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About the job
Role Title Senior Regulatory Affairs & Quality Manager
Location Dubai
Type Permanent Role
At Smith+Nephew, we believe in our products. We believe that through innovation, development and supporting our customers and patients we can help others achieve a Life Unlimited!
An excellent opportunity has arisen for a Regulatory Affairs & Quality Manager MENA & SSA to be based in Dubai.
This role involves ensuring product registrations and market continuity as well ensuring regulatory compliance in MENA & SSA region.
The successful candidate will be responsible for the Regulatory Affairs & Commercial Quality activities in the UAE facilities/sites, relating to the commercial distribution of medical devices in MENA-SSA.
Sound Exciting? We believe so!
Responsibilities include:
Regulatory Affairs:
Product registrations and market continuity as well ensuring regulatory compliance in MENA & SSA markets
Support local/regional/global regulatory affairs projects as needed and expand knowledge in local regulatory affairs management.
Partner with stakeholders and document internal regulatory processes such license renewals and registrations.
Carry out a full cycle of registration of medical devices in MENA & SSA countries in accordance with the business needs of the company aligned with in-Country and MEA QRA Management.
Maintain familiarity with company product ranges supplied in MENA & SSA region.
Support local/regional/global regulatory affairs projects as needed and expand knowledge in local regulatory affairs management.
Ensure preparation and submission of registration dossiers for MENA & SSA for new product registrations, line extensions, variations and renewals as required.
Ensure preparation and submission of tender documents for MENA & SSA as required.
Develop and maintain standard operating procedures or local working practices.
Provide registration expertise to enable business growth in full compliance to policies, local laws, regulations..etc. Partner with stakeholders and document internal regulatory processes such license renewals and registrations.
Carry out a full cycle of registration of medical devices in MENA & SSA countries in accordance with the business needs of the company aligned with in-Country and MEA QRA Management
Maintain familiarity with company product ranges supplied in MENA & SSA region.
Ensure preparation and submission of registration dossiers for MENA & SSA for new product registrations, line extensions, variations and renewals as required.
Ensure preparation and submission of tender documents for MENA & SSA as required.
Develop and maintain standard operating procedures or local working practices.
Provide registration expertise to enable business growth in full compliance to policies, local laws, regulations..etc.
Represent and advocate S+N position at the SFDA & other MOH and the local trade associations.
Participation in the local Working groups` meetings, MOH meetings, RA seminars and conferences as per business needs and in alignment with the line manager.
Ensure to provide the related stakeholders with necessary information related to the field action (such as product traceability of medical devices).
Adverse event and FA reporting to the MOH inline with the local regulation and S+N standards.
Commercial Quality
Quality Management Representative for MENA & SSA, managing the Quality Management System (QMS) covering this region.
Responsible for development, implementation and maintenance of an adequate and effective Quality Management System for MENA & SSA commercial operation.
Ensure that necessary systems and procedures are in place to satisfy applicable regulations, quality standards (including but not limited to ISO 13485), customer requirements and audits.
Implement relevant QMS procedures and ensure compliance & Introduce new systems and procedures where appropriate.
Undertake internal audits, and external audits as necessary.
Work proactively with Directors, Managers, Supervisors and Employees, to maintain a programme of continual improvement within the areas of responsibility. Contribute to new business initiatives and projects and review and communicate the impact on Quality activities for the site.
Liaise with Global Functions as required and as per the Global Quality System.
Be on the lookout for opportunities for improvement and develop new efficient procedures.
Ensure compliance to cGDP, ISO 9001 (if applicable), ISO 13485 and any other applicable quality standards or regulations in the MENA & SSA region, concerning medical devices distributed/marketed by the site.
To comply with high standards of occupational Health & Safety in the workplace as per the company policy and procedures.
Manage field action process for MENA & SSA and ensure reconciliation of product returns as part of the field action.
Responsible for management of quality holds and complaints for MENA & SAA.
Responsible for maintaining and developing quality and compliance for commercial distribution operations across MENA & SSA e.g. loan, consignment and servicing activities.
Manage deviations, non-conformance report, corrective action requests, root cause analysis and change control actions.
Ensure Quality Management Reviews are held as per the agreed timetable.
Report against agreed quality metrics on a monthly basis.
Train employees and distributors in aspects of the quality system and application of relevant procedures.
Additional Responsibilities Include:
Relationship Management
Work collaboratively, negotiate, and engage with key stakeholders including the distributors to facilitate delivery and compliance of the Quality & Regulatory strategy within the region.
People Management
Contribute and support in setting department objectives/KPIs and review and assess ongoing performance of direct reports.
Ensures professional development of self and direct reports and personal knowledge of applicable parts of GDP, ISO 9001 (if applicable), ISO 13485 and any other applicable quality standards in the region or regulations concerning Medical Devices distributed/marketed by the site.
To proactively manage and develop the performance of direct reports through performance management, calibration, resource review and planning, capability, disciplinary, training and development to meet the needs of the business
Experience:
Minimum 5 yearsÂ’ experience in Regulatory Affairs and Quality Management activities related to medical devices.
Demonstrated ability to consistently achieve regulatory and quality requirements.
Experience in conducting audits and CAPA management.
