Regulatory Affairs Specialist I
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Key skills for this role
About the Role
Masimo seeks a Regulatory Affairs Specialist I to manage international filings and registrations in the META Region. The role requires 3+ years of experience in international medical device Regulatory Affairs, knowledge of Middle East regulations, and excellent communication skills in English.
Key Skills for This Role
Responsibilities
- Process and maintain international filings/registrations in assigned countries within META Region
- Generate and maintain product and process compliance checklists for assigned countries
- Maintain up to date knowledge on applicable regulatory requirements in assigned countries
- Provide counsel, training, and interpretation of META Region regulatory requirements to company personnel
- Liaise with in country representatives on 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
- Contribute to implementation of regulatory best practices and efficient processes
- Generate/update quality system procedures owned by Regulatory Affairs
- Participate in relevant projects as regulatory subject matter expert
- Collaborate with QA to drive Quality compliance in the region
Requirements
- Minimum 3 years of experience in international medical device Regulatory Affairs
- Experience with current Middle East regulations
- Excellent verbal and written communication skills in English
- Experience working remotely with in country representatives and USA based headquarters
- Willingness to accommodate flexible working schedule across time zones
- Experience in patient monitoring systems or hospital based equipment preferred
Full Job Posting
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.
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