Our client who is into "Medical Equipment" is looking for a skilled "Regulatory Assistant" to work in their Colombo office immediately.
SALARY: Negotiable
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.
QUALIFICATIONS & EXPERIENCES:
- 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.
HOW TO APPLY:
If you are interested, please forward your CV to, This email address is being protected from spambots. You need JavaScript enabled to view it.
(Please use the same vacancy name for your subject title for better visibility of your email.)
Colombo, Sri Lanka
