Regulatory Affairs (Healthcare, Compliance, Regulatory Training) #HVW

Regulatory Affairs (Healthcare, Compliance, Regulatory Training) #HVW

Singapore | Posted: Nov 05, 2024

Responsibilities

• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
• Provides technical guidance and regulatory training/mentoring to cross-functional teams.
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
• Develops and implements regulatory strategies for new and modified products.
• Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
• Establish and support a work environment of continuous improvement that supports Quality Policy, Quality System and the appropriate regulations for the area they support.
• Ensures appropriate training is maintained to do the work and training is documented.

Requirements

• Min Deg in any discipline
• 1-2 years in regulatory affairs will be advantageous
• Meticulous and efficient
• Knowledge of Microsoft Excel

If you are interested in this position, please send your most updated resume to victoriayam@recruitexpress.com.sg.

Thank you.

Victoria Yam Wen Ting
R21103142
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599