Company Overview RegTrac is a leading 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 diverse markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success. Role description We are seeking a proactive and results-oriented Business Development Associate to join our team. The Business Development Associate will support the growth and expansion of RegTrac's client base by identifying new business opportunities, fostering client relationships, and promoting our regulatory affairs services. This role is ideal for someone with a passion for business development and a keen interest in the regulatory affairs sector. Key Responsibilities Market Research and Analysis : Conduct market research to identify potential clients and business opportunities in the healthcare and medical technology sectors. Analyze industry trends, competitor activities, and market demands. Lead Generation : Identify and qualify new business leads through various channels, including online research, networking events, and industry conferences. Maintain a pipeline of prospective clients. Client Outreach : Initiate contact with potential clients via email, phone, and in-person meetings. Present RegTrac’s services and value propositions to prospective clients. Proposal Development : Assist in the preparation of proposals, presentations, and marketing materials. Tailor proposals to meet the specific needs and requirements of potential clients. Relationship Management : Build and maintain strong relationships with existing and prospective clients. Understand client needs and provide solutions that align with their regulatory compliance goals. Sales Support : Support the business development team in developing and implementing sales strategies. Track and report on sales activities, pipeline status, and progress towards targets. Collaboration : Work closely with the regulatory affairs team to understand service offerings and client requirements. Collaborate on the development of new services and market strategies. Event Participation : Represent RegTrac at industry events, conferences, and trade shows. Network with industry professionals and promote our services to a wider audience. Required Qualifications : Education : Master’s degree in business, marketing, life sciences, or a related field. Experience : 0-3 years of experience in business development, sales, or a related field, preferably within the healthcare, regulatory affairs or consulting sectors. Internship experience in business development will also be considered. Skills : Excellent communication, negotiation, and interpersonal skills. Strong organizational and time management abilities. Proficiency in Microsoft Office Suite and CRM software. Attributes : Highly motivated, results-driven, and able to work independently as well as part of a team. Strong analytical and problem-solving skills. Ability to manage multiple tasks and meet deadlines. · Knowledge : Basic understanding of regulatory affairs and compliance requirements in the healthcare sector is a plus. Familiarity with CRM systems and sales tools. Why Join RegTrac? Work with a global leader in regulatory affairs, supporting cutting-edge medical technologies. Collaborate with cross-functional teams in a dynamic and supportive work environment. Opportunities for professional growth and development. Show more Show less
Company Overview RegTrac is a leading 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 diverse markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success. Role Description: We are seeking a highly motivated Senior Regulatory Affairs Associate who will lead and support regulatory projects across global markets, with a focus on Clinical Documentation – Clinical Evaluation & Investigations for CE/UKCA, EU MDR compliance, and medical device documentation. In this role, you will be managing client relationships, preparing regulatory submissions, and ensuring adherence to ISO and QMS standards. You will collaborate cross-functionally, support audits, and contribute to solution development for new business. Ideal for a proactive, detail-oriented professional seeking to grow in a dynamic regulatory consulting environment. Key Responsibilities: Regulatory Affairs: · Regulatory experience in preparing CER/CEP, technical files and supporting projects for CE/ UKCA in Europe. · 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. · 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 relationship’s 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, teams 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. Qualifications: · Advanced degree (Master’s or PhD) in a relevant field. · 5 years of 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. Why Join RegTrac? At RegTrac , you'll join a collaborative, supportive team that values expertise, curiosity, and purpose. The company fosters a culture of continuous learning, where your voice matters and your growth is actively supported through mentorship, diverse global projects, and real responsibility. You’ll be part of a close-knit community passionate about regulatory science and improving healthcare outcomes, with the flexibility to work remotely and balance life outside of work. At RegTrac, it’s not just about compliance—it’s about making a meaningful impact together, in a place where people genuinely enjoy what they do and who they do it with.
