Officer/ Deputy Manager Regulatory Affairs - SAME

Regulatory Affairs Officer/ DM Regulatory Affairs - South Asia and Middle East

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.

The main purpose of the position:

Regulatory Affairs Associate – South Asia & Middle is responsible for ensuring that Regulatory Affair for Arjo are implemented, current, and monitored as required. Countries in the region include but are not limited to:

India, Sri- Lanka, Bangladesh, Bhutan, Nepal, Maldives, UAE, Saudi Arabia, Kuwait, Pakistan, Oman, QATAR, Bahrain, Jordan, Lebanon, and other markets.

This role works in collaboration with the Deputy Manager QRC South Asia, Director QRC & Projects, local SSU Teams and Distributers to:

• Ensure Regulatory Compliance for the Importation and Sale of medical devices in the Southern Asian and Middle Eastern Region.
• Liaise with local regulators
• Monitor regional regulations and ensure Arjo is compliant with changes
• define and implement QA strategies,
• implement continuous improvement of various processes
• identify and evaluate deficiencies, and minimize business risk

This role is key to ensuring products supplied in the assigned Region are registered, and are in compliance with the requirements of regulatory bodies and local law.

Main responsibilities:

Regulatory Compliance

• Liaison between the corporate international regulatory team, SA & ME SSU’s and regulators to support SSU and corporate compliance with applicable laws and regulations.
• Raise product clearance requests for new product licenses, license amendments and renewals as per Global SOP (Standard Operating Procedures).
• Review product registration dossiers from the corporate international regulatory team.
• Assist with ensuring all Arjo products supplied in the Region are registered with the applicable regulatory body using supplied product registration dossiers.
• Ensure Arjo products supplied in the Region are compliant with local or international standards where mandatory or required.
• Create processes within local 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.
• Prepare documentation for the purpose of registration with the regulatory bodies
• Obtain required documentation from the manufacturer to meet regulatory body audit requirements for Arjo products.
• Liaise with SSU Management teams to provide corporate international regulatory team with an annual report for product clearance planning activities for the next calendar year.
• Provide corporate international regulatory team updates to market regulatory requirements, relevant laws and regulations.
• 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.
• Provide monthly report on area activities to the Director QRC & Projects, and corporate international regulatory team.

Post Market Activities

• Document and process all Incident Reports with the relevant regulatory body ensuring the investigation, reporting, and finalization are dealt with appropriately and in line with regulatory, Arjo requirements.
• Liaise with the relevant Arjo Vigilance and Regulatory Bodies to create and issue field action documentation to the customers or facilities.
• Document and process all Incident Reports as instructed by Global Vigilance ensuring the investigation, reporting, and finalization are dealt with appropriately and in line with regulatory requirements.
• Conduct and/or assist/supervise local staff to conduct incident investigations
• Document and process all product recalls, TAN, SAN, FSN, and Stop Orders ensuring the investigation, reporting, and finalization are dealt with appropriately and in line with regulatory requirements.
• Ensure Field actions TAN, SAN, or FSN are coordinated and conducted in a timely manner, to the deadline and delays are minimized and reported.
• Ensure all required documentation is returned and supplied to the DCHU as required.
• Proactively engage in obtaining reimbursement for all fields’ action activities in line with Global SOP or local requirements.

TrackWise/ ERP

• Assist to ensure warranties, unplanned service, product incidents, Business Complaints, Non-conformances and CAPA are reported into Trackwise as instructed or required by Local or Global SOP
• Ensure that Trackwise KPI’s are met and monitored
• Liaise with Group DCHU to obtain any and all relevant documentation.

Quality Assurance

• Provide backup and support to Deputy Manager QRC in relation to design implementation, maintenance, and certification of Quality Management policies and procedures to meet the requirements of ISO AS/NZS 9001, 13485 and/or as Directed by Arjo management.
• Monitor publication of Global Management system SOP and associated documents.
• Assist with the compilation and presentation of Management Review reports to Senior Managers and Regional Management as specified in the quality system and/or as requested by the Management team.
• Assist with internal quality audits.
• Conduct supplier quality audits as required
• Conduct Distributor audits as required

General

• Discuss emerging or potential 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 compliance standards.
• Monitor projects to maximize 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.
• Keep the President, South Asia, Middle East and Director QRC & Projects, informed of all regulatory and vigilance issues that will have an effect on the business.

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