Regulatroy Affairs Specialist

The Opportunity

This position works out of our Kenyan Offices in the Rapid Diagnostics division. In this division our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe.

As the  Regulatory Affairs Specialist – EAST AFRICA , you will be responsible for obtaining and maintaining regulatory approvals and in meeting of in country regulations for IVD’s so to ensure Abbott products are compliant to meet appropriate in country regulations for all business units under Abbott Rapid Diagnostics for the region assigned.

What You’ll Do

Product registrations

Supports the preparation and timely completion of submission of registrations for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs for ARDX division for different business units - ID, CM and Tox for the assigned region.

Participation on cross functional project teams to provide the required input that enables strategic guidance to meet regulatory requirements for new product introductions pertaining to the region.

Works closely with commercial in aligning with required registrations or finding alternate pathways with authorities for products when under registration.

Perform impact regulatory assessments for new product introductions for the responsible countries and assist in the development of registration plans.

 Provides impact regulatory assessment arising from changes in product, manufacturing processes, labelling affecting IVD products in the distributed countries under responsibility, including communication to legal manufacturer Regulatory and project teams for impact assessment.

Provides visibility of ongoing product registrations and its status to through developed tracking processes monthly.

Follows up with regulatory authorities and Distributors on registration submissions until registered.

Updates the Regulatory Database (Velocity) with all product registration updates that assures status of currency.

Regulatory intelligence :

Communicates and clarifies (where required) registration requirements for input to RIGOUR and to Legal Manufacturers for implementation where required.

Update the Survey Database through regulatory intelligence gathered via Industry committees and Distributors and Authorities alike.

Promotes awareness of regulatory and customer requirements throughout the organisation through organised training programmes as and when required.

Participate in the country industry associations to keep abreast of changes in regulations and guidelines.

Reporting

Assess product complaints / Field actions for reportability for the countries under responsibility and support in the submission thereof.

Ensure PMS reporting for countries is collated by the LM and submitted within the timeframes stipulated by regulations in the countries under responsibility.

Support:

Support in the overseeing of regulatory conformance is ascertained for any localisation activities where applicable.

Support the Regulatory Director and Security team on reported cases of fraudulent / parallel imports in the countries under responsibility and assist in the reporting to the different authorities in country when required.

Support in providing clarity to the Legal manufacturer and RDIL Quality on product inclusions when required. 

Responsible for implementing and maintaining the effectiveness of the Abbott Quality System, when it applies to Regulatory compliance of procedures are upheld.

Required Qualifications

Bachelor’s degree (or higher) in a Healthcare or Life sciences’ discipline,

Preferred Experience

2 years of experience as a regulatory expert within Medical devices or Diagnostics is Essential Experience with Multiple countries, ideally Tanzania is essential Able to compile dossiers adapted to meet country regulatory requirements. Must have deep knowledge and successful track record with dealing with regulations / regulators in the regions assigned. Able to work through complex regulatory pathways in finding compliant solutions or application from available alternatives. Excellent communication skills (written and oral) Strong organizational and planning capabilities High analytical skills Strong attention to detail. Able to prioritize workload and meet stringent deadlines. Able to represent the company with professionalism and confidence. Able to travel (up to 15% of the time, or as circumstances dictate)