Looking for a candidate having experience in Regulatory affairs domain for one of the medical equipments manufacturng industry.

Roles and Responsibities:

Regulatory Compliance:

• Liaison as required between the corporate international regulatory team, SA & ME Region SSU’s and regulators to support SSU and corporate compliance with applicable laws and regulations.
• Define and implement RA strategies and minimizing business risk while operating within the ISO 9001 and 13485  standards, supporting product and company Regulatory requirements.
• Assist with ensuring all the products supplied in SA & ME Region are registered with the applicable regulatory body using supplied product registration dossiers.
• Ensure all the products supplied in SA & ME Region are compliant with local or international standards where mandatory or required.
• Create and maintain processes within the Quality systems to ensure new product is registered in a timely manner and cannot be supplied to customers without the correct legal requirements in place.
• Communicate any discrepancies, delays or requirements with the corporate international regulatory team in a timely manner.
• Obtain required documentation from the manufacturer to meet regulatory body audit requirements for company's products.
• Liaise with local sales teams, importers and distributors to ensure compliance with SOP’s regarding product registrations, import and marketing, providing training as appropriate.
• Maintain local records of distributors contacts, establishment licenses and associated product license
• Coordinate activities to support supplier audits of SSU and corporate facilities by regulators.

General Responsibilities :

• Discuss emerging or potential regulatory compliance issues with management or employees.
• Keep informed regarding pending industry changes, trends, and best practices and assess the potential impact of these changes on organizational processes.
• Design or implement improvements in communication, monitoring, or enforcement of regulatory compliance Standards.
• Monitor projects to maximise the probability for project objectives, success criteria, quality and time frames to be achieved.
• Manage project risk and apply appropriate actions to reduce risk.
• Maintain strong business relationships with existing customers by ensuring compliance with all contract requirements, obtaining feedback and maintaining quality work.
• Any projects or tasks as specified or requested by the Senior Director, Quality & Regulatory Compliance, Sales and Service, RoW.