Quality and Regulatory Manager

Private Advertiser; Iloilo City; Vor Ort; PHP 800.000 - 1.600.000; Vollzeit

Zusammenfassung

Private Advertiser in Iloilo City is seeking an experienced Quality and Regulatory Manager to join our healthcare team. This is a full-time role responsible for ensuring hospital operations, medical devices, and pharmaceutical processes comply with local and international regulatory requirements and standards.

You will lead quality management systems, manage regulatory submissions, coordinate audits, and drive CAPA actions while fostering a culture of continuous improvement across the

Qualifikationen

• Bachelor's degree in Pharmacy, Life Sciences, Healthcare Administration or related field.
• Minimum of 5 years' professional experience in quality assurance, regulatory affairs or compliance within healthcare/ Pharmaceutical sectors.
• Solid knowledge of local and international regulatory frameworks (FDA, PFDA, ISO standards).

Aufgaben

• Develop, implement and maintain quality management systems across hospital, medical device and pharmaceutical operations.
• Oversee regulatory compliance activities and monitor changes in regulations.
• Coordinate regulatory submissions and liaise with regulatory authorities.
• Conduct internal audits and quality assessments to identify areas for improvement.
• Lead CAPA investigations and drive corrective actions.

Kenntnisse

Regulatory knowledge

Quality management

Internal audits

CAPA investigations

Ausbildung

Bachelor's degree in Pharmacy

Jobbeschreibung

About us

We specialise in providing comprehensive healthcare services with a focus on quality, innovation, and regulatory compliance. Our dedicated team of healthcare professionals is driven by a mission to improve patient outcomes and advance the medical field through rigorous quality management and adherence to international regulatory standards. We pride ourselves on creating an environment where excellence is not just expected but celebrated.

About the role

We are seeking an experienced Quality and Regulatory Manager to join our team. This is a full-time position based in Iloilo City, Iloilo. In this strategic role, you will be responsible for ensuring that our hospital operations, medical devices, and pharmaceutical processes comply with all relevant regulatory requirements and international standards. You will play a crucial part in maintaining and enhancing our quality management systems, overseeing regulatory submissions, and fostering a culture of continuous improvement across the organisation. This position requires a proactive leader who can bridge the gap between clinical operations and regulatory compliance whilst driving organisational excellence.

Key responsibilities

• Develop, implement, and maintain comprehensive quality management systems that comply with relevant pharmaceutical, medical device, and healthcare regulations

• Oversee regulatory compliance activities, including monitoring changes in local and international regulations and ensuring timely implementation across the hospital

• Manage regulatory submissions, documentation, and liaison with regulatory bodies and authorities

• Conduct regular internal audits and quality assessments to identify areas for improvement and ensure adherence to established standards

• Lead root cause analysis investigations for non-conformances, adverse events, and complaints, implementing corrective and preventive actions (CAPA).

What we're looking for

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, Healthcare Administration, or a related discipline

• A minimum of 5 years' professional experience in quality assurance, regulatory affairs, or compliance within the pharmaceutical, medical device, or healthcare industry

• Demonstrated knowledge of relevant local and international regulatory frameworks, including FDA, ISO standards, and Philippines Food and Drug Administration (PFDA) regulations