Regulatory Assistant (Medical Equipment)

Closing on: Nov 10, 2021


SALARY: Negotiable

Our client who is into “Medical Equipment” is looking for a skilled “Regulatory Assistant” to work in their Colombo office immediately.

Roles & Responsibilities

  • Perform all work in compliance with company policy and within the guidelines of our quality systems.
  • Aid more senior regulatory specialists with the following tasks:
    • Initiation, collection, and coordination of information of regulatory documents for various purposes.
    • Preparation and maintenance of product technical files for CE marking.
    • Organization and preparation of documents for international submissions.
    • Coordination with international counterparts to obtain product approvals and renewals.
    • Conduct research about new regulations and guidance documents.
    • Assessment of product change impacts (device/labeling) for local and international markets.
    • Development and review of corporate and department procedures.
    • Adverse event reporting and field actions.
  • Organize, update, and maintain regulatory documentation in accordance with department and company procedures.

Qualification and Experience

  • Age below 30 years.
  • G. C. E. A/L in BioScience or Commerce stream.
  • Experience in the regulatory field an added advantage.
  • Basic IT skills are a must. (Email, Internet, MS-Office, etc.)
  • Excellent interpersonal & communication skills.
  • Excellent command in both spoken & written English language.
  • Ability to follow confidentiality guidelines.
  • Ability to handle multiple tasks and priorities.
  • Ability to work independently with minimum supervision in a team environment.
  • Good organization, coordination & time management skills.
  • Good problem-solving & negotiation skills.
  • Living within close traveling distance to Colombo is preferred.

Company: Manpower Sri Lanka
Company email: [email protected]
Job Location: Colombo
Job Category: Hospital and Health care
Job Type: Full Time

Apply now

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