Job Description

THE ROLE

The RA&QA Executive will be responsible for regulatory compliance of IVD devices and related products according to relevant medical device regulations. Also, the RA&QA Executive will also be acting as a cross-department liaison with internal and external stakeholders, including distributors in the ASEAN region.

OVERVIEW OF KEY REPONSIBILITIES

• Responsible for preparing and submitting product registration for Class A to D IVD with health authorities in a timely manner
• Perform RA activities pertaining to product certification through renewal, licence amendments and new registration for the ASEAN region
• Work in tandem with the Global RA team, requesting support as necessary while overseeing the administration of local regulatory systems and processes
• Extend regulatory support to other departments such as marketing and sales colleagues
• In charge of QMS management and post-market surveillance activities including FSCA, CAPA, recall management and customer complaints
• Support internal and external quality audits
• Oversee quality assurance of product importation, labelling, warehouse and distribution

REQUIREMENTS

• Relevant Bachelor\'s degree e.g. Engineering, Biomedical Sciences
• At least 3-5 years\' experience in the medical devices industry with regional responsibilities
• Demonstrated success in regulatory submissions
• Knowledge of SS 620:2016 GDPMDS or ISO 13485
• RAPS certifications is an added advantage

HOW TO APPLY

This position is perfect for professionals with strong multi-tasking abilities and great inter-personal communication skills. If this sounds like you, apply directly or reach out for a confidential discussion on this awesome opportunity.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

Additional Information

Career Level

Senior Executive

Qualification

Not Specified

Years of Experience

3 years

Job Type

Full-Time

Job Specializations

,

Company Overview

Meet Integrity. We\'re a leading recruitment firm specializing in the areas of Life Sciences and Engineering with over 100 years of combined experience in the industry. We\'ve helped recruit the most prized talent in a wide variety of Life Science and Construction sectors.

With 40% of our waking time dedicated to work, we know the vital importance of how smallest actions can create the biggest impact in people\'s lives. This is exactly why our friendly team of skilled experts always prioritizes actions based on core values over personal gain.

The secret to our business is personal relationships. Because People Matter.

We\'ve been very fortunate to assist with the recruitment of some of the most talented and dynamic talent for many of the largest and smallest employers. These are businesses who were in need of elite recruits who possessed specific talents, unique skills and other technical disciplines. Reach out to us to to discover even more about how we can help you with all of your recruiting needs or your own career.

Additional Company Information

Registration No.

201634573Z

EA No.

17C8502

Company Size

1 - 50 Employees

Industry

Human Resources Management / Consulting

Benefits & Others

Miscellaneous allowance, Long hours, Formal (e.g. Shirts + Ties)

Integrity Partners