Regulatory Affairs & Business Development Manager - Medical Devices (Batu Kawan)

Cureva Technologies Sdn. Bhd. is preparing the regulatory and quality-management arrangements for its planned medical-device activities in Malaysia. The Company has not commenced import or export activities in Malaysia. The intended business includes authorised representation for overseas manufacturers, product registration, importation, wholesale and distribution. Each activity will be undertaken only when its applicable legal and regulatory requirements have been met.

We are looking for an organised, responsible and practical individual who is willing to learn and actively contribute to these preparations. Extensive previous MDA experience is not essential. The Company will arrange and sponsor relevant professional training and provide external regulatory and quality management support from the beginning of employment. The initial focus will be training, licensing preparation, quality-system implementation and regulatory documentation, working with the Director and professional advisers.

Essential Appointment Requirement

Acceptance of formal appointment as the Company’s Person Responsible for MDA establishment licensing, effective from the commencement of employment, is an essential requirement of this position. The successful candidate will be appointed to the Company’s management, with genuine oversight and decision-making authority for its medical-device establishment. Responsibilities and authority will be documented in a formal appointment and delegation letter. This includes authority to address compliance concerns, require corrective action and suspend relevant activities where necessary for compliance or product safety.

The Company will assess suitability for the appointment before employment and provide immediate training and professional support. Previous appointment as an MDA Person Responsible is not mandatory. This is an active management responsibility, not a nominal appointment or a document signing-only arrangement.

Main Responsibilities:

• Professional training and licensing preparation: Undertake relevant professional training and coordinate the preparation of establishment licensing applications. Maintain document checklists, application records and deadlines. Work with the Director and appointed professional advisers to prepare accurate submissions and respond to queries.
• GDPMD and quality-system implementation :Work with external advisers to prepare, implement and maintain the applicable GDPMD quality system. Organise procedures, training records, supplier information and other supporting documents. Coordinate audit preparation and follow up on corrective actions.
• Manufacturer and product documentation: Communicate with prospective overseas manufacturing partners to obtain authorisation documents, product information and technical materials for the planned regulatory activities. Check documentation for completeness, identify missing information and follow up systematically. Prepare product-registration documentation and coordinate applications when the relevant prerequisites have been met.
• Compliance and product-safety readiness: Prepare procedures and record systems for future product traceability, distribution controls, complaint handling, safety reporting and corrective actions. Once the relevant activities commence lawfully, maintain these systems and coordinate ongoing compliance with manufacturers, the Director and professional advisers.
• Business development and trade preparation: Initially, support market research, preliminary communications with prospective manufacturers and business planning. Responsibilities involving product promotion, commercial sales, importation, wholesale and distribution will be undertaken only after the applicable regulatory requirements have been met. These responsibilities may then include customer communications, quotations, sales follow-up and business development in Malaysia and overseas.

Candidate Requirements

Candidates with a diploma, degree or equivalent relevant professional experience are welcome. Business, management, science, engineering, healthcare, quality and other relevant backgrounds will be considered.

Candidates should demonstrate:

• Good written and spoken English, with effective communication skills. Mandarin is an advantage for communication with manufacturers (China), but is not mandatory.
• Strong organisational, document-handling and follow-up skills.
• Sound judgement, attention to detail and the confidence to raise concerns.
• The ability to work responsibly in a small company and learn with professional guidance.
• Willingness to begin training immediately and accept the Person Responsible appointment as an essential part of the position.

Candidates must be domiciled in Malaysia, legally eligible to work in Malaysia and suitable for the applicable appointment requirements. Experience in medical devices, quality assurance, regulatory documentation, operations, customer coordination or international trade is advantageous. Three years of MDA-specific experience is not required. Selection will be based on practical ability, judgement, reliability and suitability for the role.

Training and Support

The Company will arrange and sponsor relevant external professional training and provide regulatory and quality-management support. The employee will receive documented authority and direct access to the Director. Technical work will be supported appropriately according to the employee’s demonstrated competence.

Salary and Benefits

Monthly basic salary of RM3,000–RM4,000, together with applicable statutory employer contributions and leave entitlements. Relevant professional training will be sponsored by the Company. Approved business expenses will be reimbursed.

Location: The 2nd and 3rd Floors of No. 1, Jalan Vervea 1  Vervea, 14110 Bandar Cassia  Pulau Pinang.