Company Description

C Cube Advanced Technologies is an innovative organization specializing in cutting-edge solutions in the healthcare and medical equipment industry. Focused on advancing technology and improving healthcare standards, the company is committed to delivering high-quality products that enhance patient care. Based in Bengaluru, C Cube fosters a culture of excellence, innovation, and collaboration. Joining C Cube means being part of a team dedicated to making a meaningful impact in the healthcare sector.

Role Description

This is a full-time hybrid role based in Bengaluru, with the flexibility to work remotely as needed. As a Regulatory Officer for Healthcare Medical Equipment, you will oversee regulatory compliance and ensure the company adheres to legal requirements specific to the medical device industry. Key responsibilities include preparing and managing regulatory documentation, ensuring alignment with compliance standards, reviewing and implementing regulatory requirements, managing regulatory submissions, and staying updated on relevant regulatory affairs. You will collaborate with cross-functional teams to support product development and ensure regulatory readiness.

Qualifications

• Proficiency in Regulatory Documentation and Regulatory Submissions
• Expertise in ensuring Regulatory Compliance and meeting Regulatory Requirements
• Knowledge of Regulatory Affairs within the healthcare or medical equipment industry
• Strong organizational and attention-to-detail skills
• Ability to assess and analyze legal and health-related regulatory frameworks
• Bachelor's degree in a relevant field such as Biomedical Engineering, Regulatory Science, or a related discipline
• Prior experience in the healthcare or medical device industry is advantageous

Regulatory Officer – Medical Equipment / Healthcare Industry

Job Title: - Regulatory Officer – Medical Devices & Healthcare Equipment

Job Summary

We are seeking a detail-oriented and proactive Regulatory Officer to ensure compliance of medical equipment and healthcare products with applicable national and international regulatory requirements. The ideal candidate will manage regulatory submissions, maintain compliance documentation, coordinate with regulatory authorities, and support product registration and market access activities.

The role requires strong knowledge of medical device regulations, quality standards, and healthcare compliance processes.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for medical devices and healthcare equipment.
• Ensure compliance with applicable regulations, standards, and guidelines including:
• FDA regulations
• EU MDR/IVDR
• ISO 13485
• CDSCO and Indian Medical Device Rules (where applicable)
• Coordinate product registration, renewals, and approvals with regulatory authorities.
• Maintain technical files, device master records, and regulatory databases.
• Monitor changes in healthcare and medical device regulations and assess business impact.
• Support audits, inspections, and compliance assessments.
• Collaborate with Quality Assurance, R&D, Manufacturing, Clinical, and Marketing teams.
• Review product labeling, packaging, IFUs, and promotional materials for regulatory compliance.
• Assist in post-market surveillance activities, adverse event reporting, and vigilance reporting.
• Ensure timely submission of licenses, certifications, and regulatory renewals.
• Prepare SOPs and internal regulatory compliance procedures.
• Provide regulatory guidance during new product development and product modifications.

Required Qualifications

• Bachelor’s degree in:
• Biomedical Engineering
• Pharmacy
• Life Sciences
• Biotechnology
• Regulatory Affairs
• or related field
• 2–7 years of experience in regulatory affairs within the medical device or healthcare equipment industry.
• Strong understanding of medical device regulatory frameworks and quality systems.
• Experience with regulatory submissions and documentation management.
• Familiarity with ISO 13485, risk management, and clinical evaluation processes.
• Excellent documentation, analytical, and communication skills.
• Ability to manage multiple projects and deadlines effectively.

Preferred Qualifications

• Certification in Regulatory Affairs (RAC or equivalent) preferred.
• Experience with international product registrations.
• Knowledge of CE marking and UDI requirements.
• Exposure to software-enabled medical devices or digital health products is an advantage.

Key Skills

• Regulatory Compliance
• Medical Device Regulations
• Documentation Management
• FDA / EU MDR / CDSCO
• ISO 13485
• Audit Coordination
• Technical Writing
• Risk Assessment
• Attention to Detail
• Cross-functional Collaboration

Working Conditions

• Office-based with coordination across manufacturing and quality teams.
• May require interaction with regulatory authorities, auditors, and certification bodies.
• Occasional travel for audits, inspections, or training.

Employment Type

• Full-Time

Department

• Regulatory Affairs / Quality & Compliance

Reporting To

• Senior Manager / Head of Quality & Compliance / Operations Head

Location

C Cube Advanced Technologies

#406, 3rd Floor, Malnad Residency, 4th Main road, Hanuma Hills Layout,

Banashankari 3rd stage, Bangalore , Karnataka 560061

Phone = 9611111273 / / 080-43021028

Office Location @ https://maps.app.goo.gl/2L9e68EhAADC144bA

How to Apply

Send your updated resume, portfolio, and social media/work samples to:

marketing@ccubeadvtech.com & info@ccubeadvtech.com

Once your resume is shortlisted we shall call you for a personal interview at our office location or through virtual interview on google meet or Teams video call based on your location.