Regulatory and Tender officer

at Orbit Health Solutions plc
Location Addis Ababa, Ethiopia
Date Posted August 6, 2020
Category Engineering
Pharmacy
Job Type Full-time
Currency ETB

Description

 

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.

Job Requirements

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. 

 

Applying Instructions

interested applicant can send their CV and copy of diploma certificate to e-mail below;

dgm@orbiths.com

Phone number: +251 116 507 335

Address: TK building, 6th floor, office no. 601,602,603 at Commercial Bank of Ethiopia entrance side.

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