Regulatory Affairs Specialist

Proclinical is seeking a Regulatory Affairs Specialist to be based in Singapore on a permanent basis. This role will entail dossier preparation & product registration submission to HSA, leading to timely introduction of new products and responsible for supplemental filings for any changes, along with assisting in data/information gathering & dossier compilation for product registration submission & other related licenses for the company's Asia Pacific affiliates & distributors including progress monitoring & follow-ups.
You will also provide regulatory support, update, advisory & knowledge sharing to the company & it's affiliates and distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific

Job Responsibilties:

• Prepare & submit product registration documentation & other relevant licences' application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Singapore
• Notify and update Health Science Authority (HSA) of any change of particulars / documents related to product registration
• Manage adverse event and field safety corrective action reporting to HSA within the stipulated timeline
• Ensure changes to the approved products are timely submitted to HSA as required
• Maintain product approvals and dealer's licences
• Maintain product registration record and product registration database to ensure proper documentation and record filing
• Maintain the knowledge and awareness of current applicable regulations and standards
• Support business partners in new product registration, renewals and amendments;
• Support Sales, Marketing and SCM in all regulatory related areas
• Assisting the AP affiliates & distributors in data/information gathering from manufacturers, drafting/assisting in preparation of initial dossier for submission
• Maintain product registration record and product registration database to ensure proper documentation and record filing for all affiliates and business partner countries
• Maintain the knowledge and awareness of current applicable regulations and standards for all affiliates and business partner countries
• Support business partners in new product registration, renewals and amendments
• Support Sales & Marketing and SCM in all regulatory related areas

Skills and Requirements:

• Diploma in Medical Science or equivalent
• Min 4-5 years' experience in regulatory affairs in IVD or medical devices
• Medical Device Act & other medical device related regulations in Singapore and other AP countries
• Basic computer knowledge & application, e.g. Microsoft Office, Power PDF, etc
• Responsible, team player, keen to learn
• Knowledge on the regulation of other than In-vitro medical device types, e.g., software, general medical device, POC will be an advantage

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mandy Fang on +65 3159 1467 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

R1215238

EA13C6865