Overview
Regulatory Affairs Specialist Jobs in Riyadh, Saudi Arabia at Masimo
Position: 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 detail‑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
BA/BS Degree, or equivalent combination of education and experience is required. Preferred degrees in sciences, engineering, or biomedical engineering.
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Title: Regulatory Affairs Specialist
Company: Masimo
Location: Riyadh, Saudi Arabia
Category: