Regulatory Affairs & Quality Assurance Manager (Ra/Qa)

On a global basis, Sysmex provides instruments, reagents and software in the in vitro diagnostics (IVD) domain. IVD is essential for diagnosing disease, determining treatment methods and monitoring treatment effects.
We have augmented our business to comprehensively cover activities ranging from research and development to manufacturing, sales and support services. We create new value through proprietary diagnostic technologies and aim to foster fulfilling and healthy societies for communities around the world.
Sysmex South Africa (SSA) seeks to employ a Regulatory Affairs & Quality Assurance Manager that will operate out of the SSA office based in Randburg, and will support SSA, East Africa unit & Sysmex West Africa affiliates.
This function will be primarily responsible for the integration and upkeep of the total Quality Management System including all Global & Local Corporate policies and procedures in accordance with (SAHPRA) and South African Medical Devices (SAMED) as well as other established international regulatory bodies in the various countries. The role will include ensuring company compliance with sound Quality Assurance and Regulatory Affairs principles related to all Sysmex medical instruments, associated reagents and related accessories in Africa including GMP, SOP’s, Distributor & Internal Audits, Training and Customer Complaints.
This role has the overall responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product lifecycle, to accelerate and ensure successful / device and other product registrations for both product launches and change management for marketed products. The role is also responsible for keeping abreast of any regulatory requirements or changes applicable to product commercialization within the target markets and communicating these requirements to the management teams including designing, implementing, and maintaining an effective quality system.
Collaboration with all functions for buy-in through communicating clear expectations & fostering commitment is essential for success in the role.
Your responsibilitiesRegulatory Affairs Responsibilties:
• Develop affiliates regulatory strategies and implementation plans for identified projects in development, new products and line extensions of commercialized products.
• Provide leadership and guidance through the interpretation of new and emerging local & international regulatory trends relevant to local business needs and develop and implement strategies and projects to optimize regulatory performance.
• Interpret and effectively deal with complex regulatory issues across the business in support of local and corporate goals.
• Act as a fully functional member of cross-functional teams and provide expertise on regulatory matters.
• Provide in-depth knowledge and experience in regulatory topics, quality management and the respective support for African business.
• Ensure that the Regulatory Information Management system is maintained and advise management team of potential regulatory risks – Proactively recommend compliant actions.
• Participate actively to represent Sysmex interests on global or regional regulatory platforms within relevant industry associations.
• Work on special projects that require high level regulatory leadership for the leadership team.
• Provide regulatory advice and perform regulatory assessments of business development opportunities.
• Maintain regulatory and all controlled documents in an access controlled environment.
• Responsible for regulatory review and approval of relevant product labeling, marketing and advertising documents.
• Responsible for scheduling and facilitation of regulatory compliance audits.
• Ensure strict adherence to the local regulatory guidelines as well as marketing code of practice (where applicable) and other relevant codes.
• Coordinate and responsible for completion of all relevant affiliates (SSA/EA/SCWA) product registrations and providing regulatory information required, supported by country teams.
• Manage interactions with SAHPRA and all other Regulatory authorities from the various countries in the relevant countries.
• Supports planning, preparation, and submission of new registrations & amendments as well as following up with SAHPRA and other regulatory authorities in relevant countries.
• Maintain product information databases. Also maintain registration and listing files including interim and monthly/annual reports as required.
• Support regulatory team (country registrations and review of registration documents), including WHO PQ/ERPD/FIND/GF.
• Establish and maintain system for Post Market Surveillance as required by WHO
Quality Assurance Responsibilities:
• Manage all the required ISO certification processes and provide oversight & guidance throughout the entire process & ensure success.
• ISO 13485 regulatory compliance - Support African affiliates in setting up the structures and processes: Compile, review, training and implementation of QMS.
• Manage the quality assurance team in the development / revision and implementation of standard operating procedures (SOPs) as required.
• Ensure compliance (GMP, GXP etc.) with appropriate SOP’s according to SAHPRA and all other regional / international guidelines.
• Liaise with SEG to share experience and best practices and to ensure alignment.
• Support and lead RA/QA team for internal quality compliance matters.
• Lead the RA/QA division activities to liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.
• Support and lead the compliance matters for QMS and SSA compliance / vigilance matters including COVID-19 compliance
• Is the designated COVID-19 compliance officer as per local COVID-19 regulations stipulated by South African NDOH. Is also the designated Protection of Personal Information Act (POPIA) compliance officer as per local requirements.
• Develop and deliver Quality Assurance and Regulatory related training programs.
• Manage the Internal Audit, CAPA program and Supplier CAPA program.
• Work with process owners of CAPAs and internal audit findings and ensure appropriate corrective actions plans are implemented and verified for effectiveness.
• Provide oversight to the on-going maintenance of the Quality System procedures; ensure that changes to the procedures are consistent with the intended purpose of the Quality System.
• Assess the effectiveness of the QMS through regular trending analysis of metrics, internal audits, corrective and preventive actions, customer feedback as appropriate.
• Ensure that company and quality system are compliant with all local guidelines and Sysmex / SEG specific regulations as they apply to medical devices commercialization.
• Supervise Quality agreements with our existing suppliers and potential new ones.
• Participate in instrument / product safety alert / recall SOP development and coordinates recalls.
• Participate in & guide the Quality System Audits by internal / external auditor.
• Maintain Sysmex medical device operations licenses for the assigned countries.
Budget Responsibility:
• Responsible for developing & managing overall regulatory affairs and quality assurance (RA&QA) function objectives for the responsible regions to support commercial activities
• Work in close association with all teams to accelerate delivery of local revenue targets.
• Manage RA&QA division budgets / expenses.
• Coordinate external RA/QA consulting resources where required.
• Ensures delivery within role and ensures team works within operating guidelines.
Strategy Development & Execution:
• Participate as an active member of the African and SSA Management Team and actively contributes in the development of overall business strategy & organizational growth.
• Provide strategic leadership and coordination of these key functions (regulatory affairs & quality assurance & compliance) to ensure that the short-term and long-term objectives of the company are met.
• Development of a RA/QA strategic plans in support of the annual business plan, ensuring alignment with the overall company strategy.
• Work in close partnership with SEG and all relevant African affiliates to build and cultivate a robust and growing pipeline of products or service offerings for the Africa region.
• Develop a system for the appropriate collation and handling of customer product complaints & relevant reporting matrices.
Authorized Representative (AR) Responsibilities:
• Shall be the registered AR for the organization and accountable to the relevant authorities in terms of all applicable regulations
• To ensure licensing of all Sysmex activities with SAHPRA, various Departments of Health and all other relevant licensing authorities in East & West Africa, and to ensure maintenance and upkeep of such licensing as per each country guidelines.
• To ensure the practice of the business under the auspices of the marketing code of conduct.
• Lead local compliance team in collaboration with Senior Management.
Your profileEducation:
• Science degree (BSC –Medical science /B-Pharm / Human Physiology with background of at least 5 years exposure in the IVD /Medical Devices industry specifically
• A post graduate / business related qualification would be an added advantage
Experience:
• At least 5 years’ medical devices / IVD / industry expertise and knowledge thereof,
• A minimum of 5 years RA/QA expertise.
• A minimum of 4-5 years’ line management experience
• Has experience in South Africa and Sub-Saharan Africa / other regulatory bodies registration processes and amendments / listing processes.
• Strong management and leadership skills along with strategic thinking ability, and a proven track record of regulatory & quality assurance successes.
• Self-driven with a high degree of initiative and sense of urgenc...