Senior Specialist, Quality Assurance & Regulatory Affairs (Medical Devices)

Location: Petaling Jaya, Selangor, Malaysia

Company

hirify.global develops healthcare products and supports healthcare delivery with a mission to save and sustain lives.

What you will do

• Implement local regulatory and quality activities for drugs, biologics, and medical devices.
• Develop regulatory project plans, identify regulatory risks, and provide regulatory advice to project teams.
• Prepare and submit regulatory documents, maintain marketing authorizations, and respond to regulatory authorities.
• Manage product complaints, non-conformances, adverse events, field actions, recalls, and customer quality queries.
• Oversee finished-goods release, redressing instructions, documentation control, SOPs, and GDPMD compliance.
• Manage internal, external, and supplier audits and support quality reviews through data gathering and analysis.

Requirements

• At least 5 years of relevant experience in pharmaceuticals, biologics, and medical devices in Malaysia.
• Experience with drug and medical device registration, license extensions, variations, and renewals in Malaysia.
• Knowledge of applicable regulatory laws, evolving requirements, GDPMD, GDP, and SOP compliance.
• Degree in pharmacy, science, or a related discipline is advantageous; a pharmacist license is advantageous.
• Project management, multitasking, prioritization, communication, negotiation, and compliance-risk escalation skills.
• Technical proficiency with word processing, spreadsheets, databases, and online research tools.

Culture & Benefits

• Work is guided by a mission to save and sustain lives.
• Culture emphasizes courage, trust, collaboration, ownership, accountability, and meaningful impact.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.
• hirify.global is an equal opportunity employer.