Senior Manager - Regulatory, Quality & White Label

Private Advertiser; Shah Alam; On-site; MYR 240,000 - 420,000; Full time

Job summary

Private Advertiser in Malaysia seeks a Senior Manager of Regulatory Affairs, Quality Assurance and White Label to lead RAQA, OEM management and commercialisation across ASEAN markets.

You will build RAaaS offerings, manage multi-country registrations, drive product approvals, quality systems, and partner with OEMs to develop market-ready consumables for diverse healthcare sectors.

Qualifications

• Experience in multi-country medical device registrations (GDPMD, ISO 13485).
• Ability to lead RAQA and White Label product management.
• Commercial acumen to pitch services to principals.

Responsibilities

• Provide regional leadership across Regulatory Affairs and Quality Assurance.
• Oversee registrations, renewals, variations and lifecycle activities.
• Guide country teams, commercial teams and OEM partners on regulatory matters.
• Build, launch and scale RAaaS as a revenue stream.
• Lead development of our private label consumables with OEM partners.
• Develop a portfolio strategy: selection, positioning, pricing and country relevance.
• Ensure White Label offerings are differentiated and scalable.

Skills

Regulatory affairs

Quality assurance

White Label

OEM management

Regulatory submissions

Commercialisation

Leadership

MedTech familiarity

Education

Bachelor's in Biomedical Science

Bachelor's in Pharmacy

Bachelor's in Supply Chain Management

Advanced degree or regulatory certification

Job description

Senior Manager - Regulatory, Quality & White Label

As the Senior Manager of Regulatory Affairs, Quality Assurance & White Label Business, you will lead a newly consolidated strategic function within our regional corporate architecture, combining Regulatory Affairs & Quality Assurance (RAQA) with the development and commercialisation of our White Label / Private Label medical consumables portfolio.

This is a dual-mandate leadership role requiring a commercially minded RAQA professional who can operate across regulatory, quality, OEM management and commercialisation.

The role requires an entrepreneurial, highly technical leader who will drive the commercialization of our multi-country regulatory infrastructure into a revenue-generating Regulatory-as-a-Service (RAaaS) business unit for external principals. It will also oversee the development of our own house range of medical consumables, working with multiple OEM and manufacturing partners to identify, qualify and develop products that meet the regulatory, quality and commercial requirements of our target markets.

The role will also be responsible for building the White Label business as a scalable offering, enabling third-party distributors, healthcare companies and other customers to develop and commercialise their own private-label medical consumable portfolios.

Leadership & Team Structure

People Management: Lead a dedicated team covering Regulatory Affairs, Quality Assurance and White Label / Private Label product management.

Cross-Functional Collaboration: Work closely with country teams, Commercial, Procurement, Marketing, Finance and external OEM partners to take products from concept through regulatory approval and commercial launch.

Regional Coordination: Establish common standards, processes and governance for RAQA and White Label activities across the target ASEAN markets.

Activities & responsibilities supporting each area

Regulatory Affairs & Quality Assurance Leadership

Provide regional leadership across Regulatory Affairs and Quality Assurance, ensuring products and business activities comply with applicable regulatory and quality requirements across ASEAN markets.

Oversee product registration, regulatory submissions, renewals, variations, post-market requirements and other lifecycle activities.

Provide regulatory and quality guidance to country teams, commercial teams and OEM partners.

Regulatory Commercialization & RA-as-a-Service (RAaaS)

Business Unit Growth: Build, launch, and scale the commercial strategy to sell our regional regulatory capabilities as a standalone service to global medical technology principals.

Revenue Generation: Act as the primary technical point of contact to pitch, onboard, and retain third-party medical device clients looking to navigate complex ASEAN regulatory entries.

Lead the development and expansion of idsMED's own house range of medical consumables, identifying product categories with strong market potential and strategic relevance.

Develop White Label capability into a commercial service offering beyond idsMED's internal requirements.

Build a structured portfolio strategy covering product selection, positioning, pricing, market potential and country applicability.

Ensure the White Label portfolio is differentiated, commercially viable and scalable across multiple markets.

Work Experience & Qualification

Experience: 8-10+ years of progressive leadership experience in Regulatory Affairs, Quality Assurance, or Commercial Supply Chain Operations within the MedTech, Medical Device, or Healthcare Sourcing sectors.

Regulatory Expertise: Proven track record of successfully managing multi-country medical device registrations (GDPMD, ISO 13485) and dealing with regional regulatory authorities (e.g., MDA, HSA).

Experience working with medical consumables and/or OEM manufacturers.

Strong commercial acumen and the ability to translate technical and regulatory capabilities into marketable business propositions.

Mindset: An entrepreneurial "business-builder" mindset with the commercial polish required to pitch services directly to senior executive principals.

Education: Bachelor's degree in Biomedical Science, Pharmacy, Supply Chain Management, or a related discipline. An advanced degree or professional regulatory certification is highly advantageous.