Job Description

As a Senior Regulatory Affairs Executive with a US-based company specializing in high-risk medical devices, you will have the chance to make a significant impact on the industry while being rewarded with a competitive remuneration package.

This role requires a visionary professional with exceptional skills and experience, who is also passionate about improving patient outcomes and driving innovation. Main Responsibilities

This successful incumbent will be focusing on planning and driving initiatives focused on operational excellence, playing a key role in aligning processes, facilitating rapid tactical execution of regulatory tasks and ensuring appropriate cross-functional transparency and accountability throughout the regulatory process. They should have a strong motivation and aptitude for continuous improvement.

• Anticipate regulatory and related obstacles, staying ahead of emerging issues through development of regular reviews
• Support change management in APAC
• Cross-functional collaborations with internal and external partners to identify technical solutions to translate RA processes into efficient workflows
• Develop regional technical capacity and capability, supporting product and technical file reviews
• Perform activities relating to regulatory intelligence
• Act as the Global Regulatory Information Management System (RIMS) adminsitrator and regional support within the APAC, driving initiatives and facilitating the central i action of common documents to support global registration activities and processes.
• Support continuous improvement and process alignment of regulatory operations processes, systems and documentations within APAC

Requirements

• Bachelor\'s Degree in a relevant field (e.g. Biomedical, Engineering, Life Sciences)
• At least 3-5 years\' experience in medical devices regulatory affairs
• Demonstrated fluency in regulatory processes and submissions in the APAC region
• Excellent knowledge of regulatory requirements in the US and/or EU is a plus
• Strong multi-tasking/project management skills, detailed-oriented and meticulous
• Keen eye for identifying gaps, proposing and establishing appropriate solutions for continuous improvement
• Great communicator and able to work both cross-functionally and independently

Interested Applicants

This is an unique opportunity for regulatory professionals to advance their career, delving into the operational strategy and process improvement aspect of regulatory work in additional to submission responsibilities.

Apply directly with your CV in word format and we shall get in touch shortly for a confidential discussion on this exciting 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