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.

Apply Here