Regulatory Assistant (Medical Equipment)

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.