Regulatory Affairs Associate – Cosmetics Company Overview RegTrac is a leading 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 diverse markets, RegTrac empowers companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success. Role Description We are seeking a highly skilled and experienced Toxicologist specializing in Cosmetics to join our dynamic team at RegTrac. In this pivotal role, you will leverage your expertise in cosmetic product safety to guide the development of compliant, high-quality formulations. You will be responsible for ensuring that all cosmetic products meet regulatory requirements and safety standards while contributing to innovative research and product development initiatives. Key Responsibilities Conduct toxicological safety assessments for cosmetic products in compliance with EU Regulation 1223/2009, US MoCRA, CDSCO regulations, and other international frameworks. Review and evaluate qualitative and quantitative formulations and supporting raw material documentation. Analyze data from stability studies, microbial testing, preservative efficacy (challenge) tests, SPF evaluations, and other cosmetic safety studies. Prepare and author Cosmetic Product Safety Reports (CPSRs), Product Information Files (PIFs), and other toxicology-related cosmetic documentation. Interpret toxicological profiles of cosmetic ingredients and identify potential risks or safety concerns. Provide expert input on safety thresholds, exposure assessments, and formulation recommendations for cosmetics. Stay updated with current cosmetic toxicology research, regulatory changes, and ingredient safety guidelines across EU, US, and Indian (CDSCO) markets. Collaborate with cross-functional teams (R&D, QA, Regulatory Affairs) to integrate toxicological insights into product development. Qualifications A university degree or higher qualification in toxicology, pharmacy, medicine, biochemistry, or a related discipline, in accordance with EU Regulation 1223/2009, MoCRA, and CDSCO requirements. In-depth knowledge of toxicological testing methods, cosmetic ingredient safety, and regulatory frameworks (EU, US, CDSCO, and international equivalents). 2+ years of experience in cosmetic regulatory toxicology. Proven experience in preparing CPSRs and PIFs for cosmetic products. Strong analytical and problem-solving skills, with the ability to interpret complex toxicology data and communicate findings effectively. Excellent written and oral communication skills to interact with third parties, regulatory authorities, and internal teams. Self-motivated, detail-oriented, and driven by curiosity. Why Join RegTrac? At RegTrac, you'll join a collaborative, supportive team that values expertise, curiosity, and purpose. We foster a culture of continuous learning, where your voice matters and your growth is actively supported through mentorship, diverse global cosmetic regulatory projects, and real responsibility. You’ll be part of a close-knit community passionate about cosmetics regulatory science and product safety, with the flexibility to work remotely and balance life outside of work. At RegTrac, it’s not just about compliance—it’s about making a meaningful impact together, in a place where people genuinely enjoy what they do and who they do it with.
Company Overview RegTrac is a leading 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 diverse markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success. Role Description: We are seeking a highly motivated Senior Regulatory Affairs Associate who will lead and support regulatory projects across global markets, with a focus on Clinical Documentation – Clinical Evaluation & Investigations for CE/UKCA, EU MDR compliance, and medical device documentation. In this role, you will be managing client relationships, preparing regulatory submissions, and ensuring adherence to ISO and QMS standards. You will collaborate cross-functionally, support audits, and contribute to solution development for new business. Ideal for a proactive, detail-oriented professional seeking to grow in a dynamic regulatory consulting environment. Key Responsibilities: Regulatory Affairs: · Regulatory experience in preparing CER/CEP, technical files and supporting projects for CE/ UKCA in Europe. · 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. · 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 relationship’s 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, teams 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. Qualifications: · Advanced degree (Master’s or PhD) in a relevant field. · 5 years of 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. Why Join RegTrac? At RegTrac , you'll join a collaborative, supportive team that values expertise, curiosity, and purpose. The company fosters a culture of continuous learning, where your voice matters and your growth is actively supported through mentorship, diverse global projects, and real responsibility. You’ll be part of a close-knit community passionate about regulatory science and improving healthcare outcomes, with the flexibility to work remotely and balance life outside of work. At RegTrac, it’s not just about compliance—it’s about making a meaningful impact together, in a place where people genuinely enjoy what they do and who they do it with.
Company Overview RegTrac is a leading 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 diverse markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success. Role Description: We are seeking a highly motivated Senior Regulatory Affairs Associate who will lead and support regulatory projects across global markets, with a focus on Clinical Documentation – Clinical Evaluation & Investigations for CE/UKCA, EU MDR compliance, and medical device documentation. In this role, you will be managing client relationships, preparing regulatory submissions, and ensuring adherence to ISO and QMS standards. You will collaborate cross-functionally, support audits, and contribute to solution development for new business. Ideal for a proactive, detail-oriented professional seeking to grow in a dynamic regulatory consulting environment. Key Responsibilities: Regulatory Affairs: · Regulatory experience in preparing CER/CEP, technical files and supporting projects for CE/ UKCA in Europe. · 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. · 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 relationship’s 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, teams 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. Qualifications: · Advanced degree (Master’s or PhD) in a relevant field. · 5 years of 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. Why Join RegTrac? At RegTrac , you'll join a collaborative, supportive team that values expertise, curiosity, and purpose. The company fosters a culture of continuous learning, where your voice matters and your growth is actively supported through mentorship, diverse global projects, and real responsibility. You’ll be part of a close-knit community passionate about regulatory science and improving healthcare outcomes, with the flexibility to work remotely and balance life outside of work. At RegTrac, it’s not just about compliance—it’s about making a meaningful impact together, in a place where people genuinely enjoy what they do and who they do it with.