Regulatory and Tender officer 57 views

About us:- Orbit Health Solutions plc is a firm registered in Ethiopia and located  in Addis Ababa. The company is engaged in trading of diversified product lines of Medical

Job Brief:

The regulatory affair ensure that orbit Health solutions supplier’s products comply with the Ethiopian regulations and Keep up to date with national and international legislation and guidelines. This post requires a person with national and international bid /tender document preparing knowledge and experience.

 Responsibilities:

• Ensure that our supplier’s products comply with the regulations.
• Keep up to date with national and international legislation, guidelines and customer practices
• Collect, collate and evaluate dossiers for registration submission.
• Prepare submissions of license variations and renewals to strict deadlines
• Monitor and set timelines for license variations and renewal approvals
• Advise suppliers on regulatory requirements.
• Provide strategic advice to senior management throughout registration of a new product.
• Review company practices and provide advice on changes to systems
• Maintain good and regular contact with regulatory authorities.
• Negotiate with regulatory authorities for marketing authorization.
• Ensure Orbit Health Solutions PLC (OHS) licenses are adhered to.
• Check Tender websites, submit to managers with recommendations and decide the feasibility of the bid.
• Prepare and submit Tender document.
• Attained tender readings and report the result.
• Related job assigned by managers.

Experience

•  2-3 years’ experience in medical and pharmaceutical trading industries in regulatory position or organizing dozier, submitting to FMHACA for registration, follow it and get registration certificate.
• Tender document preparation experience

Qualification

• B.SC Degree from recognized University by Bio Medical Engineer, Pharmacy and related

Products Range knowledge May include:

• Medical Devices and Supplies
• Pharmaceuticals
• Veterinary medicines
• Complementary medicines
• Agrochemicals
• Pesticides
• Therapeutic devices
• Cosmetics.

Skills and Attributes:

• Ability to manage and prioritize a complex and varied workload
• Self- Sufficiency and problem solving skills
• Ability to respond positively to unexpected changes
• Ability to deal with people in a clear and diplomatic manner
• Ability to speak to a wide range of audiences on complex issues
• Networking Skills
• Ability to produce work product that is free of errors
• Ability to use technology as required.