Role: Business Development Director MedTech - Quality Assurance
Role Type: Full Time (No 3rd Party or Contractors)
Location: Chicago, IL
Compensation: Up to $183K DOE + Bonus
Year of Experience: 13+
Key Competencies: Business Development, MedTech, QA & RA, Medical Device Regulatory and Quality Offering, discovery exercises within medical devices, regulatory documentation, 510K and PMA submissions, RAPS certified.
Overview:
The role will be focused on Sales to relaunch the US Business and Practice. The sales Team will be led by a Chief Experience Officer with 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 at least 13 years of experience to serve as MedTech Business Development to our customer stakeholders. The 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.
A person must have an entrepreneurial spirit and the ability to expand the team as client adoption increases. Strong business acumen and the ability to interact with customers and client teams are necessary. Responsible for driving TCV (total contract value) sales target, maintaining a strong pipeline, and leading strategic C-Suite discussions that drive transformation projects. Ability to support and expand MedTech Device strategy, services roadmap, and solutions.
Responsibilities:
- Engage with 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 COEs to identify the best and most optimized team to work on client engagements—building team as revenue grows.
- Participate and represent as a thought leader in roundtable and client discussions. Continually raising 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 device organizations (customers) to baseline the current regulatory environment, identify gaps, problems, and concerns, develop a roadmap to resolve such issues, and execute comprehensive programs to implement the plan. Monitor post-implementation.
- Where needed, in an owner or supporter role, respond to RFPs, draft proposals, plan phased project execution, develop detailed project plans, and manage program budgets and costs; foster shared accountability for the results-based implementation plan.
Qualifications:
- A Bachelor's Degree is required.
- Led Quality Assurance and Regulatory Affairs activities for 5 new product development and 10 product sustenance programs.
- Experience in regulatory documentation, processes, and 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 IVD – FDA, 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%.
Job Type: Full-time
Pay: Up to $183,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Supplemental Pay:
Education:
Experience:
- Business development: 7 years (Required)
- Meditech: 5 years (Required)
- Quality Assurance: 3 years (Required)
- Product development: 4 years (Required)
- Regulatory affairs: 3 years (Required)
License/Certification:
- Regulatory Affairs Professionals Society Certification (Preferred)
Ability to Relocate:
- Chicago, IL: Relocate before starting work (Required)
Work Location: In person
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