Regulatory Affairs Specialist

21 May 2020

Regulatory Affairs Specialist

A reputable medical device organization providing medtech innovations as their forefront have reached out to us exclusively in search for two experienced headcounts in Regulatory Affairs.

Growing both organically and inorganically, this rewarding and exciting opportunity will see the RA Specialist be an all-rounder likewise assume a hybrid role in both regulatory and quality aspects

Moreover, this person would possess broad technical and commercial understanding of the entire portfolio and come up with best practises to improve current working approaches in and out of the organization

Not to mention, this function will entail the fundamentals of regulatory and quality aspects such as:

  • Providing technical and commercial insights likewise manage submission pipelines and medical device product classifications
  • Identifying regulatory document creation and supporting long-term regulatory strategies for continuous improvement
  • Being up to date with country legislations - guidelines - medical device standards, mitigating risks for existing licenses, driving product approvals and submission of dossiers
  • Sharing best practices to internal and external stakeholders to achieve consistency in product compliance
  • Working with cross functional Head of Departments and regulatory bodies together with being the subject matter expert for regulatory matters
  • Maintain good work relationships with regulatory authorities in the region and seek to influence appropriately, with the aim of achieving optimal product registrations
  • Optimize cross-functional support needs in the company, ensuring effective communication between team and with the quality, supply chain, manufacturing, marketing, legal and sales teams
  • Regulatory compliance and product registration of medical devices manufactured in company domestic sites
  • Linking and coordinating with regional, country cluster, global and functional stakeholders for the delivery of regulatory results
  • Stepping in when necessary to assist in quality and compliance initiatives

An ideal applicant would have:

  • A Bachelor's Degree in a Science or Engineering or Business-related discipline or equivalent
  • At least 3 years working experience in a similar job function and relevant industry - regulatory and quality
  • In-depth knowledge of regulatory requirements and hands on experience in submissions, product development & classifications, compilation likewise approval processes with regulatory authorities
  • A high degree of understanding of regulatory requirements & classifications, scientific methods, and engineering fundamentals
  • Experience in dealing with regulatory systems and in-house tracking system would be a plus
  • Robust & proven understanding of either cGMP, US FDA QSR, 21 CFR, EU MDD, ISO 9001 and ISO 13485
  • Ability to work in a fast paced environment and handle multiple tasks and requests.
  • Understanding of clinical trials and having worked in a R&D setting would be a nice to have
  • Proficiency in communicating strategic and tactical issues to management and stakeholders within the organization
  • Assertive, adaptable and comfortable to working in ambiguous - changing working environments

If you have what it takes, Apply now by sending us a copy of your updated CV or if you know someone suitable, we value such partnerships through our Referral Rewards Program. Do note that only shortlisted candidates will be notified

EA License No: 11C5502 | EA Reg No: R1985488

Jonathan Ong - R1985488's picture
Senior Consultant | Supply Chain & Procurement
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