Regulatory Affairs Specialist (1 Year Contract/Up to $7000)
The Impact You’ll Make in this Role
As a Regulatory Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Primary Responsibilities include but are not limited to the following:
· Prepare Technical Documentation for Consumer Health products for use in Singapore and Malaysia
· Assure that all device listings, import licenses, and registrations for Consumer Health products are accurate and up to date
· Review product labeling and claims for compliance to applicable regulations
· Represent Regulatory Affairs on multidisciplinary project teams including New Product Introductions and Change Management Projects
· Provide local QMS, Distribution Quality assistance, audit support as required
· Communicate with regulatory authorities regarding regulatory affairs matters such as product registrations, changes in existing products and renewals.
· To handle, manage, communicate and follow up with stakeholders on and field safety notice action or related matters.
· Develop or maintain regulatory database and record as required.
· Participate and provide support within APAC Regulatory
· Ensure compliance with applicable regulatory requirements including those pertaining to product safety and post-market surveillance / vigilance
· Assist with other Asia related regulatory tasks as assigned
Your Skills and Expertise
To set you up for success in this role from day one, we require (at a minimum) the following qualifications:
1. Bachelor degree (completed and verified prior to start) from an accredited institution with relevant technical degree.
2. Minimum three (3) years of combined experience in quality assurance and regulatory compliance. High preference for experiences in consumer medical device product registrations.
3. Must be experienced in product registrations according to Singapore HSA regulations for medical devices. High preference for candidate to also have experience in product registrations according to Malaysia’s MDA regulations for medical devices.
4. Familiar with ISO13485 quality management systems and GDPMDS. High preference for candidate with experience in supporting quality audits.
5. Demonstrable effective cross-functional and intercultural working experiences in a global company.
6. Good English-speaking skillsets and proficient in Microsoft Office Tools.
7. Demonstrated ability to support technical efforts, with proven experience collaborating effectively with cross functional team members
8. Ability to multitask and prioritize personal workload to meet deadlines
9. Strong verbal and written communication skills with ability to provide diligent, concise and fact-based communication to Executive Management and cross functional peers
10. Strong attention to detail and good organizational skills.
EA License No. 01C4394 • RCB No. 200007268E •EA Registration No. R22109454 Malcolm Lee Jun Hao
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