Job Details
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Job Description
- Prepare, Secure and update Medical device files
- Oversee vigilance and failed safety corrective action procedures
- studying scientific and legal documents
- Ensuring compliance with regulations set by competent authorities
- Offering advice about company policies, practices and systems
- Outlining requirements for labeling, storage and packaging
Others:
- To carry out any tasks given to him by the top management to achieve the objectives and any orientations in favor of the work
Job Requirements
Academic Level: Bachelors of Science or Pharmacy.
Experiences/Competency:
- A Bachelor’s degree in a relevant subject or suitable experience in a Regulatory affairs role
- Excellent knowledge of ISO 13485, CE and FDA requirements, with experience supporting regulatory submissions.
- Proven track record of regulatory submissions of technical files.
- Proven track record of preparing for and managing successful Quality audits and inspections
- Self-motivated and “can do” attitude, a willing to be flexible, with an ability to adapt to change
- An effective communicator
Skills:
Planning and Organizing
The job holder is required to plan and organize their own work and their team to achieve objectives.
Numeric ability
This job requires the ability to produce and analyze information, presented numerically.
Innovation
The jobholder is required to show a willingness to question traditional methodology and make recommendations on new ways of approaching problems and improving existing processes.
