Senior Specialist – Regulatory Affairs | Fresenius Medical Care | Gurgaon, India
Location: Gurgaon, Haryana, India
Work Model: Hybrid
Company: Fresenius Medical Care
Department: Systems, Quality & Regulatory (SQR)
Employment Type: Full-Time
Experience Required: Minimum 5 Years
Education Required: Bachelor’s Degree in Pharmacy, Chemical Engineering, Bioengineering, Life Sciences, or a Related Healthcare Discipline (Master’s Degree Preferred)
About Fresenius Medical Care
Fresenius Medical Care is a global leader in kidney care, dedicated to improving the lives of patients with chronic kidney disease. The company delivers innovative medical products, advanced therapies, and digital health solutions that support healthcare professionals and improve patient outcomes worldwide.
With a workforce of over 125,000 employees globally, Fresenius Medical Care operates with the vision of creating a future worth living for patients everywhere. The organization focuses on innovation, quality, and regulatory excellence to ensure safe and effective healthcare solutions throughout the patient care journey.
Within the Care Enablement segment, the Systems, Quality & Regulatory (SQR) department plays a critical role in maintaining product safety, quality standards, and regulatory compliance throughout the product lifecycle. The team supports global operations through regulatory governance, post-market surveillance, and continuous quality improvement initiatives.
Job Overview
Fresenius Medical Care is seeking a Senior Specialist – Regulatory Affairs to manage regulatory and quality activities for medical devices and pharmaceutical products in the South Asia region. The role is responsible for ensuring regulatory compliance, product registrations, post-market surveillance, and pharmacovigilance activities while supporting product lifecycle management.
The position requires strong expertise in regulatory submissions, health authority engagement, and regulatory compliance with Indian medical device and pharmaceutical regulations.
Key Responsibilities
Regulatory Strategy and Product Registration
Manage medical device and drug registration activities with regulatory authorities including CDSCO, State FDA offices, and other government agencies.
Prepare and submit regulatory dossiers, renewal applications, variations, and notifications in accordance with applicable regulatory requirements.
Liaise with regulatory authorities during product development, registration, and lifecycle management to resolve regulatory issues and facilitate approvals.
Maintain up-to-date registration dossiers, technical documentation, and regulatory records for products marketed in India.
Regulatory Submission and Data Management
Execute regulatory submission plans and ensure timely approvals to support uninterrupted product supply.
Manage the Regulatory Information Management System (RIMS) to ensure accurate and compliant product information.
Update the Global Regulatory Roadmap and local regulatory plans with the latest product registration status.
Quality and Compliance Management
Support the implementation and maintenance of the Quality Management System (QMS) in alignment with regional quality initiatives.
Ensure labeling and packaging compliance with Good Manufacturing Practice (GMP) requirements and local regulatory standards.
Ensure compliance with Medical Device Rules 2017, Legal Metrology regulations, GDP, and ISO 13485 standards.
Pharmacovigilance and Post-Market Surveillance
Manage pharmacovigilance responsibilities including adverse event reporting, incident reporting, and customer complaint handling.
Ensure compliance with corporate SOPs and local regulatory requirements for safety reporting.
Participate in post-market surveillance activities to maintain product safety and regulatory compliance.
Regulatory Audit and Inspection Readiness
Prepare for internal and external regulatory audits and inspections.
Address regulatory deviations or non-conformities through corrective and preventive actions.
Ensure continuous compliance with regulatory standards across product lifecycle activities.
Regulatory Operations and Stakeholder Communication
Provide regular updates to internal stakeholders on regulatory status, risks, and approval timelines.
Support cross-functional collaboration with teams including manufacturing, supply chain quality, commercial operations, marketing, legal, and compliance.
Participate in Quality and Regulatory Affairs meetings to provide regulatory insights and support decision-making.
Import, Export, and Market Access Support
Provide regulatory and quality support for product import and export activities.
Assist in regulatory requirements related to tender submissions and product commercialization processes.
Ensure compliance with MRP implementation and NPPA regulatory requirements.
Required Skills and Competencies
Strong knowledge of Indian regulatory frameworks including CDSCO regulations and Medical Device Rules 2017.
Experience with regulatory submissions, product registrations, and lifecycle management for medical devices or pharmaceutical products.
Familiarity with regulatory systems such as Regulatory Information Management Systems (RIMS).
Strong stakeholder management and negotiation skills when interacting with regulatory authorities.
Excellent documentation, analytical, and communication skills.
Ability to manage multiple regulatory projects while maintaining regulatory compliance.
Education Requirements
Bachelor’s degree in Pharmacy, Chemical Engineering, Bioengineering, Life Sciences, or a related healthcare discipline.
A Master’s degree in Regulatory Affairs, Quality Management, Pharmacy, or Life Sciences is preferred.
Experience Requirements
Minimum 5 years of regulatory affairs experience in the pharmaceutical, medical device, or healthcare industry.
Demonstrated experience working with Indian health authorities including CDSCO and State FDA offices.
Experience in medical device registrations, regulatory submissions, and regulatory compliance management.
Strong understanding of regulatory frameworks such as GMP, GDP, ISO 13485, and pharmacovigilance requirements.
Technical and IT Skills
Proficiency in Microsoft Office applications including Word, Excel, and PowerPoint.
Experience working with regulatory management systems and digital documentation platforms.
Ability to adapt to new regulatory technologies and data management tools.
Language Requirements
Fluency in English, both written and spoken, is required.
Why Join Fresenius Medical Care
Fresenius Medical Care offers an opportunity to work in a global healthcare organization dedicated to advancing patient care and medical innovation. Employees benefit from a collaborative environment that encourages professional growth, innovation, and knowledge sharing.
The company provides strong career development opportunities, exposure to global healthcare projects, and the resources needed to build a meaningful career in regulatory affairs and healthcare innovation.a
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
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Siliguri |Illinois :
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