Kerja Sepenuh Masa Regulatory Affairs and Business Development Executive, Gaji tinggi MYR 4,500 di Teh Lin Prosthetic & Orthopaedic Centre Federal Territory - Maukerja

Job Summary

We are seeking a dynamic and detail-oriented Regulatory Affairs & Business Development Executive to join our team in the prosthetics and orthotics industry.

This position combines regulatory compliance and product registration responsibilities with business development and market expansion activities. The successful candidate will be responsible for ensuring our products comply with applicable medical device regulations while identifying new business opportunities, developing relationships with healthcare providers and stakeholders, and supporting the growth of the company.

The role requires an individual who is comfortable working across regulatory, commercial and cross-functional areas, with strong communication, organizational and analytical skills.

Key Responsibilities

Regulatory Affairs & Compliance

• Prepare and submit regulatory documents for prosthetic and orthotic products to relevant regulatory authorities.
• Manage and monitor product registration, approval and regulatory submission processes to ensure timely completion.
• Maintain up-to-date knowledge of applicable regulations, including MDA, GDPMD, MDR, ISO 13485 and other relevant medical device requirements.
• Prepare, review and maintain technical files, design dossiers and other regulatory documentation.
• Ensure products and internal processes remain compliant with applicable regulatory requirements throughout the product lifecycle.
• Maintain accurate and up-to-date regulatory databases and documentation.
• Conduct internal compliance reviews and support audits relating to regulatory and quality requirements.
• Liaise with regulatory authorities and relevant stakeholders regarding submissions, queries, approvals and product-related matters.
• Monitor post-market product performance, including complaints, adverse events and recalls, where applicable.
• Work closely with internal departments to assess the regulatory impact of new products, product modifications and other development activities.
• Assist in developing and updating SOPs, regulatory procedures and internal compliance processes.
• Provide regulatory updates and training to relevant internal teams.

Business Development & Market Expansion

• Identify and develop new business opportunities within the healthcare, prosthetics and orthotics sectors.
• Build and maintain strong relationships with hospitals, healthcare professionals, rehabilitation centres, insurance companies and other key stakeholders.
• Conduct market research to identify market trends, customer needs and potential business opportunities.
• Develop and execute business development strategies aligned with company objectives.
• Present and demonstrate the company's products and solutions to prospective clients and healthcare professionals.
• Attend industry events, conferences, exhibitions and other networking opportunities to promote the company's products and services.
• Identify opportunities for product diversification and the introduction of new products or solutions based on market needs.
• Gather feedback from healthcare professionals, clinicians and customers to support product improvement and future product development.
• Work closely with the Marketing, R&D and Product Development teams on promotional activities, product positioning and market opportunities.
• Support pricing strategy development by providing relevant market and competitor insights.
• Prepare regular business development, sales and market reports for management, including pipeline status, performance and market insights.
• Provide product knowledge and training to clients and relevant internal teams where required.
• Ensure business development and product distribution activities are conducted in accordance with applicable legal and regulatory requirements.

Requirements

• Minimum Bachelor's Degree in Regulatory Affairs, Biomedical Engineering, Medical/Healthcare Sciences, Business, or a related field.
• 1–2 years of experience in regulatory affairs, business medical devices, business development or the healthcare industry is preferred.
• Candidates with experience in the medical device, prosthetics and orthotics industry will have an added advantage.
• Fresh graduates with a strong interest in regulatory affairs and business development are encouraged to apply.
• Knowledge of MDA regulations, GDPMD, ISO 13485, CE marking and medical device regulatory requirements will be an advantage.
• Strong communication, interpersonal and negotiation skills.
• Strong organizational skills with excellent attention to detail.
• Ability to manage multiple projects, deadlines and stakeholders.
• Strong analytical, problem-solving and business development skills.
• Willingness to learn and work across both regulatory and commercial functions.

Language Requirements

• English – Essential
• Bahasa Malaysia – Essential
• Multilingual candidates will have an added advantage.

Transportation

• Candidates must possess a valid Driver's License and own transportation, as the position may require travelling and frequent visits to hospitals, clinics, rehabilitation centres, healthcare institutions and other business partners.

Job Type: Full-time

Pay: RM3,500.00 - RM4,500.00 per month

Benefits:

• Maternity leave
• Opportunities for promotion
• Parental leave
• Professional development

License/Certification:

• Driver's (Required)

Willingness to travel:

• 25% (Required)

Work Location: In person