Company Description Elevenclock Healthcare Pvt. Ltd. is an Indian manufacturer of premium ELEVON™ dialysis, surgical, and hospital consumables serving healthcare providers worldwide. The product portfolio includes dialyzers, bloodlines (AV sets), dialysis concentrates, IV sets, IV cannulas, fistula needles, syringes, and other critical hospital consumables. The company focuses on high-quality, reliable, and cost-effective solutions designed to support safe and efficient patient care.

Elevenclock

Healthcare collaborates closely with distributors, hospitals, and healthcare providers to meet evolving clinical and regulatory expectations. Team members join a growing organization that values quality, compliance, and long-term partnerships in the healthcare sector.

Role Description The Regulatory Affairs Specialist is a full-time, on-site position based in Ahmedabad. This role is responsible for preparing, reviewing, and maintaining regulatory documentation for medical devices and hospital consumables, ensuring accuracy and alignment with relevant standards.

The specialist will coordinate regulatory submissions to national and international authorities, track approval timelines, and support product registrations and renewals. Daily activities include monitoring regulatory requirements, interpreting changes in regulations, and advising internal teams on compliance impacts for manufacturing,



labeling, and marketing materials. The role also involves collaborating with quality assurance, production, and R&D; to address regulatory queries, support audits and inspections, and maintain organized records and reports for internal and external stakeholders.

Qualifications

- Strong expertise in Regulatory Affairs and understanding of Regulatory Requirements for medical devices or healthcare consumables.
- Hands-on experience with Regulatory Documentation and preparation of Regulatory Submissions to relevant authorities and certification bodies.
- Demonstrated ability to manage Regulatory Compliance activities, including monitoring regulatory changes and implementing necessary updates.
- Knowledge of national and international healthcare and medical device regulations (e.g., CDSCO, ISO standards, CE marking) is highly beneficial.
- Bachelor’s degree or higher in Pharmacy, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related discipline.
- Robust analytical, documentation, and organizational skills, with attention to detail and accuracy.
- Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams.
- Experience in dialysis, surgical, or hospital consumables manufacturing environments is an advantage.

📌 Regulatory Affairs Specialist (Ahmedabad)
🏢 Elevenclock Healthcare
📍 Ahmedabad