Job Description

• Fortune 500 Company
• Publicly listed company
• Medical Devices and In-Vitro Diagnostics
• Regional opportunity

MAIN RESPONSIBILITIES

You will be responsible for optimizing the approval process of product registration and identifying market opportunities by minimizing risks through regulatory expertise.

You\'ll spearhead RA/QA activities and manage product lifecycle, mitigating risks in post-marketing surveillance. Staying current with regulatory requirements is crucial as you monitor changes in regulations for relevant countries and develop regulatory and labeling plans for market introduction projects. Additionally, you\'ll ensure compliance with local regulations through comprehensive training for associates and distributors.

As a Senior RA Specialist, you\'ll enhance quality RA work by monitoring distributors\' regulatory competencies and providing effective solutions while driving business growth and maintaining compliance. You\'ll cultivate an environment of regulatory excellence, setting high standards for compliance and innovation.

REQUIREMENTS

• Bachelor\'s degree in a relevant field such as life sciences or a related discipline.
• At least 5 years\' of experience in regulatory affairs in the medical devices or IVD industry
• Knowledge of regulatory requirements in ASEAN/APAC
• Ability to work well under pressure and meet tight deadlines.
• Flexibility to adapt to changing regulatory environments and requirements.

If you\'re seeking an enriching opportunity to elevate your career in regulatory affairs with a distinguished company, I greatly encourage you to apply with your latest CV and we shall get in touch shortly for a confidential discussion.

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

Additional Information

Career Level

Senior Executive

Qualification

Bachelor\'s Degree, Post Graduate Diploma, Professional Degree

Years of Experience

5 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