Position Details: Director Business Development MedTech QA & RA Solutions-EIS : Me

This is a new role & group within TCS that will be focused on Sales to relaunch the US Business and Practice.  Sales Team will be led by Chief Experience Officer with over 20 years of C- level, GM, and Business Development experience in Medical Devices, AI, System Technology and Pharmaceuticals, including 6+ years of entrepreneurship.    

We’re looking for a passionate and driven senior Industry leader with a minimum of 13 years experience to serve as MedTech Business Development  to our customer stakeholders.  Candidate will consult on our product development strategies, accelerate offerings, and design for next generation solutions.   Further, they will provide technical leadership, guide engineering and development for complex medical devices equipment/systems, and work with functional areas across the organization (MedTech COE, AI COE, Manufacturing, R&D/NPI, Quality & Regulatory) to deliver best-in-class solutions and capabilities.

Person must have an entrepreneurial spirit and ability to expand team, as client adoption increases.  Strong business acumen and ability to interact with customers and client teams is a must. Responsible for driving TCV (total contract value) sales target, maintain strong pipeline and lead strategic C-Suite discussions that drive transformation projects. Ability to support and expand MedTech Device strategy, services roadmap and solutions. 

Responsibilities:  

1. Engage with TCS MedTech Leaders in strategy definition and planning.

2. Lead Medical Device Regulatory and Quality Offering and sales to MedTech Industries as part of Lifesciences & Healthcare group.

3. Provide Industry Advisory to MedTech customers in Quality and Regulatory compliance.

4. Act as an orchestrator across TCS COE’s to identify best and most optimized team to work on client engagements—building team as revenue grows.

5. Participate and represent TCS as a thought leader in roundtable and client discussions. Continually raising TCS Brand and Subject Matter Expertise (SME).

6. Leads executive level client steering committee meetings; can manage conflict resolution among various stakeholders/staff to successfully support change management initiatives.

7. 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.

8. 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: 

1. Led Quality Assurance and Regulatory affairs activities for 5 new product development and 10 product sustenance programs 

2. Experience in regulatory documentation, processes, quality assurance of medical devices across functional areas. 

3. Hands on experience in 510K and PMA submissions

4. RAPS certified.

5. 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.

6. Knowledge of Regulatory and Quality standards/frameworks in MedTech both Medical Devices and IVD – FDA, EU MDD, MDR/IVDR, IEC 60601, ISO 13485, ISO 14971, ISO 62304

7. Knowledge of the end-to-end MedTech ecosystem and stakeholders

8. Strong team building skills, strategy, and operations thinking, solution & result orientation.

9. Ability to travel 30-40%

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