Regulatory Affairs Specialist

1 week ago

Singapore CREDO DIAGNOSTICS BIOMEDICAL PTE. LTD. Full time

Participate in and contribute to regulatory strategy development and planning, including identifying regulatory risks and opportunities, and developing mitigation strategies.


  • Maintains approvals/licenses/authorizations for existing marketing authorizations.
  • Track regulatory milestones in the internal Regulatory database and report submission status to the management at the defined interval.
  • Establish and conduct postmarket surveillance.
  • Keeps abreast of regulatory procedures and changes, conducts impact assessments, and provides periodic updates to relevant departments in the organization.
  • Review and assess product/ process change impacts and craft regulatory notification plans.
  • Responds to customers' and/or authorities' requests/inquiries and resolves issues regarding regulations and compliance matters.
  • Assists in the review of product labeling/advertising materials for accuracy and regulations compliance.
  • Assists in the preparation of dossiers for use in international registration by the Business development team.
  • Provide regulatory guidance and support to crossfunctional teams, including R&D, quality, clinical, and manufacturing, on regulatory requirements and implications for product development.
  • Prepare and maintain regulatory documentation, such as regulatory strategies, technical files, and design dossiers, and ensure accuracy and completeness of documentation.
  • Ensure the registration database is updated and inform the relevant departments of any changes.
  • Work with Quality Assurance Team on complaints, NCRs, CAPAs, medical device reporting, and field actions.
  • Participate in the regulatory inspection by the regulatory authorities and certification bodies.

Requirements:

  • Bachelor's or master's degree or higher in Life Science/ Molecular Biology/ Biotechnology/ Biomedical Engineering, or equivalent combination of education and experience.
  • Strong written and oral communication, and technical writing skills in both English and Chinese
  • At least 3 years or more of direct experience in regulatory affairs function in a regulated environment (medical devices/pharmaceutical industry).
  • Technical knowledge and experience to work effectively with others in diverse areas of business (Operations, R&D, Business Development, Human Resources, Procurement, Finance), is preferred.
  • Strong in communication, presentation, documentation, and interpersonal skills, and a team player.
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

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