Senior Regulatory Affairs Specialist (RE-33907794)

Location: Singapore    |  Remote Working Available
Salary: competitive
Job Type: Contract
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I am currently looking for a Senior Regulatory Affairs Specialist for one of my Global Medical Devices MNC client in Singapore.

Location: Central, Singapore
Title: Senior Regulatory Affairs Specialist

Responsibilities:

  • Participate and coordinate in the development of regulatory strategies, in conjunction with the needs of the company, for each product range and change. Establish regular review with Sales & Marketing and other relevant stakeholders to ensure the strategies are in alignment with company needs and marketing strategy.
  • Identify risks and/or changes to the strategies (if any) and involve the relevant stakeholders for discussion on action plan.
  • Liaise with the necessary parties, BU RA, registration agency, distributors, sales & marketing and other relevant stakeholders, to understand and evaluate the requirements for product registrations for designated market.
  • Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of submissions for new products, amendment/variation of approved products and submissions that support the maintenance of existing licenses. Review the technical documents obtained from different source before submission to external party and/or authority to ensure the documents meet and/or fulfill the country requirement/request. Ensure the documents are legalized and/or notarized where required
  • Support QA on SS620/GDPMDS audit and related activities in the region.
  • Participate and coordinate in the labeling artwork and Instructions For Use (IFU) preparation (include translations to the required foreign languages), review and approval activities for new and/or modified products.

Requirements:

  • 5 years of experience in Regulatory Affairs in the Medical Industry
  • Regional SEA experience preferred
  • Experience within Medical Devices GMPMDS advantageous

Real is a trading division of SThree Pte Limited

(Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

As per Ministry of Manpower (MoM) requirements, if you're suitable for any roles that we will be putting you forward for, we will need to request for your identification number. Please be assured that this will not be disclosed with our client or any other parties other than MoM.

Award winner of:

Recruitment Agency of the Year by Asia Recruitment Awards 2019 | Best Overseas Operation by Global Recruiters 2017 | Highly Commended for Best Large Recruitment Business 2017 | Commended for Best In-House Training by Global Recruiters 2017 | International Recruitment Company of the Year by Recruitment International 2016 | Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016



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