Regulatory Affairs Specialist, MEA

Job Title: Regulatory Affairs Specialist, MEA

Join our team and make a difference in people's lives as a Regulatory Affairs Specialist. In this role, you will be responsible for coordinating and preparing document packages for regulatory submissions for new and mature products. Your primary focus will be to ensure alignment and compliance with local and regional registration requirements, as well as with company policies, internal audits, and inspections. Here are some of the essential job functions:

1. Submissions Management: Lead and manage submissions, approvals, and license maintenance for the commercialization of medical devices in the International area, with a primary focus on CP equipment. Ensure compliance with relevant laws and directives for placing products on the market.

2. Regulatory Compliance: Cooperate with Vigilance Authorities, Competent Authorities, and National Government Agencies. Coordinate with Regulatory Affairs teams at manufacturing sites to prepare and edit technical and formal documentation necessary for registrations, ensuring compliance with product changes and local regulations.

3. Documentation Review: Monitor, verify, and review product documentation (Instructions for use, brochures, etc.) to ensure compliance with relevant local law requirements. Provide regulatory expertise on relevant international laws and regulations impacting company products.

4. Expertise and Communication: Provide regulatory expertise on laws and regulations affecting Company products in the MECA region. Support the coordination of implementation plans to manage regulatory actions due to MDR impact in International.

Required Skills and Qualifications:

- Good knowledge of relevant laws and directives for placing medical devices on the market.
- Experience in collecting and preparing technical and formal documentation for submissions to Competent Authorities.
- Ability to prepare organizational procedures and manage projects efficiently.
- Excellent interpersonal and communication skills, both written and oral.
- Proficiency in English and, preferably, another main Arabic language.
- Familiarity with Office Automation tools.

Diversity & Inclusion Commitment:

At LivaNova, we value equality and celebrate diversity. Our recruitment process is fair, transparent, and free from discrimination. We are committed to ensuring that all candidates are assessed based on their qualifications and suitability for the role, without bias or discrimination.

Notice to Third-Party Agencies:

We do not accept unsolicited resumes from recruiters or employment agencies. Without a signed Recruitment Services Agreement, we will not consider or agree to payment of any referral compensation or recruiter fee. We reserve the right to pursue and hire candidates submitted without any financial obligation to the recruiter or agency.