General Manager

Role/Summary: The General Manager Medical Affairs will lead Medical Affairs initiatives across clinical research, post-market surveillance, clinical education, medico-marketing, and medical strategy. The role will drive clinical evidence generation, KOL engagement, scientific communication, and collaboration with R&D, Quality, Regulatory, Marketing, and Sales teams to support product development, regulatory compliance, and business growth.

About Biorad Medisys- Biorad Medisys is a global medtech conglomerate focused on building strong capabilities across orthopedics, urology, robotics, and other clinical domains. The orthopedics vertical is a core growth engine, with a focus on implants, surgical solutions, and strong surgeon engagement across India and global markets

Job Responsibility:

A.Clinical Research & Data Management

• Informs Investigator Initiated Study (IIS) strategy and can act as a Single Point of Contact
• Leading the strategic planning, execution, and delivery of high-quality clinical data, ensuring accuracy for study reports, regulatory submissions, and internal decision-making. This oversees data management, programming teams, and vendor performance while ensuring compliance with global regulatory standards (ICH-GCP) and establishing data standards.
• Ensuring that clinical studies are compliant, ethical, scientifically robust, and completed on time and within budget. This role directly manages clinical operational teams, vendors (CROs), and site investigators.
• Responsible and Presentation for medical interpretation of data (clinical trials, registries, published literature) to internal & external stakeholders.

B.Post Market Surveillance and Complaint Handling

• Responsible for leading the strategic direction and daily operations of the Post Market Surveillance department, ensuring proactive monitoring of product safety, regulatory compliance (FDA/MDR), and quality improvement.
• Responsible for directing the strategic planning, generation, and dissemination of scientific data derived from clinical trials, post-market surveillance, and real-world evidence for medical devices. This involves leading a team to ensure all publications (journals, abstracts, posters) are scientifically accurate, high-quality, and compliant with Good Publication Practice (GPP) and international regulatory standards.
• Oversees the end-to-end management of customer grievances, ensuring compliance with global regulations. This leadership role involves driving root cause investigations, leading teams in reporting

adverse events, monitoring trends for corrective actions (CAPA).

• Collaborate with R&D, Product Development, Manufacturing, Quality Assurance, and other teams to implement corrective actions (CAPA).
• Determine reportability of complaints and submit Medical Device Reports (MDRs) to authorities.

C. Clinical Education

• Provides scientific/medical education to investigators, clinical monitors, internal and external stakeholders.
• Developing, implementing, and overseeing comprehensive clinical training programs for internal staff(sales, marketing, clinical specialists) and external customers (physicians, nurses, hospital technicalstaff).
• Strategizing & implementing so that training aligns with organizational goals, regulatory standards, and best practices for medical device safety and efficacy. The position involves leading a team of trainers, creating educational content, and evaluating the effectiveness of training to drive product adoption and compliance.
• Lead and manage the Clinical Training team to deliver training across various platforms (in-person, virtual, hands-on workshops).
• Create, update, and maintain high-quality training materials, including, e-learning modules, workshops, and simulator training, ensuring alignment with current clinical evidence.

D. Market Insights for R&D, Innovation Support

• Supporting clinical strategy for new product development, launch, and post-market surveillance. Bridging R&D, regulatory, and marketing to ensure scientific integrity, KOL engagement, and evidencegeneration.
• Collaborate with R&D to define clinical requirements, user needs, and product roadmaps, ensuring devices meet market needs.
• Identify and manage relationships with key thought leaders and surgeons to gain insights for new product launches.
• Serving on the product development committee to ensure that clinical development activities are consistent with the medical vision for Biorad Medisys and Group of Companies Product Segment.

E. Medico Marketing

• Develop clinical messaging, for sales teams, and educational material for HCPs.
• Review and approve promotional materials, ensuring medical accuracy and compliance
• Establishing and maintaining relationships with Key Accounts & leading Doctors as part of medical and scientific communication.
• Translate complex clinical trial data, studies, and regulatory requirements into actionable training content.
• Possess understanding of government and industry guidelines, regulations and laws for appropriate scientific/medical exchange and communication with customers

Behavioral Competencies:

• Scientific Understanding
• Excellent Communication Skills
• Team management, internal and external stakeholder communication
• Proactiveness
• Procedural Compliances
• Eye for detail