Regulatory Affairs Support at Stratostaff East Africa

Role Summary

• The Regulatory Affairs Support – 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 the Organization Health Care establishes and implements best practice processes and procedures in premarket and post market support.
• He/she ensures accurate and optimal submissions of regulatory reports that meet the requirements of the region or country

Qualifications

• 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
• 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
• Experience in a medical device or pharmaceutical industry
• 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

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 post market reporting through the development, maintenance and improvement of documented processes.

 Premarket

• 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 the organizations Health Care products; communicate information internally in a timely manner.
• Liaise with relevant personnel to ensure appropriate, timely input is provided for post market 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.

Competencies

• Advanced degree in scientific, technology or legal disciplines.
• 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 including PPB; TFDA, MHLW, Health Canada, etc. and standards bodies such as KEBS, TBS, AAMI, IEC, ISO, UL.
• PPB credentials for accessing PPB online portal.
• 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 the Organization Healthcare regulatory