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Job Description
- Generate, modify, update and maintenance of Technical documentation of devices in compliance with guidelines.
- Coordination with different departments to make sure that all sections of technical documentation are properly issued in accordance with applicable standards and make sure that they will satisfy the certification body.
- Ensure that each department applies the correct international standard for testing, validation, issuing document…etc. and instruct the proper route according to regulations.
- Annual update for TFs related to (CE, FDA and Canadian) according to an annual plan.
- Keep up to date with any new regulations and guidelines and apply any mandatory changes.
- Frequent follow up on applicable standards and update internal documentation accordingly and purchase any new harmonized standard on different departments. And make sure that any new standard is applied by the concerned department.
- Technical documentation related procedure regular review and update according to internal review frequency or according to updates in guidelines.
- Responsible for regulatory compliance according to international requirements and guidelines.
- Responsible for vigilance assessment report for each complaint based on information provided from the quality department and implementing the vigilance process in case of any reported case.
- Coordination with different departments for implementation of any vigilance or recall if any. And perform mock recall annually in case of no recalls during the year.
Job Requirements
- Scientific bachelor degree (Science, Pharmacy or related field)
- At least 1-3 years of experience as a regulatory affairs specialist in the medical device field.
- Full awareness of ALL new regulations European, American, Canadian, and any other related to the medical device industry. Special focus on MDR and FDA.
- Fluent English language. Other languages will be an asset.
- Excellent Computer skills (Word, Excel & PowerPoint).
- Attention to detail
- Ability to work under pressure
