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Company Description
RegTrac is a healthcare regulatory partner specializing in Global Regulatory Affairs, Quality Systems, and Compliance for Medical Devices, Cosmetics, and Consumer Products. With expertise in navigating regulatory requirements across different markets, RegTrac helps MedTech companies innovate and expand globally while staying compliant. The company offers strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success.
Role Description
This is a full-time on-site role as a Regulatory Affairs Associate for Medical Devices located in Chennai. The Regulatory Affairs Associate will be responsible for handling regulatory documentation, ensuring regulatory compliance, interpreting and implementing regulatory requirements, preparing regulatory submissions, and managing regulatory affairs on a day-to-day basis.
Regulatory Affairs:
Regulatory experience in preparing technical files and supporting projects for CE/ UKCA in Europe.
In house EUMDR experience providing support for the clients and leading client projects.
Good knowledge of Medical device labelling and understanding of review & approvals for medical device labels.
Good knowledge of ISO standards / Industry compliance regulatory standards like ISO 13485/ 10993/ 14971.
Understanding of CER/CEP and provide support to clinical team.
Support & resolve regulatory document related queries from manufacturers and provide solutions.
Provide support for sales and solutioning in completing requirement analysis for leads in winning projects.
Ensure client projects are performed and documentation prepared, reviewed and approved in line with relevant legislation requirements and guidance, meeting any specific requests or methodologies following the system and procedures in place.
Manage and build on client relationships ensuring feedback sessions are completed on a regular basis.
Be up to date with changing regulatory requirements and guidelines and update the company with these changes.
Prepare solutions, proposals and estimate the required effort hours in support of sales team including supporting sales presentations.
Ability to manage projects and work cross-departmentally to gather project-specific requirements, information, and needs.
Foster a dynamic working relationship with RegTrac Clients.
RA-QMS:
Author review and approved relevant procedures as applicable as per the required QMS system.
Monitor Quality processes and procedures required to ensure the applicable standard is achieved, including approved QMS.
Provide internal stakeholders a guidance and recommendations in the application of all relevant Industry Standards and Regulations.
Monitor customer/supplier quality and provide rapid response for quality problems from regulatory requirements.
Provide support to oversee all Audits, external and internal inspections, and their reporting, ensuring compliance and conduct supplier/customer audits where required in collaboration with QA team.
Skills experience should include:
Relevant experience in Quality, Regulatory affairs or governance in a structured environment.
Have excellent written and oral communications skills to communicate clearly and effectively with third parties, regulatory authorities and management.
Inquisitive, self-motivated and focused.
Self-Starter, Keen to learn, Ability to plan, good organisational skills and work in a team.
Proven strengths in attention to detail, analytical ability, understanding and interpreting regulations.
Looking for a company where they may broaden their experience and grow with the company.
You will be process driven with a can-do approach to find fitting and effective solutions to move projects forward.
Educational Qualifications
Job ID: 106843815
