Regulatory Affairs Associate

Company Overview

S A Orthocure Pvt. Ltd., based in Changodar, Ahmedabad, is a rapidly growing manufacturer specializing in orthopaedic implants and medical devices. The company focuses on providing high-quality, precision-designed trauma, spine, and orthopaedic implant solutions with an emphasis on innovation, regulatory compliance, and customer satisfaction worldwide.

Job Overview

The Regulatory Affairs Associate will manage and support regulatory processes related to medical devices and orthopaedic implants for both domestic and global markets. This role requires preparation and upkeep of regulatory dossiers, product registrations, licensing applications, and related documentation. Coordination with various internal teams, regulatory authorities, distributors, and international clients will be essential to ensure timely regulatory compliance and submissions.

Primary Responsibilities

• Create and update regulatory dossiers and documentation for orthopaedic implants and other medical devices.
• Prepare technical files, product specifications, declarations, certificates, and necessary supporting materials.
• Manage product registrations, renewals, amendments, and application dossiers accurately and systematically.
• Assist in submitting documents for manufacturing licenses and product registrations for domestic and overseas markets, including Africa, Middle East, and Asia.
• Monitor registration progress, license validity, renewal deadlines, and regulatory obligations.
• Maintain liaison with international regulatory consultants to fulfill country-specific registration criteria.
• Stay informed about evolving medical device regulations and ensure company compliance.
• Coordinate with QA/QC, R&D, production, and other teams to collect and manage technical and quality documentation.
• Provide support for audits, inspections, and responses to regulatory inquiries, including preparation for non-conformity resolution.
• Maintain regulatory databases, trackers, and prepare regular status reports.
• Effectively communicate and collaborate with internal departments such as Quality Assurance, Production, Sales & Marketing, Export, and Management to ensure timely regulatory documentation submission.

Required Skills and Competencies

• Understanding of medical device regulatory frameworks and requirements.
• Proficiency in preparing regulatory documentation and dossiers.
• Strong organizational skills for managing documentation and record keeping.
• Competency in MS Word, MS Excel, and familiarity with ERP/documentation systems.
• Excellent verbal and written communication skills.
• Attention to detail and capability to handle multiple priorities and deadlines.
• Analytical mindset with good problem-solving abilities.
• Ability to comprehend technical and regulatory documentation.

Educational Qualifications and Experience

Graduate or postgraduate qualification in Medical Devices, M.Tech Medical Devices, Regulatory Affairs, Pharmacy, M.Pharm, or other relevant pharmaceutical/medical device disciplines.

1 to 3 years of professional experience in Regulatory Affairs, Medical Device Regulatory Affairs, or Medical Device Documentation.

Fresh graduates with relevant educational qualifications and keen interest in Medical Device Regulatory Affairs are encouraged to apply.

Preferred Candidate Attributes

• Experience with medical devices or orthopaedic implants is advantageous.
• Knowledge of Indian medical device regulations and CDSCO guidelines is preferred.
• Familiarity with international medical device registration processes is a plus.
• Understanding of ISO 13485 quality systems and medical device standards.
• Awareness of technical documentation areas such as risk management, biocompatibility, sterilization, and clinical data is beneficial.
• Proactive about learning diverse country-specific regulatory requirements.
• Strong coordination and independent working capability to adhere to submission deadlines.

Salary Details

Salary is aligned with experience and company policy. For experienced candidates, the monthly gross pay ranges between INR 35,000 to 40,000.

Other Information

• Work hours are full-time from 9:00 AM to 6:00 PM.
• Location of employment is Changodar, Ahmedabad, Gujarat.
• One vacancy is currently open for this position.