Senior Regulatory Affairs Specialist

Andaman Medical; Kuala Lumpur; Presencial; MYR 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Meaningful work

Regional exposure

Professional growth

Inclusive culture

Descripción de la vacante

Andaman Medical seeks a Senior Regulatory Affairs Specialist to drive regulatory best practices and lead end-to-end submissions for medical device clients. The role requires navigating MOH registration pathways, liaising with authorities, and ensuring timely approvals across Southeast Asia.

You will monitor regulatory developments, prepare intelligence reports, and support sales with regulatory discussions.

Formación

• Requires strong organizational and project management abilities.
• Proven stakeholder management experience.
• Fluency in written and spoken English and Mandarin.

Responsabilidades

• Lead end-to-end regulatory submissions for medical device clients.
• Determine MOH registration requirements and submission routes for health products.
• Manage regulatory inquiries and liaise with authorities and clients.
• Develop and maintain regulatory SOPs and compliance policies.
• Monitor regulatory trends and provide updates to Marketing and Sales teams.

Conocimientos

Organizational skills

Project management

Stakeholder management

Educación

Bachelor's degree or higher in biology/chemistry/pharmacy/biotechnology

Descripción del empleo

About the Role

This role requires a high degree of autonomy to support Andaman Medical’s regulatory goals and client commitments. The Senior Regulatory Affairs Specialist will drive best practices within the team to maximise efficiency, lead end-to-end regulatory submissions for our medical device clients, and stay on top of evolving global and regional regulatory standards.

Key Responsibilities

• Determine whether health products qualify as medical devices requiring registration with the Ministry of Health (MOH), including risk classification and appropriate submission routes.
• Prepare, submit, and manage applications for Initial registrations, Renewals, and Change Notifications, following through until final approval.
• Promptly notify manufacturers of any Authority queries or feedback to ensure successful product registration.
• Act as a key liaison for clients to address and resolve regulatory inquiries.
• Maintain the company’s internal regulatory database and tracking tools.
• Research and compile Regulatory Intelligence Reports on emerging regulatory topics.
• Monitor regional and international regulatory trends, evaluate their impact on ongoing projects, and prepare regulatory updates for the Marketing team.
• Support the Sales team during technical discussions with clients on regulatory requirements as needed.
• Develop and maintain SOPs, local working guidelines, and regulatory compliance policies.
• Liaise with authorities and external stakeholders on medical device compliance matters.
• Manage post-marketing surveillance reporting with authorities (mandatory problem reporting, field safety corrective actions, recalls, etc.).
• Ensure ongoing compliance with statutory regulations and internal leadership directives.

What We Are Looking For (Requirements)

• Education: At least a Bachelor’s Degree, Post-Graduate Diploma, Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent. Graduated as pharmacist/apothecary.
• Experience: Minimum of 5 years of regulatory affairs experience in medical devices and/or IVD’s, food supplements, and cosmetics.
• Skills: Strong organisational, project management, and stakeholder management skills.
• Languages: Professional working fluency in written and spoken English and Mandarin.

What We Offer

• Meaningful Work: Direct involvement in bringing life-saving medical devices and healthcare technologies to market.
• Regional Exposure: Collaborative work environment with cross-border teams and local in-country experts across Southeast Asia.
• Professional Growth: Opportunities for continuous learning as regional healthcare regulations evolve.
• Inclusive Culture: A supportive team culture guided by our RICE values (Responsibility, Integrity, Collaboration, Energy).