Raqa Specialist

Position Summary
The R A / QA s p ecialist i s r e s p o n si b le f o r reg u la t o r y c o m p lia n ce o f I V D and Life Science p r o du cts i m p o r t e d by L eica Bios y st e m s ac c o r d i n g t o HSA medical device regulations and o ther r ele v a n t l o cal reg u lat i o n s. I n ad d iti o n, this position is respo n si b le for liaison between Leica Biosystems business unit and SEA region distributors on all RAQA matter.
Key Responsibilities
Regulatory affairs
Follow Health Product (Medical Device) Regulation by HSA and other relevant regulations related to products of Leica Biosystems and provide directions for compliance to the organization.
Perform IVD Product registration (Class A to D) with HSA in time and in accordance with the global product launch schedule and local launch plan.
Effective operate regulatory pathway for medical devices in SEA region (Singapore, Malaysia, Thailand, Indonesia and others)
Manage product certification through renewal, license amendments and new registration
Communicate and align with the global regulatory team to get support for local product registration and manage local regulatory systems and processes.
Provide regulatory support to marketing, sales and FSE.

Quality assurance
Establish, manage, maintain, and update quality policies and standards for LBS Singapore
Manage a post-market surveillance i.e. CAPA, FSCA, Recall, and Customer complaints.
Prepare and respond to quality audits conducted by the global and notified body.
Define the process for product import, warehousing, labeling and delivery to ensure sustained quality of products sold.

Required Education, Experience, Skills
Minimum 5 y e a r s of e x pe ri e n c e in r e g u la t ory affairs for SEA region a nd /or qu ali t y ass u ra n ce f i e ld
Bachelor’s degree or higher (Bio, Chemical) or Medical device certification or RAPS
Proficient and In-depth knowledge for ASEAN Medical Device Regulation and ISO13485
Good skilld of MS Office (Excel, Access)
G ood c o mm a n d and communication skills in En gli s h

Personal Trait Profile
Highly organized, process-orientated and adhering to the standard process.
Exhibit good leadership across departments and teams.
Good time management and project management.
Collaborative and a team player
Good interpersonal, listening and communication skill.
A high degree of integrity, discrete and honest

Key Relationships
Internal
RAQA manager-APAC
Quality board consisting of logistics, service and marketing managers
RA/QA associates in the Global registration team and manufacturing sites

External
HSA and distributors and other relevant Authority

Physical Demands & Working Environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.