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MedTech Business Development Director
2 months ago
Job Summary:
Tata Consultancy Services is seeking a highly experienced and skilled MedTech Business Development Director to join our team. As a key member of our organization, you will be responsible for driving business growth and development in the MedTech industry.
Key Responsibilities:
- Engage with TCS MedTech leaders in strategy definition and planning.
- Lead Medical Device Regulatory and Quality Offering and sales to MedTech Industries as part of Lifesciences & Healthcare group.
- Provide Industry Advisory to MedTech customers in Quality and Regulatory compliance.
- Act as an orchestrator across TCS COEs to identify best and most optimized team to work on client engagements, building team as revenue grows.
- Participate and represent TCS as a thought leader in roundtable and client discussions, continually raising TCS Brand and Subject Matter Expertise (SME).
- Lead executive level client steering committee meetings, manage conflict resolution among various stakeholders/staff to successfully support change management initiatives.
- Drive discovery exercises within medical devices organizations (customers) to baseline current regulatory environment, identify gaps, problems, concerns, develop roadmap to resolve such issues and execute comprehensive programs to implement the plan, monitor post-implementation.
- Where needed, in an owner or supporter role, RFP responses, drafts proposals, plans phased project execution, develops detailed project plans and manages program budgets and costs, fosters shared accountability for the results-based implementation plan.
Qualifications:
- Led Quality Assurance and Regulatory affairs activities for 5 new product development and 10 product sustenance programs.
- Experience in regulatory documentation, processes, quality assurance of medical devices across functional areas.
- Hands-on experience in 510K and PMA submissions.
- RAPS certified.
- Experience in Business strategy, Regulatory, Quality, R&D and Product strategies, managed regulatory concept and quality assurance: feasibility, requirements, usability, integration, testing/automation, verification, reliability, security, validation, post-market quality.
- Knowledge of Regulatory and Quality standards/frameworks in MedTech both Medical Devices and IVDFDA, EU MDD, MDR/IVDR, IEC 60601, ISO 13485, ISO 14971, ISO 62304.
- Knowledge of the end-to-end MedTech ecosystem and stakeholders.
- Strong team building skills, strategy, and operations thinking, solution & result orientation.
- Ability to travel 30-40%.
