Regulatory Affairs Specialist I📣 Job Ad

About the Role

Masimo is seeking a motivated and detail-oriented Regulatory Affairs Specialist I to join our team in Riyadh, Saudi Arabia. This full-time position plays a crucial role in ensuring our products meet the regulatory requirements across the META (Middle East and Africa) region, facilitating global market access and supporting company operations. The ideal candidate will possess a strong understanding of international medical device regulations, particularly within the Middle East, and will be adept at managing complex documentation and liaising with various stakeholders.

Key Responsibilities

• Process and maintain international filings and registrations for assigned countries within the META Region.
• Generate and maintain product and process compliance checklists for the assigned countries.
• Stay up-to-date with 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 related to product and process regulatory requirements.
• Support operations, marketing, and sales teams by securing global market approvals necessary for product shipment.
• Prepare and maintain other regulatory documentation as needed for the assigned countries.
• Contribute to the implementation of regulatory best practices and efficient processes for regulatory information management.
• Generate or update quality system procedures owned by Regulatory Affairs as required.
• Participate in relevant projects as a regulatory subject matter expert.
• Collaborate with the Quality Assurance (QA) department to drive quality compliance within the region.
• Perform other duties or special projects as assigned.

Qualifications and Experience

• A BA/BS Degree, or an equivalent combination of education and experience, is required. Preferred degrees are in sciences, engineering, or biomedical engineering.
• A minimum of 3 years of experience in international medical device Regulatory Affairs.
• Demonstrated experience with current Middle East regulations.
• Experience working remotely with in-country representatives and with USA-based headquarters.
• Preferred experience includes 3-7 years of related work experience.
• Experience in patient monitoring systems, hospital-based equipment, software, or electronic devices is preferred.
• Good knowledge of META Region regulations on electro-medical devices and experience interacting with regulatory bodies are advantageous.
• Proficiency in document management systems, such as Oracle Agile PLM, and prior experience working within countries in the Middle East & Africa, as well as in international organizations, are considered a plus.

Required Skills and Attributes

• Excellent verbal and written communication skills in English.
• Excellent prioritizing, organizational, and interpersonal skills.
• Ability to work effectively in a fast-paced environment, managing multiple tasks and projects simultaneously.
• A detail-oriented individual with a "can-do" attitude, capable of working both independently with minimal supervision and collaboratively within a team environment.
• Willingness to accommodate a flexible working schedule across time zones, which may involve evening and weekend working hours depending on project requirements.

Work Environment and Details

This is a full-time position based in Riyadh, Saudi Arabia. The role requires adaptability to a flexible working schedule to accommodate project needs across different time zones. Collaboration with the Quality Assurance (QA) department is integral to driving quality compliance within the region.