Expert Medical Systems Products Drugs

Fresenius Medical Care; Bengaluru; On-site; INR 2,500,000 - 5,000,000; Full time

Job summary

Fresenius Medical Care in Bengaluru is seeking a senior Regulatory Medical Writer to lead the preparation and submission of medical and regulatory documentation. You will collaborate with therapy field directors and regulatory teams to ensure clinical evidence supports product development and market access.

Candidates should have a university degree in medicine, pharmacy, natural science, or related field, with 9+ years of regulatory writing and strong regulatory knowledge.

Qualifications

• At least 9 years of Regulatory Medical writing work experience.
• Knowledge of relevant regulations for drugs.
• Ability to compile medical/scientific documents and coordinate inputs.

Responsibilities

• Compile and update drug dossiers with clinical focus in alignment with therapy field director.
• Answer authorities on registration-related medical questions with regulatory input.
• Support drug development projects and participate in audits.
• Assist in risk management documentation for medico-regulatory topics.
• Collaborate in cross-functional teams for medical-regulatory aspects.
• Authorship of assessments on product development and clinical evidence needs.

Skills

Regulatory writing

Drug regulations knowledge

Scientific writing

Education

University degree in Medicine, Pharmacy, natural science, medical engineering or related science

Tools

Regulatory databases

Job description

Fresenius Medical Care:

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.

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

SQR:

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!

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Compilation and update of drug dossiers with focus on the clinical part in close alignment with the therapy field director


• Provide answers to authorities on registration related medical/pharmacological questions in close alignment with the director of the respective therapy field and with drug regulatory


• Support of drug development projects


• Participation in audits: support of therapy field leader with respect to therapy field relevant documents


• Supportive function in risk management, in particular concerning medico-regulatory topics: Provide support in the development, maintenance and updating of documents related to risk management deliverables


• Participation in cross-functional teams for medical-regulatory aspects


• Authorship of assessments concerning product development issues, in analysis of clinical data and in defining the medical evidence needed for driving or improving product development processes in close collaboration with the therapy field director


• Planning and support of medico-scientific activities related to generation of clinical evidence (studies) in close alignment with the respective director and Clinical Research


• Assessment of potentially relevant Literature within the frame of the literature vigilance process

EDUCATION:

University degree in Medicine, Pharmacy, natural science, medical engineering or related science

EXPERIENCE AND REQUIRED SKILLS:

• At least 9 years of Regulatory Medical writing work experience, preferably in a comparable position within health care or pharmaceutic or medical technology companies or research institutions


• Knowledge of relevant regulations for drugs


• Competence in the direct compilation of medical and scientific documents, and in the coordination and collection of contributions from various people/departments


• Experience in conducting systemic and process-oriented searches in medical and scientific databases


• Familiarity with relevant products and topics in the field of dialysis / nephrology (nice to have)

• Analytical intellectual capacity


• Self-motivated, responsible and structured working method


• Diligence and resilience


• Interactive and interdisciplinary approach


• Team player


• Good communicator


• Flexibility


• Good conflict resolution skills


• Intercultural competence