Regulatory Affairs Associate

Job Description – Regulatory Affairs (RA) Executive

Company: S A Orthocure Pvt. Ltd.

Department: Regulatory Affairs (RA)

Location: Changodar, Ahmedabad, Gujarat

Industry: Medical Devices / Orthopaedic Implants

Employment Type: Full-time [ 9am to 6pm ]

Total vacancy: 1

About the Company

S A Orthocure Pvt. Ltd. is a growing orthopaedic implant manufacturing company committed to delivering high-quality, precision-engineered medical devices globally. We specialize in trauma, spine, and orthopaedic implant solutions with a strong focus on quality, regulatory compliance, innovation, and customer satisfaction.

Job Summary

The Regulatory Affairs Executive will be responsible for supporting and managing regulatory activities related to medical devices and orthopaedic implants in domestic and international markets.

The role involves preparation and maintenance of regulatory dossiers, product registrations, licence applications, regulatory documentation, compliance activities, and coordination with internal departments, regulatory authorities, distributors, and international clients.

The candidate will work closely with Quality Assurance, Production, R&D, Sales & Marketing, and Export teams to ensure timely and accurate regulatory submissions and continued compliance with applicable medical device regulations.

Key Responsibilities

Regulatory Documentation & Dossier Preparation

• Prepare and maintain regulatory dossiers for orthopaedic implants and medical devices.
• Prepare technical documentation, product specifications, declarations, certificates, and supporting regulatory documents.
• Compile documents required for product registration, renewal, amendments, and regulatory submissions.
• Ensure regulatory documents are accurate, complete, current, and properly controlled.
• Maintain regulatory files and product-wise documentation.

Medical Device Registration & Licensing | Export Regulatory Support

• Support applications and registrations with regulatory authorities for domestic and international markets.
• Coordinate preparation of documents for medical device manufacturing licences, product registrations, renewals, amendments, and variations.
• Assist in regulatory submissions for international markets such as Africa, Middle East, Asia, and other export markets.
• Track registration status, licence validity, renewals, and regulatory commitments.
• Coordinate with overseas regulatory consultants for country-specific registration requirements.

Regulatory Compliance

• Monitor applicable medical device regulations, guidelines, standards, and regulatory requirements.
• Ensure products and documentation remain compliant with applicable regulatory requirements.
• Support implementation of regulatory changes within the organization.
• Maintain regulatory compliance records and submission trackers.
• Assist in responding to regulatory queries, observations, and clarification requests.

Technical & Quality Documentation

• Coordinate with QA/QC, Production, R&D, and Engineering teams for technical documentation.
• Collect and review documents.
• Support preparation and maintenance of product technical files.

Audit & Inspection Support

• Assist in preparation for regulatory inspections, audits, and customer audits.
• Coordinate required regulatory documentation during audits and inspections.
• Support preparation of responses to observations, non-conformities, and regulatory queries.
• Maintain records of regulatory inspections and corrective actions.

Regulatory Tracking & Reporting

• Maintain a regulatory database and registration tracker for all products and countries.
• Track licence expiry dates, registration renewals, amendments, submissions, and approvals.
• Prepare daily, weekly, and monthly regulatory status reports.
• Maintain proper follow-up with regulatory authorities, consultants, distributors, and internal departments.

Internal Coordination

·      Coordinate closely with: Quality Assurance / Quality Control, Production, R&D / Product Development, Sales & Marketing, Export Department, Accounts Department, Management

·      Ensure timely collection and submission of documents required for regulatory activities.

Required Skills & Competencies

• Good understanding of medical device regulatory requirements.
• Knowledge of regulatory documentation and dossier preparation.
• Strong documentation and record-management skills.
• Good knowledge of MS Word, MS Excel, and documentation/ERP systems.
• Strong follow-up and coordination skills.
• Excellent written and verbal communication.
• Ability to understand technical and regulatory documents.
• Attention to detail and accuracy.
• Ability to manage multiple regulatory projects and deadlines.
• Good analytical and problem-solving skills.

Qualification & Experience

·      Education: Graduate / Postgraduate in: Medical Devices / M.Tech Medical Devices | Regulatory Affairs | Pharmacy / M.Pharm | Any relevant pharmaceutical or medical device discipline

·      Experience: 1–3 years of experience in: Regulatory Affairs | Medical Device Regulatory Affairs | Medical Device Documentation

🌟 Freshers with relevant educational background and strong interest in Medical Device Regulatory Affairs may also apply.

Preferred Candidate Profile

• Candidates with experience in medical devices / orthopaedic implants will be preferred.
• Knowledge of Indian medical device regulations and CDSCO requirements will be an advantage and international medical device registration requirements will be an added advantage.
• Familiarity with ISO 13485 and medical device quality systems is preferred.
• Knowledge of technical documentation, risk management, biocompatibility, testing, sterilization, and clinical documentation will be advantageous.
• Willingness to learn country-specific regulatory requirements.
• Strong coordination skills with internal teams and international distributors.
• Ability to work independently and meet regulatory submission deadlines.

Salary

As per experience and company standards.

Experienced: 35/40K