|Location||Addis Ababa, Ethiopia|
|Date Posted||August 6, 2020|
|Category|| Engineering |
|Job Type|| Full-time |
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
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.
- 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.
- 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
- B.SC Degree from recognized University by Bio Medical Engineer, Pharmacy and related
Products Range knowledge May include:
- Medical Devices and Supplies
- Veterinary medicines
- Complementary medicines
- Therapeutic devices
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.
interested applicant can send their CV and copy of diploma certificate to e-mail below;
Phone number: +251 116 507 335
Address: TK building, 6th floor, office no. 601,602,603 at Commercial Bank of Ethiopia entrance side.