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

We are looking for a person who:

• Degree in Science or relevant field
• Minimum 2-3 years of Regulatory Affairs experience
• Regulatory experience in medical device preferred
• Is a Singaporean or Singapore PR

If you are keen to take up this challenge, you may e-mail/mail to: The General Manager, Synthes Singapore Pte Ltd, 101 Thomson Road #10-03/04 United Square Singapore 307591, your application together with your resume detailing your qualifications, working experience, current & expected salaries, and a recent non-returnable photograph by 15 January 2009. Only short-listed candidates will be notified.

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