Closing on: Nov 10, 2021
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.