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:

BA/BS Degree, or equivalent combination of education and experience is required. Preferred degrees in sciences, engineering, or biomedical engineering.

Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position?

Please send your full application.

To learn more about us, please visit:  www.masimo.com