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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 device quality and regulatory matters as needed. Will be assigned as key auditee during external audits as necessary
- Oversee CAPA meetings and management of effective CAPA implementation
- Provide regulatory guidance and support to internal teams and stakeholders. This includes communicating changes in regulations,

conducting training on quality and regulatory requirements, and fostering a culture of compliance within the organization

➢ Risk:

- Collaborate with the Risk Management Team to support the assessment and mitigation of risks associated with product quality and regulatory compliance. This involves identifying potential risks throughout the product lifecycle and implementing effective strategies to minimize or eliminate them
- Ensures consistent RM reports are available for all products
- Provides oversight on risk assessments, including post-market evaluations





➢ Post Market Surveillance:

- Develop, revise, manage and administer PMS plans, conduct reviews and reports as required by department manager and in accordance with approved procedures
- Provide support for PMS activities on relevant product data requirement

SKILLS &

RESPONSIBILITIES

- Minimum 5+ years QA or regulatory experience in medical industry
- Bachelor’s degree in biomedical engineering discipline or equivalent engineering degree
- Working knowledge of appropriate global medical device regulations, requirements, and standards, such as ISO 13485, 21

CFR Parts 803, 806, and 820, ISO14971, European Medical Device

Directive (93/42/EEC), EU MDR (2017/745)

- Has wide-range experience, uses skilled concepts and company objectives to resolve complex issues in creative and effective ways
- Experience interacting with the FDA, and Other Regulatory

Authorities

- Good time-management skills
- Strong English verbal and written communication skills

Demonstrate strong critical thinking skills to evaluate and investigate customer complaints, determining the need for CAPA and MDR

- Show willingness and ability to learn new processes and suggest options for compliance and efficiency
- Excellent Analytical skills and ability to synthesize trending data into meaningful information for the organization
- Demonstrate leadership; attention to detail and ability to solve problems and communicate issues;
- Ability to work on multiple projects and to learn and implement company policies, procedures, and work instructions

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