Oivi is hiring for the position of QARA Executive at its Bengaluru office. This is a hybrid opportunity for professionals with 1–3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.

The Oivi QARA Executive role combines medical device Quality Assurance, Regulatory Affairs, ISO 13485 QMS, technical documentation, CAPA, risk management, document control, and regulatory compliance responsibilities. Candidates from Pharmacy, Life Sciences, Biomedical, Biotechnology, Engineering, and related backgrounds can apply if they meet the required experience criteria.

For professionals searching for medical device QARA jobs in Bengaluru, Quality Assurance jobs in medical devices, Regulatory Affairs jobs in Bangalore, or ISO 13485 jobs in India, this opportunity offers exposure across both QA and RA functions.

Oivi QARA Executive Job Overview

About Oivi

Oivi is a medical technology company founded in 2017 with a mission to make eye screening more accessible. The company develops solutions focused on improving access to eye screening and currently has a growing team of more than 40 colleagues.

The QARA Executive at Oivi will support the company’s Quality Management System, technical documentation, regulatory documentation and medical device compliance activities.

Key Responsibilities

Quality Management System – QMS

As a QARA Executive, the selected candidate will support the maintenance and continuous improvement of Oivi’s medical device Quality Management System.

Key responsibilities include:

• Maintain and support the Quality Management System in accordance with ISO 13485 requirements.
• Prepare, review, revise and maintain SOPs, procedures, work instructions, forms and templates.
• Ensure appropriate document and record control, including version control, traceability, archival and obsolescence management.
• Conduct document release checks and proofreading before controlled documents are released.
• Verify document numbering, revisions, formatting and completeness.
• Support CAPA, NCR, customer complaints, deviations, change controls and risk management activities.
• Monitor QMS performance metrics and contribute to continuous quality improvement.
• Coordinate internal quality training activities with HR.
• Maintain appropriate training records.
• Work with cross-functional teams to ensure quality records are completed and maintained.
• Support internal and external audits.

Design & Technical Documentation Responsibilities

The QARA Executive will also work with design and development teams on medical device technical documentation.

Responsibilities include:

• Assist with preparation and review of design verification and validation documentation.
• Support preparation and maintenance of medical device technical documentation and technical files.
• Identify documentation gaps against applicable regulatory requirements and standards.
• Support medical device risk management documentation.
• Coordinate with relevant teams to maintain compliant design and development documentation.

Regulatory Affairs Responsibilities

The position also provides exposure to medical device Regulatory Affairs activities.

The candidate will:

• Support medical device regulatory submissions and product registrations in applicable markets.
• Maintain regulatory submission records, approvals and licenses.
• Monitor changes in medical device regulations and evaluate potential impact on existing products and processes.
• Support Unique Device Identification (UDI) compliance activities.
• Maintain UDI-related documentation and records.
• Coordinate with regulatory authorities, notified bodies, consultants and internal stakeholders.
• Assist in maintaining compliance with applicable medical device regulations and standards.

Qualification & Eligibility

Candidates interested in the Oivi QARA Executive job should have:

• Bachelor’s degree in Engineering, Life Sciences, Biomedical, Pharmacy, Biotechnology, or a related discipline.
• 1–3 years of experience in Quality Assurance and/or Regulatory Affairs in the medical device industry.
• Mandatory hands-on experience working with an ISO 13485 Quality Management System.
• Understanding of medical device document control processes.
• Knowledge of CAPA, NCR and complaint handling.
• Understanding of risk management processes.
• Experience managing technical and QMS documentation.
• Exposure to internal and external audits.
• Good written and verbal communication skills.
• Strong coordination and documentation abilities.

Key Skills Required

Important skills for this medical device QARA job include:

ISO 13485 | Medical Device QMS | Quality Assurance | Regulatory Affairs | Document Control | CAPA | NCR | Complaint Handling | Technical Documentation | Risk Management | Audit Support | Design Control | Cross-functional Coordination | Microsoft Office

Nice-to-Have Skills

Candidates with exposure to the following areas may have an additional advantage:

• U.S. FDA medical device regulations
• CDSCO medical device requirements
• European Commission regulatory requirements
• UDI compliance
• Medical device design control documentation

Who Should Apply?

This opportunity is particularly relevant for professionals currently working as:

QARA Executive, QA Executive – Medical Devices, Regulatory Affairs Executive, Quality Assurance Executive, QMS Executive, Medical Device Regulatory Affairs Associate, Quality & Regulatory Executive, or ISO 13485 Quality Executive.

Candidates should note that ISO 13485 QMS experience is specifically listed as mandatory. Therefore, applicants with only pharmaceutical QA experience and no medical device/ISO 13485 exposure may not closely match the stated requirements.

Why Consider This Opportunity?

The Oivi QARA Executive position offers the opportunity to work across both Quality Assurance and Regulatory Affairs rather than being restricted to a single QARA activity.

The role provides practical exposure to:

• Medical device QMS
• ISO 13485 compliance
• CAPA and NCR processes
• Complaint handling
• Risk management
• Technical documentation
• Design verification and validation documentation
• Regulatory submissions
• UDI compliance
• Internal and external audits
• Global medical device regulatory requirements

This combination can be valuable for professionals seeking to develop a broader career in medical device Quality Assurance and Regulatory Affairs.

Estimated Salary

Oivi has not specified a salary range in the provided job description.

For structured job information, a reasonable market estimate for a QARA Executive with 1–3 years of medical device experience in Bengaluru is approximately ₹4,00,000–₹8,00,000 per year.

Note: This is an estimated market range and is not an officially disclosed Oivi salary. Actual compensation may vary depending on experience, skills, current compensation and company policy.

How to Apply

Application Link