Officer/ Deputy Manager Regulatory Affairs - SAME

Officer/ Deputy Manager Regulatory Affairs - SAME

Date: May 17, 2024

Location: Mumbai, Off Veera Desai Road (, Mumbai, IN - India

Company: Arjo

Empowering careers at ARJO

At Arjo, we know what moves us. We go above and beyond for people facing mobility challenges. We take every opportunity to work and grow as one team and take pride in sharing our knowledge and experience. Does that sound like something that moves you too?

This could be your opportunity to begin a challenging and rewarding career in a healthcare company that empowers movement for people with mobility challenges.

Main purpose of the position:

The individual in this position is responsible for ensuring that the Regulatory affairs for the region of SAME are handled properly.

This role works in collaboration with the local SSU Teams to define and implement RA strategies and minimizing business risk while operating within the ISO 9001 and 13485 standards, supporting product and company Regulatory requirements.

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.
• Assist with ensuring all Arjo products supplied in SA & ME Region are registered with the applicable regulatory body using supplied product registration dossiers.
• Ensure Arjo 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 Arjo 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

• 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.

Internal and External Contacts/Relationships:

Main contacts, internal;

• President South Asia and Middle East
• Senior Director, Quality & Regulatory Compliance RoW
• Regional Management team members
• Global Regulatory Teams

Main contacts, external;

• Factories
• Major suppliers
• Customers
• Distributors

Special Features/Conditions:

• This role requires occasional international travel.
• The role requires occasional work after normal business hours.
• The role requires extensive international contact working within international time zones

About Arjo

At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.

For more information about Arjo visit www.arjo.com