Regulatory Affairs Specialist, MEA, LivaNova, Dubai, UAE

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Join us today and make a difference in people's lives!

As a Regulatory Affairs Specialist you will perform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compile all materials required in submissions, license renewal and annual registrations. Recommend changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor and improves tracking/control systems. Keep abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommend strategies for earliest possible approvals of clinical trials applications.

Essential job functions :

Lead and manage submissions, approvals, licence maintenance to commercialize the Medical Devices manufactured and distributed by the Company in the International area with primary focus on CP equipment.

Lead and manage submissions, approvals, licence maintenance to commercialize the Medical Devices manufactured and distributed by the Company in the MECA region in compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections

Cooperate in the relationships with Vigilance Authorities, Competent Authorities and the National Government Agencies

Coordinate with RA at manufacturing sites for the preparation and editing of the technical and formal documentation necessary to get registrations, and keep them in compliance with product changes and local regulations.

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 on Company products

Provide regulatory expertise on relevant laws and regulations of MECA region affecting on Company products, and support the Sr. RA Manager Regulatory Affairs INTL to coordinate implementation plans to manage the regulatory actions due to MDR impact in International

Knowledge, skills and abilities required :

Good Knowledge of the relevant laws and directives for placing on the market and commercialize Medical Device

Good ability and experience in collection and preparation of technical and formal documentation necessary for submissions to Competent Authorities.
Good in preparation of organizational procedures.
Good attutude to interpersonal relationship, to efficient communication, written and oral; attitude to project management.
Good English and, possibly, another main Arabic language
knowledge of main tools of Office Automation

Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on

https://www.livanova.com/en-us/careers

, and check that all recruitment emails come from an @livanova.com email address.

DETAILS TO REGISTER FOR THIS JOB:
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https://livanova.wd5.myworkdayjobs.com/en-US/Search/job/Dubai-United-Arab-Emirates/Regulatory-Affairs-Specialist--MEA_JR-12077-1


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