Regulatory Affairs Officer

3 weeks ago

Kuala Lumpur, Kuala Lumpur, Malaysia Alivedx Full time

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

Regulatory Affairs officer

AliveDx is recruiting for a Regulatory Affairs Officer to join our team based in Malaysia. The role is a full-time, permanent position and is responsible for supporting our regulatory strategy, determining applicable regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide.

YOUR MISSION

Your main responsibilities will include:

  • Prepare and compile regulatory documentation, coordinate and execute regulatory submission with:
  • Middle East Region and respective countries
  • Asia Pacific Region and respective countries
  • Advise AliveDx staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
  • Develop product labelling regulatory requirements for AliveDx products and for customer contracted products including but not limited to package labels, product labels and instructions for use.
  • Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards.
  • Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs) Biologics License Applications (BLA), Medical Device Approvals (510(k), Canadian Medical Device Regulations (CMDR) – Part 1 and other non-registered product requirements to support compliance for AliveDx and its products.
  • Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialized information.
  • Contribute to the design and implementation of regulatory processes and identify areas for potential improvement.
  • Providing support, guidance and training as needed to fellow team members to ensure maintenance of world class regulatory team.

YOUR COMPETENCIES

  • A relevant degree and/or relevant work experience in a regulatory affairs environment.
  • Ability to prepare coherent regulatory reports and filings.
  • Effective communication with internal teams and external staff from regulatory bodies, customers, distributors and labelling and packaging suppliers.
  • Ability to work unsupervised and deliver end results under pressure and tight timelines.
  • Great attention to detail with a thorough and methodical approach to work. Ability to analyze information in a structured manner.
  • Generation and implementation of novel approaches to improvement of the business.

Interested? We look forward to receiving your application.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.

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