Regulatory Affairs Specialist I

Masimo

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.