Regulatory Documentation Executive

Regulatory Documentation Executive – Medical Devices

Company: Laparomed Private Limited
Department: Regulatory Affairs / Quality Assurance
Designation: Regulatory Documentation Executive
Industry: Medical Devices – Laparoscopy Instruments & Equipment
Experience: 1–4 Years
Location: Mulund, Mumbai
Employment Type: Full-Time

About the Role

We are looking for a Regulatory Documentation Executive to manage regulatory and quality documentation for our range of laparoscopy instruments, surgical instruments and medical equipment.

The candidate will be responsible for preparing, maintaining and coordinating regulatory documentation related to ISO 13485, MDSAP and US FDA requirements, working closely with Quality, Production, R&D, Purchase and Management teams.

Key Responsibilities

1. Regulatory Documentation

• Prepare, review and maintain regulatory documentation for medical devices.
• Maintain Device Master Records (DMR), Device History Records (DHR) and technical documentation.
• Prepare and maintain product specifications, drawings, BOMs, labels, IFUs and product dossiers.
• Maintain document master lists, revision history and document control records.
• Ensure regulatory documents are current, controlled and traceable.

2. ISO 13485 QMS

• Support implementation and maintenance of the ISO 13485 Quality Management System.
• Prepare and maintain SOPs, Work Instructions, Forms and Quality Records.
• Support document control, change control, CAPA, NCR, complaint handling and internal audit documentation.
• Assist in maintaining risk-management and design/development documentation.

ISO 13485:2016 remains the current international medical-device QMS standard and covers requirements relevant to the design and manufacture of medical devices.

3. MDSAP Documentation

• Support preparation and maintenance of documentation required for MDSAP audits.
• Coordinate audit documentation and evidence with QA/RA teams.
• Maintain records related to management, measurement/analysis/improvement, product realization and regulatory requirements.
• Assist in closing audit observations and maintaining corrective-action documentation.

The MDSAP audit model is built around ISO 13485:2016 together with applicable regulatory requirements of participating jurisdictions.

Required Knowledge

The candidate should have working knowledge of:

• ISO 13485:2016
• MDSAP
• Medical device technical documentation

A relevant diploma/degree with medical-device regulatory experience may also be considered.

Experience

1–4 years of experience in:

• Medical Device Regulatory Affairs
• Quality Assurance / Quality Control
• ISO 13485 documentation
• MDSAP documentation
• FDA medical-device documentation
• Medical-device manufacturing

Experience with laparoscopic or surgical instruments and medical equipment will be an advantage.

Required Skills

• Excellent documentation and record-keeping skills
• Good knowledge of MS Word and Excel
• Strong attention to detail
• Good English communication and drafting skills
• Ability to understand technical drawings and specifications
• Ability to coordinate with multiple departments
• Strong document-control discipline
• Ability to work independently and meet regulatory deadlines

Key Performance Areas

• Accuracy and completeness of regulatory documentation
• Timely document preparation and revision
• Audit-readiness of QMS documentation
• Timely closure of audit observations
• Proper document traceability
• Compliance with ISO 13485, MDSAP and applicable FDA/QMSR requirements
• Maintenance of updated product technical files and regulatory dossiers

Preferred Candidate Profile

We are particularly interested in candidates who have hands-on experience preparing medical-device regulatory documentation, rather than candidates with only general administrative documentation experience.

Experience with laparoscopy instruments, surgical instruments, medical equipment manufacturing, ISO 13485 audits, MDSAP audits will be strongly preferred.

Pay: ₹30,000.00 - ₹40,000.00 per month

Work Location: In person