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Job Title: Regulatory Specialist (ISO, CE, BIS Certifications & Audits)Job Summary:A Regulatory Specialist focusing on ISO, CE, BIS certifications, and audits plays a critical role in ensuring that products, services, and processes adhere to international standards and regulatory requirements. This specialist works with cross-functional teams to facilitate the certification process, manage audits, and ensure ongoing compliance with certification bodies. They ensure that the company meets regulatory requirements, helping maintain or achieve certifications in various industries such as manufacturing, healthcare, electronics, and more.Key Responsibilities:1. ISO Certification Management:Coordinate ISO Certification Process: Manage the process of obtaining and maintaining ISO certifications (e.g., ISO 9001, ISO 13485, ISO 14001) for relevant departments or products.Compliance Monitoring: Monitor the organization's compliance with ISO standards, ensuring continuous improvement and adherence to documented procedures.Documentation and Reporting: Prepare and maintain necessary documentation for ISO certification audits and re-certifications.2. CE Marking (European Conformity):CE Certification Process: Assist in obtaining and maintaining CE marking for products, ensuring that they meet European Union safety, health, and environmental requirements.Regulatory Guidance: Provide guidance on the European regulatory landscape and ensure that products comply with EU directives and standards, such as the Medical Device Regulation (MDR) or Low Voltage Directive (LVD).Submission to Notified Bodies: Prepare technical documentation and work with notified bodies to get products certified for CE marking.3. BIS (Bureau of Indian Standards) Certification:Manage BIS Certification Process: Facilitate the process for obtaining BIS certification for products and services in compliance with Indian standards.Liaise with BIS: Act as the primary point of contact for communication with the Bureau of Indian Standards, including the submission of applications and documentation for certification.Stay Updated on BIS Guidelines: Keep the organization updated on new BIS regulations, standards, and revisions that impact product certification.4. Audit Management:Conduct Internal Audits: Organize and conduct internal audits to evaluate compliance with ISO, CE, BIS, and other relevant standards.Coordinate External Audits: Facilitate and manage external audits conducted by certification bodies or regulatory agencies to assess the company's compliance with relevant standards.Corrective and Preventive Actions (CAPA): Identify non-compliance or areas for improvement during audits, and implement corrective and preventive actions (CAPA) in collaboration with relevant departments.Prepare Audit Reports: Document audit findings, track audit results, and report on the effectiveness of corrective actions.5. Regulatory Compliance & Documentation:Regulatory Documentation: Develop and maintain comprehensive compliance documentation, including certificates, audit reports, procedures, and quality manuals.Compliance Updates: Ensure that all regulatory documentation is updated in line with changing standards or regulations (ISO, CE, BIS, etc.).Legal and Industry Standards: Stay current with changes in international and national standards and regulations that may affect the company’s certifications.6. Training and Support:Employee Training: Conduct training sessions for internal teams to ensure understanding of ISO, CE, BIS, and audit requirements, emphasizing the importance of compliance and documentation.Cross-Department Collaboration: Work with product development, manufacturing, quality control, and management teams to ensure that all stages of product development and production comply with regulatory standards.7. Risk Management & Continuous Improvement:Risk Assessment: Identify potential regulatory risks and recommend strategies to mitigate risks related to non-compliance or certification failures.Continuous Improvement: Advocate for a culture of continuous improvement within the organization, supporting efforts to enhance product quality and compliance processes.Skills and Qualifications:Education:A bachelor’s degree in engineering, business, quality management, regulatory affairs, or a related field.Advanced certifications in regulatory affairs or quality management systems (e.g., Lead Auditor for ISO, ISO 9001, or ISO 13485 certification) are preferred.Experience:3-5 years of experience in regulatory affairs, quality management, or certification processes, preferably in industries such as manufacturing, electronics, healthcare, or automotive.Proven track record of managing ISO, CE, and BIS certifications and coordinating audits.Knowledge:Expertise in ISO 9001, ISO 13485, ISO 14001, CE marking process, and BIS certification requirements.Understanding of international regulatory standards (e.g., EU, US FDA, BIS) and their impact on product development, manufacturing, and quality control.Familiarity with risk management principles and corrective action procedures.Technical Skills:Proficiency in using Microsoft Office Suite (Excel, Word, PowerPoint) and quality management systems (QMS) or regulatory software tools.Strong documentation and report-writing skills.Soft Skills:Strong attention to detail and organizational skills.Excellent communication skills for collaborating with internal teams and external regulatory bodies.Ability to manage multiple projects simultaneously and meet deadlines.Problem-solving mindset with the ability to identify and address regulatory compliance issues.Work Environment:Regulatory specialists typically work in office settings but may need to travel for audits, inspections, or meetings with regulatory bodies.Industries employing Regulatory Specialists in ISO, CE, and BIS certification roles include manufacturing, automotive, electronics, healthcare, pharmaceuticals, and consumer goods.