About Medline:
About Medline India:
Medline India was set up in 2010 in Pune, primarily as an offshore Development center and to augment resources for Medline Industries LP headquartered in Chicago, USA. We are a 1500+ strong and growing team of technology, finance and business support professionals who support our businesses worldwide towards a mission to make healthcare run better. We are proud to be certified as a Great Place to Work by the Great Place to Work Institute (India) for the duration Jun 2025 Jun 2026
We are an organisation with a conducive work environment, ample opportunities to learn, contribute and grow with a highly empowered & engaged team. We encourage our people to share their best ideas and create new opportunities for our customers and ourselves to work together to solve today's toughest healthcare challenges.
About Medline Industries, LP:
Established in 1966, Medline Industries LP is a renowned global healthcare organisation boasting 56 years of consecutive sales growth, exceeding $21 billion in annual sales. With a workforce of over 36,000 professionals spread across the globe, we operate in more than 125 countries and territories. As the largest privately held manufacturer and distributor of medical supplies in the United States, Medline is uniquely positioned to offer comprehensive products, education, and support across the continuum of care.
At present, Medline Industries, LP holds the esteemed position as the #1 market leader, delivering an extensive portfolio of over 550,000 medical products and clinical solutions. Our clientele includes hospitals, extended care facilities, surgery centres, physician offices, home care agencies, providers, and retailers.
We're proud to be recognised by Forbes as one of America's Best Large Employers and Best Employers for Women. Additionally, the Chicago Tribune has consistently named us a Top Workplace for the past 12 years.
Job Description:
We are looking for a Regulatory Affairs professional to ensure compliance with international and local regulations for medical devices. The role involves supporting the preparation and maintenance of technical documentation, coordinating product certifications, and assisting with post market surveillance activities. The ideal candidate will help uphold regulatory standards and ensure timely, compliant product submissions. This role will report QRA Manager in India and the RA Manager in Europe/
Key Responsibilities-
- Compliance Management:
- Lead regulatory strategy for assigned product lines, ensuring compliance with EU MDR, ISO 13485, and applicable global regulations.
- Interpret regulatory requirements and translate them into actionable internal processes and documentation standards.
- Identify regulatory risks and propose mitigation strategies to support business continuity and product availability.
- Serve as the primary regulatory contact for distributors, partners, and competent authorities.
- Post Market Surveillance:
- Execute Post Market Surveillance (PMS) activities to ensure ongoing product safety and compliance.
- Validate distributed and imported products in line with regulatory and quality requirements.
- Manage and coordinate with distributors to ensure adherence to company and regulatory standards.
- Plan and conduct internal and external audits to maintain regulatory compliance and drive continuous improvement.
- Technical Documentation :
- Prepare, maintain, and update Technical Documentation in accordance with EU MDR 2017/745 Annex II & III requirements.
- Ensure completeness and regulatory conformity of the Technical File, including GSPR checklist, risk management documentation, clinical evaluation, and PMS/PMCF data.
- Coordinate cross-functional inputs to compile technical dossiers and ensure alignment with regulatory, quality, and engineering requirements.
- Cross-Functional Collaboration:
- Provide regulatory requirements and guidance to R&D during product design, updates, and change control.
- Work with QA to align on compliance, risk management, and technical documentation needs.
- Coordinate with Supply Chain to ensure regulatory readiness for imported/distributed products.
- Collaborate with global teams and distributors to ensure consistent regulatory alignment across regions.
- Support Marketing with claims review, labelling compliance, and timely approvals for product launches.
Secondary activities-
- Product Registrations & Certifications:
- Support CE marking activities by preparing and coordinating required regulatory documentation in alignment with EU MDR 2017/745.
- Assist in ISO 13485 certification and surveillance audits by ensuring documentation readiness and timely submission of required evidence.
- Manage medical device registrations with Competent Authorities, ensuring accuracy, compliance, and timely approvals.
- Maintain up-to-date records of certifications, registrations, and regulatory statuses across product portfolios.
- Regulatory Monitoring:
- Monitor global and local regulatory updates relevant to medical devices, including EU MDR 2017/745 and country-specific requirements.
- Assess regulatory changes and ensure timely updates to internal procedures, technical documentation, and compliance processes.
- Regulatory Database Maintenance:
- Maintain and update product regulatory databases to ensure accurate records of registrations, certifications, and compliance status.
- Manage and maintain up-to-date supplier files, ensuring all required documentation is complete and current (e.g., declarations, licenses, certifications)
- Support audits and regulatory submissions by providing accurate and readily accessible documentation from the database.
- Internal /External Audits:
- Participate in internal and external audits by providing required regulatory documentation and demonstrating compliance with applicable standards.
- Assist in addressing audit findings and implementing corrective actions to maintain ongoing regulatory compliance.
- Regulatory Watch:
- Monitor emerging regulatory trends, guideline updates, and changes impacting medical devices.
- Evaluate the relevance of regulatory changes and communicate actionable updates to internal stakeholders.
- Support proactive planning by informing teams about upcoming regulatory requirements or potential compliance risks.
Must Have-
- Bachelor's or higher Degree in Biomedical Engineering/Mechanical Engineering or a master's degree in pharmacy with specialisation in Quality Assurance.
- 5-7 years of experience in the medical device or healthcare industry with a strong quality background.
- Experienced in managing and executing product registration activities.
- Exposure to distributor audits or managing regulatory compliance for multi-country distribution networks.
- Strong understanding of EU MDR 2017/745, 21 CFR 820, ISO 13485, ISO 10993, ISO 11607 and applicable global regulatory requirements related to quality and compliance.
- Able to address audit findings and implement corrective actions.
- Demonstrates excellent communication skills to convey clear, concise messages and instructions to internal and external stakeholders, ensuring alignment and understanding.
- Demonstrates a strong focus on outcomes by setting clear goals, taking ownership, and consistently delivering high-quality results that align with business objectives.
Good to Have-
- Familiarity with global product registration pathways and requirements for the EU, Switzerland, and UK regions.
- Certified ISO 13485 Lead Auditor or Internal Auditor.
- Knowledge of EUDAMED, UDI requirements, and digital regulatory submission platforms.
- Experience with a complaint handling system, Rimsys, QAD, EtQ Reliance or any QMS software.
- Proven experience in handling audits by ensuring readiness, documentation accuracy, and timely resolution of findings
- Strong analytical abilities with attention to detail, thoughtful in considering all aspects of the problem and potential solutions
- Ability to work independently and in a global team environment.
- Good team player - Collaborates proactively across cross-functional teams and departments, driving alignment and contributing to high-impact, team-driven outcomes
Working Hours-
10.30 am to 7.30 pm
