Regulatory Affairs Specialist Medical Devices Jobs in Egypt and Careers in Silver Med Vacancies in Cairo 2013
Employer Silver Med
Job Title Regulatory Affairs Specialist Medical Devices
Languages Excellent in English
Country Egypt
Job Category Pharmacy, Science
Job Type Full Time
Description Registration Specialist Medical Devices. — Execute country registration process; prepare national registration dossiers & ensure timely submission. — Implementing the registration programs and registration procedure. — Preparing and delivering the needed samples for registration programs to the official research institutes — Follow up registration trails. — Collecting results and information from applies trials for registration. — Contact to registration authorities. — Ensure product standards guideline are implemented in projects and products — Timely submission, renewal and follow up of the registration dossiers to the authorities. — Free payments for registrations and sample analysis. — Shelf life extension of products (submission, sample analysis, analytical standards, fees) — .providing liaison guidance and assistance to the registration function. — Assisting in GMP standards, and ministry of health guidelines on registration. — Supporting GMP roles and functions of different ingredients in medical devices.
Qualifications Fluent English and Computer. Qualification: Chemistry degree. 3-5 years of experience in product registration. Liaison / Quality background is a plus. Understanding technical regulatory requirements and processes. Ability to manage multiple projects and demands at a time. Strive for achievement. Conflict management. Personal competencies: business knowledge. Quality orientation. Analytical ability. Process orientation. Planning skills. Adaptability and flexibility. Execution focus and result orientation. Energy and drive. Leadership ability. Communication. Assertiveness.
Gender Any
Experience 3 - 5 Years.
Other Skills Excellent in Computer and Internet.
Salary (L.E.) Negotiable
Job Contact Info. The job will ocated at El Obour City. If you are interested please send your CV with a recent photo to: eng.lashin@siver-med.com You must write the job title in the subject field, otherwise it will be automatically ignored.
Company Name Silver Med
Website www.silver-med.com
No. of Employees More than 100
Sector Health / Medical
Profile Based on its wide-ranging manufacturing repertoire, SILVER MED is able to provide further processing of tubes and moulded parts using all the standard production technologies. The product range extends from granules through tube sets and catheters right up to sterile and certified medical products. The use of the latest machinery and equipment in conjunction with on-time and target-orientated development work is the foundation for qualitatively high-value production. The specific requirements of the customer as well as the specifications of the relevant standards and official directives are also considered. Based on various manufacturing steps and work steps, SILVER MED offers options for the manufacture of medical modules up to and including sterile-packed and ready-for-use medical products, A widely diversified manufacturing repertoire can be offered: Manufacturing in our clean rooms class 100,000 according to In-house design and development of our own molds. Complete injection and extrusion line Advanced catheter manufacturing technologies in terms of Tipping , drilling Tube welding, Coiling , insert molding , uv welding and shrinkage. Ethylene oxide sterilization Validation and revalidation actions relating to the ETO sterilization are carried out in accordance with the harmonized standard DIN EN ISO 11135 Advanced needle bonding and siliconization Facility Advanced coating procedures.
Employer Silver Med
Job Title Regulatory Affairs Specialist Medical Devices
Languages Excellent in English
Country Egypt
Job Category Pharmacy, Science
Job Type Full Time
Description Registration Specialist Medical Devices. — Execute country registration process; prepare national registration dossiers & ensure timely submission. — Implementing the registration programs and registration procedure. — Preparing and delivering the needed samples for registration programs to the official research institutes — Follow up registration trails. — Collecting results and information from applies trials for registration. — Contact to registration authorities. — Ensure product standards guideline are implemented in projects and products — Timely submission, renewal and follow up of the registration dossiers to the authorities. — Free payments for registrations and sample analysis. — Shelf life extension of products (submission, sample analysis, analytical standards, fees) — .providing liaison guidance and assistance to the registration function. — Assisting in GMP standards, and ministry of health guidelines on registration. — Supporting GMP roles and functions of different ingredients in medical devices.
Qualifications Fluent English and Computer. Qualification: Chemistry degree. 3-5 years of experience in product registration. Liaison / Quality background is a plus. Understanding technical regulatory requirements and processes. Ability to manage multiple projects and demands at a time. Strive for achievement. Conflict management. Personal competencies: business knowledge. Quality orientation. Analytical ability. Process orientation. Planning skills. Adaptability and flexibility. Execution focus and result orientation. Energy and drive. Leadership ability. Communication. Assertiveness.
Gender Any
Experience 3 - 5 Years.
Other Skills Excellent in Computer and Internet.
Salary (L.E.) Negotiable
Job Contact Info. The job will ocated at El Obour City. If you are interested please send your CV with a recent photo to: eng.lashin@siver-med.com You must write the job title in the subject field, otherwise it will be automatically ignored.
Company Name Silver Med
Website www.silver-med.com
No. of Employees More than 100
Sector Health / Medical
Profile Based on its wide-ranging manufacturing repertoire, SILVER MED is able to provide further processing of tubes and moulded parts using all the standard production technologies. The product range extends from granules through tube sets and catheters right up to sterile and certified medical products. The use of the latest machinery and equipment in conjunction with on-time and target-orientated development work is the foundation for qualitatively high-value production. The specific requirements of the customer as well as the specifications of the relevant standards and official directives are also considered. Based on various manufacturing steps and work steps, SILVER MED offers options for the manufacture of medical modules up to and including sterile-packed and ready-for-use medical products, A widely diversified manufacturing repertoire can be offered: Manufacturing in our clean rooms class 100,000 according to In-house design and development of our own molds. Complete injection and extrusion line Advanced catheter manufacturing technologies in terms of Tipping , drilling Tube welding, Coiling , insert molding , uv welding and shrinkage. Ethylene oxide sterilization Validation and revalidation actions relating to the ETO sterilization are carried out in accordance with the harmonized standard DIN EN ISO 11135 Advanced needle bonding and siliconization Facility Advanced coating procedures.
