Senior Specialist - Regulatory Affairs (Gurgaon)

Senior Specialist - Regulatory Affairs

Introduction:

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 125,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.

Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation

Information about Systems, Quality & Regulatory (SQR) department:

Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide!

Summary about role:

Manage product related regulatory & quality activities e.g. registration submissions, renewals, change variations/notifications, PMS/PV activity, Regulatory Audits, adverse event/adverse drug reaction reporting, Pharmacovigilance responsible person, customer complaint handling, training, documentation management etc. in accordance with relevant regulations governing drug and device registrations in South Asia region.

Responsibility:

Your Responsibilities:

Main Activities:

• Responsible for Medical Device and Drug registration in CDSCO, State FDA office and other government office.
• Liaising with key health authority agencies during development, registration, and product lifecycle activities to resolve regulatory issues and/or negotiate approvals.
• Execution of Regulatory Submission plan. Manage Regulatory Information Management System (RIMS) to ensure all product information for medical devices and drugs is contemporaneous, accurate, and compliant to support uninterrupted market supply.
• Maintain up-to-date local registration dossiers, technical files, regulatory resources, and applicable legislation for both drugs and medical devices for India market.
• Provide regular updates in the Global Regulatory Roadmap and RIMS on the registration status of all products, including updates to the local country Roadmap.
• Implementation of Quality Management System (QMS) as part of a broader regional quality initiative.
• Ensure all labelling/ redressing activities are conducted in full compliance with Good Manufacturing Practice (GMP) requirements.
• Responsible for MRP implementation and NPPA compliance.
• Report customer complaints, incidents and any potential safety issues in compliance with corporate SOPs and execute medical device incident/adverse event reporting in compliance with local country regulations.
• Ensure audit and inspection readiness including preparation, realization and follow-up of external and internal audits and inspections. In case of detected deviations and non-conformities, ensure the effective, efficient and timely implementation of required corrections, corrective and/or preventive actions.
• Ensure safe, compliant and efficient release and distribution of products imported and marketed by FME within the distribution quality function. Ensure the fulfillment of GDP requirements for distribution of medical devices and drugs in all countries in hub
• Participate in monthly Quality and Regulatory Affairs (QaRa) meetings to provide regulatory compliance updates, share insights, and support cross-functional alignment.
• Responsible for timely, clear communications on regulatory status / issues / risks with key internal stakeholders esp. in Commercial Operations and Verticals, create transparency and thereby contribute to portfolio decisions through guidance on regulatory strategy and efforts.
• Manage and provide regulatory and quality support in the import/export of products and tender processes.

Relevant relations with other Areas:

• Internal Relations - Regulatory Affairs; Manufacturing & Supply Chain Quality, Commercial Operations; Verticals QARA, Technical Operations, Legal, Compliance, Marketing and Sales
• External Relations - Regulatory agencies, Distributors, customers, third party manufacturers and suppliers

Candidate’s profile:

Your Profile:

1) Education and qualifications required or expected

• Degree in Pharmacy, Chemical, Bioengineering, Health Professional.
• Desirable master’s degree in quality, regulatory, science or pharmacy
   

2) Professional Experience (in years):

• At least 5 years of Industrial experience in Medical Device or healthcare Industry and strong engagement HAs.
• Comprehensive expertise and knowledge of RA and applicable regulatory requirements in India.
• Extensive experience in leading negotiations with health authorities incl. experience with medical device registrations
• Solution-oriented mindset
• Excellent stakeholder management and communication skills.

3)  Other specialized knowledge required:

• Technical knowledge

• Knowledge in applicable norms as: CDSCO, Medical Devices Rules 2017, Legal Metrology, GMP-Good Manufacturing Practice, GDP, ISO 13485
• Plans and Aligns: Plans and prioritizes work to meet commitments aligned with organizational goals.
• Must be flexible and able to reprioritize according to business needs.

• Languages

• Fluency in English or native language (written and spoken)
   

• IT skills

• High Level on MS-Office and ability to adapt to new technologies.
   

• Other skills

• Desirable knowledge in MedTech

4) Relevant skills / competencies for the position:

• Skills in interpersonal communication and Training.
• Balances Stakeholders: Anticipates and balances the needs of multiple stakeholders.
• Demonstrated interpersonal skills including strong negotiation skills.
   

Offer package:

Our Offer for you:

There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have -  all dedicated to your professional journey.

• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
• A large number of committed people with a wide range of skills, talents and experience
• The benefits of a successful global corporation with the collegial culture of a medium-sized company