Regulatory Affairs Specialist

A leading medical device company is advertising a vacancy for a Regulatory Affairs Specialist to be based in their office in Singapore. The company develops and manufactures in vitro diagnostic instruments, reagents and software. This is an exciting opportunity to work with a prestigious establishment and bolster a career in the regulatory field.

Job Responsibilities:

• Prepare & submit product registration documentation & other relevant licences' application.
• 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.
• Assist 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.
• Knowledge on the regulation of other than In-vitro medical device types, e.g., software, general medical device, POC will be an advantage.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

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 contact Cherry Medrano at + 6531593197 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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EA Licence No.: EA13C6865

Registration No: R1110739