enterprises —Bengaluru, Karnataka
- Patient monitoring
- Bachelor's degree
- Organisational skills
Project Manager – NETI (New Enabling Technology for Independence)
The Association of People with Disability —Bengaluru, Karnataka
- ₹9,00,000 - ₹12,00,000 a year
- Full-time
- Research
- Leadership
SDET Engineer
Fortanix —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Azure
- Computer Science
- Java
- Health insurance
- Paid sick time
Quick apply
10d
Medical Auditor
Intertek —Bengaluru, Karnataka
- Full-time
- Travel
- Communication skills
Quick apply
Senior Regulatory Affairs (RA) Specialist
Healthminds Consulting —Bengaluru, Karnataka
- Full-time
- Master's degree
- Analysis skills
- Bachelor's degree
Graduate Engineer Trainee
GE HEALTHCARE —Bengaluru, Karnataka
- Microsoft Office
- Bachelor's degree
- Manufacturing
14d

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Regulatory Specialist – Medical Devices

Quest Global -
Bengaluru, Karnataka

Quick apply

Job details

Full-time

Qualifications

B.Sc
Microsoft Office
Science
Quality assurance
Bachelor's degree
Product development
Communication skills
FDA regulations

Full job description

Job Requirements

Regulatory Specialist – Medical Device

The Regulatory Affairs Specialist provides regulatory perspective and expertise to cross-functional teams to assure products can be marketed and are compliant with relevant medical device standards, codes and regulations. S/he provides medical device regulatory input to product development, product labeling, regional specific regulatory requirements, Standards & Compliance to be followed including but not limited to product labels, Instructions for Use (IFUs), Bio Compatibility, Sterilization and submission guidelines for various regions. S/he develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. S/he relies on ongoing experience and judgment to plan, create, develop, and maintain materials needed for regulatory compliance. S/he uses technical knowledge to drive new product submissions, listings, registration and identifying gaps in existing products in terms of revised regulatory needs. Trains and mentors cross functional team members in regulatory requirements Duties/Responsibilities

Develops a working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to: registration, labeling, and post-market surveillance requirements.
In alignment with applicable strategies/plans and with support of team members, determines appropriate documentation and testing required for registration of products in various regions and coordinates with functional team members to obtain and provide this information.
Closely work with customer regulatory team in preparation of technical files and coordinates data for submission.
Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action (e.g. submissions, notifications).
Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and may review and provide feedback on labeling to assure regulatory compliance.
Provides regulatory perspective to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant medical device standards, codes and regulations.
Reports relevant regulation and standards changes and helps determine impact and/or appropriate action.
Hands on EU-MDR, 510K, ISO14971:2019, RA Files, IFU, Regulatory submissions
Develops an expertise of the medical device regulations for assigned products.
Determines applicable strategies /plans for products and works with functional and cross-functional team members to create, obtain, and provide this information.
Reports relevant regulation and standards changes, determines impact and takes appropriate action.
Ensures regulatory compliance of products and processes through participation in process updates.

Qualifications

Bachelor of Science in science and/or engineering field
10-15 years of regulatory experience in medical device industry preferably experience working in OEMs.
Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards.
510(k) experience and Regulatory Affairs Certification (RAC) preferred.
Ability to support and execute activities related to product development teams and cross-functional projects.
Ability to work well with others and manage projects.
Excellent written and verbal communication skills. Proficient in Microsoft Office
Strong understanding of technical documentation requirements for medical devices (e.g., design controls, risk management, QMS).

Additional Responsibilities:

Develop and maintain relationships: Build and maintain strong relationships with regulatory agencies, including the FDA, EU Notified Bodies, and other global authorities.
Stay current on industry trends: Attend industry conferences, webinars, and workshops to stay informed about emerging trends, policies, and laws in the medical device industry.
Provide subject matter expertise: Serve as a subject matter expert for the company, providing guidance and support on regulatory affairs matters.
Collaborate with cross-functional teams: Work closely with other departments, such as quality assurance, manufacturing, and clinical affairs, to ensure a comprehensive understanding of product development and regulatory requirements.

Quick apply

Refine Your Search

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