Job Description

THE OPPORTUNITY

An esteemed Medical Devices Company is currently seeking a highly capable Regulatory Affairs Specialist to join their team. The successful incumbent will be tasked with the development and implementation of efficient regulatory strategies and processes, ensuring timely product registration, life cycle management, and post-market activities.

The ideal candidate should 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. RESPONSIBILITIES * Offer business units solutions for regulatory pre-market activity issues and foster partnerships for effective implementation and resolution.

• Identify potential market opportunities by influencing and prioritizing product registration while reducing regulatory approval risks.
• Ensure effective communication and coordination between global, HQ RA, and manufacturing sites\' RA for successful implementation of strategic plans.
• Lead and drive RA/QA activities to ensure timely registration of products or life cycle management, and mitigate post-marketing surveillance risks.
• Monitor relevant countries\' regulatory changes to stay up-to-date on regulatory requirements.
• Develop regulatory and labeling plans for consistency and guidance during market introduction projects.
• Provide training and knowledge sharing sessions to Company\'s associates and distributors to ensure compliance with local regulations.
• Monitor distributor\'s regulatory competencies and provide effective solutions for quality RA work.
• Maintain compliance with local requirements while driving business growth.
• Foster a culture of regulatory excellence throughout the Company.

EDUCATION AND EXPERIENCE NECESSARY

• A science degree related to the pharmaceutical, life sciences, or biomedical engineering fields is required.
• 1 to 3 years of experience in regulatory affairs, specifically in handling product registration and license maintenance for medical devices.
• Comprehensive understanding of regulatory practices, particularly in the APAC/ASEAN region.

Looking to advance your regulatory affairs career? Quickly apply with your most recent CV and we will connect with you shortly for a confidential discussion on this excellent opportunity.

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

Additional Information

Career Level

Junior Executive

Qualification

Not Specified

Years of Experience

1 year

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