▷ [Only 24h Left] Team Lead - Compliance

for the Role of Team Lead - Compliance Job Title Team Leader - Compliance Department Compliance Location Ambernath Experience Required 7 Years Job Summary The Lead - Regulatory Compliance is responsible for ensuring that the organization s electronic medical and industrial devices comply with applicable domestic and international regulatory requirements This role demands strategic oversight of regulatory submissions audits training and quality system management including US FDA ISO 9001 2015 ISO 13485 2016 MDR 2017 745 MDR India and MDSAP The position acts as a key liaison between regulatory authorities and internal departments promoting a culture of compliance and continuous improvement Key Responsibilities 1 Regulatory Strategy Compliance Lead regulatory compliance efforts for medical and industrial electronic devices Develop and implement regulatory strategies for product launches and global market expansion Interpret and communicate evolving regulations e g US FDA ISO 13485 ISO 9001 MDR 2017 745 MDR India MDSAP to internal stakeholders Ensure timely submissions and approvals from relevant regulatory authorities 2 Product Lifecycle Documentation Manage product registrations submissions and approvals for national and international markets Maintain accurate documentation for audits inspections and regulatory submissions Ensure traceability and control of all quality and regulatory documents Oversee the implementation of regulatory requirements during product development and throughout the product lifecycle 3 Quality Management System QMS Oversight Ensure QMS is implemented maintained and aligned with ISO 9001 2015 ISO 13485 2016 MDR India MDR 2017 745 and MDSAP standards Promote awareness and compliance with regulatory requirements across departments Plan execute and document periodic internal audits and ensure corrective actions are completed Organize and lead Management Review Meetings MRM including agenda circulation evidence recording and action tracking Submit MRM reports to top management 4 Training Competency Management Train employees on regulatory compliance company policies procedures and best practices Ensure personnel are competent trained and qualified for their roles Conduct regular training sessions aligned with evolving standards and regulations 5 Stakeholder Collaboration Collaborate with cross-functional teams design production QA marketing to ensure products meet safety and regulatory expectations Liaise with external regulatory bodies notified bodies and industry associations Identify regulatory risks early and drive mitigation strategies 6 Risk Management Lead the development and maintenance of risk management files in accordance with ISO 14971 Identify assess and mitigate regulatory and product-related risks throughout the lifecycle Work cross-functionally to integrate risk controls into design manufacturing and post-market activities 7 Clinical Evaluation Oversee preparation and maintenance of Clinical Evaluation Reports CERs in compliance with MDR 2017 745 Evaluate clinical data to demonstrate product safety and performance Collaborate with medical experts R D and external partners to gather relevant clinical evidence Support Post-Market Clinical Follow-Up PMCF and surveillance activities as required 8 Regulatory Audits Inspections Prepare for and lead regulatory and customer audits US FDA inspections ISO audits etc Respond to audit findings and ensure timely implementation of corrective preventive actions 9 Continuous Improvement Risk Management Monitor industry trends regulatory changes and customer feedback to refine processes Identify gaps or weaknesses in compliance systems and recommend improvements 10 Confidentiality Integrity Ensure that all confidential documentation and records with business impact are protected Maintain integrity and transparency in all regulatory and compliance functions Qualifications Skills Bachelor s or Master s degree in Regulatory Affairs Quality Management or a related field Minimum 7 years of experience in regulatory compliance preferably in medical device or electronics manufacturing Proven knowledge and experience with ISO 9001 2015 ISO 13485 2016 MDR-2017 745 MDR India MDSAP and US FDA 21 CFR Part 820 510 K Strong leadership problem-solving and team management skills Experience in regulatory submissions audits and compliance for global markets Strong documentation organizational and project management skills Ability to interpret complex regulatory requirements and translate them into actionable policies Strong interpersonal and training abilities to lead cross-functional teams Hands-on experience with audits internal external QMS implementation and regulatory submissions Job Type Full-time Pay 400 000 00 - 1 204 891 35 per year Benefits Provident Fund Ability to commute relocate Ambernath Maharashtra Reliably commute or planning to relocate before starting work Preferred Experience ISO 13485 7 years Preferred Work Location In person