Regulatory Affairs Specialist I (Medtech)

TL;DR

Regulatory Affairs Specialist I (Medtech): Managing international filings and product registrations across the META region with an accent on compliance checklists and regulatory requirements. Focus on liaising with in-country representatives, interpreting regional regulations, and driving quality compliance for medical devices.

Location: Riyadh, Saudi Arabia

Company

hirify.global is a global medical technology company specializing in noninvasive patient monitoring and hospital-based equipment.

What you will do

• Process and maintain international filings and registrations within the META Region.
• Generate and maintain product and process compliance checklists for assigned countries.
• Provide counsel, training, and interpretation of META Region regulatory requirements to company personnel.
• Liaise with in-country representatives on all matters relative to product regulatory requirements.
• Support operations, marketing, and sales with global market approvals for product shipment.
• Collaborate with QA to drive Quality compliance across the region.

Requirements

• Minimum 3 years of experience in international medical device Regulatory Affairs.
• Experience with current Middle East regulations.
• Excellent verbal and written communication skills in English.
• BA/BS Degree in sciences, engineering, or biomedical engineering.
• Willingness to accommodate a flexible working schedule across different time zones.
• Ability to work in a fast-paced environment with multiple concurrent projects.

Nice to have

• 3-7 years of related work experience.
• Experience in patient monitoring systems, hospital-based equipment, or electronic devices.
• Knowledge of META Region regulations specifically for electro-medical devices.
• Experience interacting directly with regulatory bodies.
• Proficiency in document management systems, such as Oracle Agile PLM.

Culture & Benefits

• Opportunity to work in a fast-paced, international organization.
• Collaborative team environment with high autonomy and minimal supervision.
• Engagement in global projects as a regulatory subject matter expert.