Reporting to: Regulatory Affairs Manager
Q Medical Devices provide a full range of products and services to help OEMs bring medical devices to market. Specializing in silicone and other elastomerics, we manufacture a broad array of high-performance single-use devices as well as precision components and subassemblies. Our end-to-end services include engineering & development, regulatory affairs, quality assurance, and supply chain support. Our global team partners with OEMs to provide tailored solutions to meet your needs.
RA Specialist is responsible for supporting and executing the company regulatory & compliance strategy. The RA Specialist will support day to day regulatory operations including preparing regulatory submissions and reviewing critical documents to determine applicability and acceptability for regulatory submission. In addition, the RA Specialist will assist the organization in ensuring regulatory compliance to established standards/guidance and implementing procedures to ensure that the business unit’s regulatory program is effective and efficient. The RA Specialist will work jointly with the project teams and key stakeholders to ensure compliance and regulatory goals are met while also achieving excellence. This position will work closely with other functional areas, such as Quality, Engineering, Operations, and Marketing to assure alignment to commercial regulatory requirements of company products and customer requirements.
1. Preparing and maintaining regulatory documentation to maintain technical documentation including submission to applicable authorities
2. Preparation of clinical documentation, and responsibility to gather clinical documentation
3. Participate in risk management activities and perform benefit-risk assessments
4. Supply technical and regulatory documentation to support customer’s regulation process
5. Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires
6. Prepare and Asist with change notifications and submissions to NB and FDA
7. Project management for RA projects
8. Responsibility for vigilance raised from customer complaints to the various markets
9. Supporting PMS process by establish and provide applicable regulatory documents
10. Provide documentation and other support needed to assess and approve ECOs
Minimum qualification required:
Education: BA of Science and Technology (Chemistry, Biology, etc.)
2-3 years of Regulatory experience / CRA or clinical experience in the field of medical device industry.
Excellent /Good English
A diligent, organized, understanding and oriented character
- Excellent interpersonal skills and demonstrated ability to work as a team member in a global environment
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