Regulatory Affairs Executive

Aurolab; Madurai District; Sur place; INR 600 000 - 900 000; Plein temps

Résumé du poste

Aurolab is seeking a Regulatory Affairs Executive to ensure QMS compliance with ISO 13485:2016 across design, manufacturing and distribution. You will prepare regulatory submissions per EU MDR 2017/745 and ISO 13485:2016, and support project management to maintain compliance.

You will lead or assist audits, participate in internal/external audits, and develop CAPA actions. The role involves risk assessments, regulatory change evaluations, and global registrations (CTD/ACTD) including ROW

Qualifications

• B. Pharm degree is required.
• Minimum 2 years of experience in regulatory affairs.
• Experience with ISO 13485:2016 and EU MDR 2017/745.
• Knowledge of CTD/ACTD formats for global submissions.
• Ability to deputise RA executive in absence.

Responsabilités

• Ensure QMS fully adheres to ISO 13485:2016 across design, manufacturing, and distribution.
• Prepare and manage technical documentation for regulatory submissions (EU MDR 2017/745, ISO 13485:2016).
• Support facility project management activities to maintain regulatory compliance.
• Lead or assist audit preparation and ensure documentation is audit-ready.
• Participate in internal and external audits to demonstrate ongoing compliance.
• Collaborate to investigate nonconformities and implement CAPA actions.
• Document regulatory risk assessments and keep them up to date.
• Evaluate regulatory implications of changes to product design, processes, or QMS.
• Promote regulatory compliance awareness across departments.
• Support product registrations for ROW markets using CTD/ACTD formats.

Connaissances

QMS Compliance

Regulatory Submissions

Audit Readiness

CAPA Management

Risk Assessment

Regulatory Changes

Regulatory Awareness

CTD/ACTD Knowledge

Formation

B. Pharm

Description du poste

Role & responsibilities

• Ensure the Quality Management System (QMS) fully adheres to ISO 13485:2016 requirements across all processes, including product design, manufacturing, and distribution.


• Prepare and manage technical documentation for regulatory submissions in accordance with EU MDR 2017/745, ISO 13485:2016, and other applicable regulatory standards.


• Support facility project management activities, ensuring all related documentation and processes remain compliant.


• Lead or support audit preparation, including compilation and readiness of required documentation for internal and external audits.


• Participate in internal and external audits to demonstrate ongoing compliance with ISO 13485:2016.


• Collaborate with Quality Management and other departments to investigate nonconformities and implement effective Corrective and Preventive Actions (CAPA).


• Ensure regulatory risk assessment activities are properly documented and kept up to date.


• Evaluate and document the regulatory implications of any changes to product design, processes, or the QMS.


• Promote and maintain regulatory compliance awareness across all relevant departments


• Support and actively participate in the product registration process in accordance with CTD (Common Technical Document) and ACTD (ASEAN Common Technical Dossier) formats, as well as for Rest of World (ROW) markets.

Note: Deputation means - RA Executive is deputed and authorized to perform the RA Executive's roles in case of his absence.

Preferred candidate profile

Educational Qualification: B. Pharm

Experience: 2 Years