Retina Pharmaceuticals is a reputable and dynamic company that represents globally recognized suppliers and specializes in trading high-quality diagnostics, life sciences solutions, ophthalmic products, water treatment solutions, and related products and services. Our business scope supports major fields of scientific and medical endeavors that are essential to the progress of our society and the betterment of mankind. Our personal motivation is to offer our customers the best quality solutions.

Job Summary:

We are seeking a highly experienced Regulatory Affairs Expert with extensive knowledge of medical product registration, dossier evaluation, single window systems, MDR-EU 2017/745, and food and medicine device regulations under EFDA. The successful candidate will be responsible for ensuring compliance with national and international regulations, managing product registrations, and maintaining effective communication with regulatory bodies. This role requires strong attention to detail, excellent organizational skills, and the ability to work collaboratively with internal and external stakeholders.

Key Responsibilities:

• Manage the registration and renewal of pharmaceutical and medical device products in compliance with national and international regulations.

• Evaluate and prepare regulatory dossiers for product registration and submissions to regulatory authorities.

• Ensure timely processing of documentation required for importation and customs clearance.

• Advise on the requirements of new or existing regulations by the Ethiopian Food and Drug Administration (EFDA) and other relevant health bodies.

• Maintain organized and confidential records of all regulatory activities, including registrations, imports, and distribution.

• Facilitate and organize workshops and training sessions for staff to enhance knowledge of regulatory requirements, quality, and safety standards.

• Monitor the safety and quality of imported medical products throughout the supply chain, ensuring compliance during transportation and storage.

• Supervise the full cycle of imported products, including proper storage, utilization, and disposal according to EFDA guidelines.

• Maintain compliance with international standards (ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, and ISO 45001:2018) throughout all regulatory activities.

• Develop and implement strategies to improve regulatory operations and ensure compliance with national laws and regulations.

• Maintain strong relationships with suppliers and ensure all requirements for new product registrations are met.

• Regularly develop reports for the Deputy General Manager and ensure their approval.

• Adhere to the implementation of policies and procedures to ensure compliance with all quality, health, safety, environmental, and other regulatory requirements.

• Perform any other duties assigned by the Deputy General Manager.

Impact of Results:

• Ensure timely and accurate registration and renewal of pharmaceutical and medical device products.

• Maintain compliance with national and international regulatory standards.

• Enhance the organization’s regulatory operations and ensure the safety and quality of imported products.

Category: Health Care Export/ Import and Distribution
Location: Addis Ababa, Ethiopia
Salary: Negotiable
Number of Positions: One

Job Requirements

Required Skills and Experience:

• Education: BSc in Pharmacy or a related field from a recognized university.

• Experience: 5+ years of experience in regulatory affairs, with a focus on medical product registration, dossier evaluation, and compliance with MDR-EU 2017/745 and ERIS regulations.

• Experience in managing regulatory activities for imported medical devices and pharmaceuticals.

• Knowledge of single window systems, eRIS, and customs clearance processes.

• Strong understanding of food and medicine device regulations under EFDA.

Competencies:
The successful candidate will have:

• Strong interpersonal and communication skills.

• Excellent organizational and problem-solving abilities.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• A customer-focused approach with a sense of urgency for resolving issues.

• Ability to work independently and as part of a team.

How To Apply

Interested and qualified applicants can apply through job2@retina-pharma.com.