Job Description

Position: Senior / Regulatory Affairs Executive

Company: US HQ, IVD MNC

In this role, you will develop and implement efficient regulatory strategies and processes to ensure timely product registration, life cycle management, and post-market activities.

The successful candidate will possess exceptional negotiation and facilitation skills, as well as the ability to communicate effectively and promote productive discussions and collaborations across various departments. Strong time and project management skills, coupled with a keen eye for detail, are also highly valued in this role.

Job Responsibilities:

• Develop solutions to regulatory pre-market activity issues
• Prioritize product registration to identify potential market opportunities and reduce regulatory approval risks
• Facilitate communication and coordination among global, HQ RA, and manufacturing sites\' RA
• Drive RA/QA activities to ensure timely product registration and life cycle management
• Monitor regulatory changes to maintain up-to-date knowledge of requirements
• Develop consistent regulatory and labeling plans for new products
• Train Company associates and distributors on local regulations and ensure compliance
• Ensure distributor\'s regulatory competencies meet quality standards
• Maintain compliance with local requirements while supporting business growth
• Cultivate a culture of regulatory excellence throughout the Company

Job Requirements:

• Bachelor\'s degree in pharmaceutical, life sciences, or biomedical engineering fields
• At least 3 - 5 years of experience in regulatory affairs, including product registration and license maintenance for medical devices
• In-depth knowledge of regulatory practices, particularly in the APAC/ASEAN region.

If you\'re looking to advance your regulatory affairs career, please submit your most recent CV for consideration, and we will contact you for a confidential discussion on this excellent 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