Quality Assurance Regulatory Affairs Manager- Equipments

1 month ago

madurai, India Aurolab Full time

KEY RESPONSIBILITIES:


Regulatory Affairs:

·Build the technical files and drive risk management.

·Understand parts, processes and performance.

·Implement engineering change management.

·Perform regular IQA.

·Work closely with all cross-functional team members.

·Review design documents & participate in periodic design reviews.

·A weekly operating mechanism on project status.

·Boundary less involvement in new organizational initiatives


Quality Assurance:

·Capture & improve in-process yield metrics

·Final goods performance yield tracking & sustenance

·Implement non-conforming material process & resolve rework, scrap or return to

vendor

·Understand parts, processes and performance

·Implement engineering change management

·Perform regular IQA

·Face the quality audits and CAPA process

·Streamline incoming parts quality & track metrics.

·Boundary less involvement in new organizational initiatives.


Documentation and Reporting:

·Ensure all regulatory submissions, reports, and records are accurate, complete,

and maintained according to company and regulatory standards.

·Develop and maintain technical files, dossiers, and other regulatory documents

for all products.

·Prepare and present quality and regulatory reports to management.


Qualifications:

·Bachelor’s degree in a scientific, engineering, or related field. Advanced degree

preferred.

·8-12 years of experience in Quality Assurance and/or Regulatory Affairs in

[relevant industry, e.g., pharmaceuticals, medical devices].

·Thorough knowledge of relevant regulatory guidelines (e.g., FDA, EMA, ISO

standards).

·Experience with regulatory submissions and interactions with regulatory bodies.

·Strong organizational skills, with attention to detail and the ability to manage

multiple projects simultaneously.

·Excellent communication and interpersonal skills, with the ability to work

effectively in cross-functional teams.


Preferred Skills:

·Certification in Regulatory Affairs (RAC) or Quality Assurance.

·Experience with electronic quality management systems (eQMS).

·Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

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