Regulatory Affairs Manager

1 day ago

Johannesburg, South Africa Abbott Laboratories Full time

**DO WORK THAT MATTERS.**

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

Abbott Rapid Diagnostics (ARDx) is a sub-division of Abbott Diagnostics, created from the acquisition of Alere.

**Job Purpose**:
The Regulatory Manager will be responsible to coordinate and manage the Regulatory activities for the IVDs portfolio in a selected set of countries in Africa and as well assist the RA regional lead with Regulatory Activities of the African Region

**RESPONSIBILITIES**:

- Assist with the Development of regulatory submission strategies in collaboration with manufacturing sites, supply chain, marketing, commercial affiliates and distributor countries to ensure successful registration and approval of products in selected countries
- Work closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal or amendment to existing product certificates in a timely manner.
- Review regulatory documents and files (including product label, promotional materials, manufacturing change requests, and registration packages), record product filings, approvals, and registration activities.
- Execute plans, complete tasks according to priorities, align work with business goals, and align actions with agreed strategies.
- Track regulatory milestones in required Regulatory tracker
- Monitor and anticipate changes in local regulations and inform relevant stakeholders in a timely manner. Conduct impact assessment and plan for execution plan accordingly.
- Establish strong connections with internal and external stakeholders
- Represents RA at relevant meetings.
- Ensure compliancy of Alere Nigeria entity with regards to all regulatory requirements.
- Manage any queries pertaining to regulatory requirements and post market surveillance / regulatory reporting requirements.
- Maintain up-to-date knowledge of regulations in Nigeria and other countries under responsibility and their applicable guidelines and monitor development of regulations for the regions.
- Review promotional material for regulatory applicability for Alere Nigeria and regulated countries under responsibility

**Regulatory Intelligence and Reporting**:
Communicate changes to regulation and its impact to the legal manufacturer and other internal stakeholders.

Support day-to-day activities and clarifications of the Regulatory Product inclusion process when required.

**Product Registrations**
- Support 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 - IDEM, CM add Tox for the region under responsibility
- Participation on cross functional project teams to provide input to the QARA Director that enables strategic guidance to meet regulatory requirements for new product introductions pertaining to specific to the regions.
- Verify that impact regulatory assessments for new product introductions conducted by RA support staff, for the responsible countries and assist in the development of registration plans
- Conduct Assessments and applicable documentation of changes in product, manufacturing processes, labeling affecting IVD products distributed in the countries under responsibility
- Work closely with commercial regional teams and leads and align on business requirements and objectives

**QUALIFICATIONS and Experience**:

- Bachelor’s/Master’s Degree in Engineering, Medical/Biomedical background or other science related field
- 6-8 years of experience in Regulatory Affairs in Medical Devices in Africa, ideally in IVDs in preferred
- Experience in working in a multi-function team environment

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