Job Description:

POSITION TITLE: Senior QA/RA Specialist
JOB LOCATION: Bangalore,India
DEPARTMENT: Quality & Regulatory
REQUIRED EDUCATION: Bachelor’s degree in biomedical engineering discipline or equivalent

engineering degree
KEY RESPONSIBILITIES: ➢ Product QA/RA:

• Provide quality and regulatory affairs input to the product
development team and handle all QA & RA responsibilities
throughout product development, design change and post market
surveillance process
• As part of core team, work with engineering team to ensure
Project team follows Quality system and PRD process, appropriate execution, and documentation of design control activities (e.g.,
Design Inputs, Design Outputs, Design Verification)
• Plan and support project milestone reviews
• Provide the engineering and manufacturing team with the relevant
quality and regulatory affairs requirements as part of Product
Design Inputs for further product development and process
validation requirements
• Lead regulatory submissions in alignment with guidance from your
supervisor




• Support in discussions with regulatory auditors regarding medical
device quality and regulatory matters as necessary
• Demonstrate attention to detail, flexibility, and awareness of
production and quality control issues
• Responsible for ensuring that product labeling and packaging
comply with regulatory requirements, including accuracy of
information, proper use of symbols, and adherence to labeling
guidelines and approve the labelling requirement and plan as
assigned
➢ QMS (Quality Management System) Management:
• Be responsible for establishing approved documents, maintain and
continuously improve Quality System processes required by
international, regional and national regulatory authorities and
standards e.g., 93/42/EEC, Regulation (EU) 2017/745,
ISO13485:2016, FDA QSR))
• Establish and analyze key performance indicators to evaluate
and continuously improve the QMS
• Lead discussions with regulatory auditors regarding medical dev

📌 QA/RA Specialist (Bengaluru)
🏢 3G HR Services
📍 Bengaluru