Regulatory Affairs Specialist At Amecath Egypt
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About the job
About the Company:
We are a leading manufacturer & provider of medical devices for catheters in the fields of urology, intravascular, and dialysis.
About the Role:
Regulatory Affairs Specialist (International Registration), Responsible for registration of Amecath products all over the world according to organization planned distribution network and list of distributor. Coordination between foreign customers/authority and different departments to ensure fulfilling all regulatory requirements of exporting country.
Responsibilities:
- Directly communicate with customer and/or health authority at importing country to get all information about required documents for product registration.
- Registration dossier preparation according to each authority requirements by active communication with distributor for accuracy.
- Make sure that registration dossier successfully submitted by distributor in order to start the registration process.
- Close follow up for products under registration and fulfil any additional requirements raised from authority during review process.
- Handling any issues related to export approvals with local health authority in coordination with logistics and local regulatory affairs manager.
- Direct communication and handling all documents from local authority required from foreign health authority to finalize registration procedure. This shall be in coordination with local regulatory affairs manager.
- Review Distribution Agreement/contracts from Regulatory point of view.
- Issue, review and approve all Letter of authorization for registration purposes and ensure they are aligned with business contracts.
- Review and approval of all products artwork (inner labels, outer labels, shelf cartoon and Instructions for Use (IFUs).
- Follow and ensure proper creation of Unique Device Identification (UDI) and make sure it’s available on all device documentation and packaging materials.
- Coordination for special labelling requirements between distributor and concerned departments at Amecath.
- Follow, generate and update the internal process of drafting and labelling “Artwork approval”.
- Generation and frequent updates of Regulatory Registration Procedures.
- Stay up to date with all new regulations and guidelines at least at countries in which we have our devices registered.
Qualifications:
- Scientific background (Science, Pharmacy or related field).
- Fluent English language. Other languages will be an asset.
- Academic training, Medical Devices guidelines. ISO 13485, European Medical Device Regulations (MDR), American Food and Drug Administration (FDA)…. etc.
Required Skills:
- At least 2-4 years of experience as regulatory affairs specialist.
- Experience in communications with health authorities. Local or internationally.
- Awareness of business partnership and contracting.
- Up to date with all international guidelines.
- Market/sales oriented.
Preferred Skills:
- Perfect communication skills especially business writing.
- Computer skills. Windows, office and internet.
- Negotiation and presentation skills.
- Decision making and problem handling.
- Multi-tasking and can manage many projects at the same time with proper results and high accuracy level.