Regulatory Affairs Specialist I

Duties & Responsibilities

• Process and maintain international filings/registrations in the assigned countries within the META Region.
• Generate and maintain product and process compliance checklists for the assigned countries.
• Maintain up-to-date knowledge on applicable regulatory requirements in the assigned countries.
• Provide counsel, training, and interpretation of applicable META Region regulatory requirements to company personnel.
• Liaise with in-country representatives on all matters relative to product and process regulatory requirements.
• Support operations, marketing, and sales with global market approvals for product shipment.
• Prepare and maintain other regulatory documentation, as needed in the assigned countries.
• Contribute to the implementation of regulatory best practices and efficient processes for regulatory information management.
• Generate/update quality system procedures owned by Regulatory Affairs, as required.
• Participate in relevant projects as regulatory subject matter expert.
• Perform other duties or special projects, as assigned.
• Collaborate with QA to drive Quality compliance in the region

Minimum Qualifications

• Minimum 3 years of experience in international medical device Regulatory Affairs.
• Experience with the current Middle East regulations
• Excellent verbal and written communication skills in English.
• Experience working remotely with in-country representatives and with USA-based headquarters.
• Excellent prioritizing, organizational and interpersonal skills.
• Willingness to accommodate a flexible working schedule across time zones that may involve evening and weekend working hours depending on project requirements.
• Ability to work in a fast-paced environment, with multiple tasks/projects.
• A detailed-oriented individual with a “can do” attitude and ability to work in a team environment as well as individually with minimal supervision.

Preferred Qualifications

• 3-7 years of related work experience.
• Experience in patient monitoring systems, hospital-based equipment, software or electronic devices.
• Good knowledge of the META Region regulations on electro-medical devices.
• Experience interacting with regulatory bodies.
• Proficient in document management systems, such as Oracle Agile PLM.
• Prior experience working within countries in Middle East & Africa.
• Prior experience working in international organizations.

Education