Deputy Manager- Regulatory Affairs

4 weeks ago

india Antal International Full time
Job Description

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.

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