Regulatory Affairs Executive – Synthes Singapore Pte Ltd
Synthes Singapore Pte Ltd
Synthes is a U.S.-based, leading global medical device company. We develop, produce and market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the skeleton and its soft tissues. We are present in every continent of the world and employ about 9000 people.
We are currently seeking self-motivated and dynamic individuals for the following positions:
Regulatory Affairs Executive
The job:
Ensure appropriate licensing and legal compliance
Advise and co-ordinate approval and registration of products
Liaise with Sales and Marketing team on product launches relating to registration
Ensure products comply with the regulations of relevant authorities
Keep abreast of international legislation, guidelines and customer practices; collecting and collating a wide range of information
Keep up to date with the company's product range
Develop and write clear arguments and explanations for new product licenses and license renewals
Prepare submissions of license variations and renewals
Set timelines for license variations and renewal approvals
Understand and evaluate complex information
Advise manufacturers on regulatory requirements
Resolve complex issues as they arise
Prepare and coordinate documentation
Undertake and manage regulatory inspections
Review company practices and provide advise on changes to systems
Liaise with, and make presentations to, regulatory authorities
Submit license and/or any other required applications to authorities to strict deadlines
Negotiate with regulatory authorities for marketing authorization
Specify storage, labeling and packaging requirements
Liaise closely with regulatory authorities on a regular basis



















































