#WE ARE HIRING

REGULATORY TECHNICIAN

The role will be responsible for supporting the company’s global and regional regulatory affairs, ensuring compliance with international and local standards. equipment.

Requirements

• Prepare CE technical documentation and assist in collecting and organizing registration information.
• Complete FDA product listings (MDL) based on company’s US market needs.
• Maintain EU EUDAMED and US GUDID databases, ensuring timely import of product UDIs.
• Support customer and third-party audits with notified bodies.
• Communicate with PPB for GMP certificate updates, product registration, and free sale certificates.
• Maintain/apply for S-Mark certification with KEBS for locally sold products.
• Process UDI applications via GS1-Kenya accounts upon request from Engineering.
• Participate in temporary assignments and company emergency handling as directed by superiors.
• Collaborate with regulatory supervisors, engineering, QA, laboratories, manufacturing, and sterilization departments to ensure compliance.
• Maintain accurate records and relevant forms for all regulatory processes.

Qualifications

• At least 3 years proven work experience in regulatory affairs or compliance within manufacturing/pharmaceuticals.
• Strong organizational skills with attention to detail.
• Excellent communication and interpersonal skills.
• Ability to handle multiple tasks and prioritize effectively under deadlines.
• Bachelor's degree in Industrial Chemistry, Microbiology, or related field.

We are an equal opportunity employer

• Prepare CE technical documentation and assist in collecting and organizing registration information.
• Complete FDA product listings (MDL) based on company’s US market needs.
• Maintain EU EUDAMED and US GUDID databases, ensuring timely import of product UDIs.
• Support customer and third-party audits with notified bodies.
• Communicate with PPB for GMP certificate updates, product registration, and free sale certificates.
• Maintain/apply for S-Mark certification with KEBS for locally sold products.
• Process UDI applications via GS1-Kenya accounts upon request from Engineering.
• Participate in temporary assignments and company emergency handling as directed by superiors.
• Collaborate with regulatory supervisors, engineering, QA, laboratories, manufacturing, and sterilization departments to ensure compliance.
• Maintain accurate records and relevant forms for all regulatory processes.

• Strong organizational skills with attention to detail.
• Excellent communication and interpersonal skills.
• Ability to handle multiple tasks and prioritize effectively under deadlines.

• Bachelor's degree in Industrial Chemistry, Microbiology, or related field.