Feb 07, 2018

Regulatory Affairs Specialist at GE

  • GE Ethiopia
  • Addis Ababa, Ethiopia
Full time Healthcare Jobs in Ethiopia NGO Jobs/Nonprofit/Social Services Jobs in Ethiopia

Job Description

GE Job Vacancy in Ethiopia


About Us:

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

Role Summary:

The Regulatory Affairs Specialist – Region may be involved in Pre or Postmarket duties or both. They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket and postmarket support. He/she ensures accurate and optimal submissions of regulatory reports that meet the requirements of the region or country

Essential Responsibilities:

  • File and maintain regulatory deliverables
  • Analyze and communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies
  • Support regulatory inspections as required
  • Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and postmarket reporting through the development, maintenance and improvement of documented processes
  • Liaise with distributors on regulatory requirements
  • Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions
  • Communicate with Product RA to establish regulatory requirements, including clinical trial data
  • Complete specific country testing and work with Product RA; arrange for test devices and support as needed
  • Provide RA oversight to clinical studies to ensure regulatory requirements are met
  • Partner with Product RA to review advertising and promotion materials for country or regional compliance and approve these as required
  • Act as liaison with external regulatory reviewers to gain rapid approval of submissions
  • Work with Product RA for countries with license expiration requirements; establish plan and deliverables for timely submission for renewal of license Postmarket
  • Monitor external information for incidents or issues that may involve GEHC products; communicate information internally in a timely manner
  • Liaise with relevant personnel to ensure appropriate, timely input is provided for postmarket reports
  • Review field action information to determine if reportable in local country
  • Liaise with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports

Quality Specific Goals:

  • Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
  • Complete all planned Quality & Compliance training within the defined deadlines
  • Identify and report any quality or compliance concerns and take immediate corrective action as required
  • Ensure assigned regulatory submissions are accurate, complete and timely
  • Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility


  • Bachelor’s Degree (or internationally recognized equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 4 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations
  • Strong analytical skills
  • Ability to work in a team environment with minimal supervision on projects and activities
  • Ability to prioritize, plan & evaluate deliverables
  • Knowledge & experience conducting scientific, regulatory, legal, or business research.
  • Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
  • Experience using spreadsheet and presentation software
  • Must be willing to travel up to 5% of the time
  • Must have valid authorization to work full-time without any restriction in the role’s location

Desired Characteristics:

  • Advanced degree in scientific, technology or legal disciplines
  • Regulatory Affairs Certification (RAPS)
  • Experience in a medical device or pharmaceutical industry
  • Knowledge of Quality Management Systems (QMS)
  • Experience working across cultures/countries/sites
  • Demonstrated experience interfacing with regulatory agencies (e.g. FHMACA, ERPA, FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL
  • Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment
  • Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies

Locations: Ethiopia; Addis Ababa

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Apply Now