Description

You will lead the relaunch of the US MedTech business by driving sales, strategy, and regulatory advisory services.

Responsibilities

  • Drive Total Contract Value (TCV) sales targets and maintain a strong business pipeline through C-suite engagement.
  • Lead Medical Device Regulatory and Quality offerings to MedTech industries within the Life Sciences & Healthcare group.
  • Provide industry advisory to customers regarding Quality and Regulatory compliance and product development strategies.
  • Orchestrate cross-functional teams across COEs to optimize client engagements and scale teams as revenue grows.
  • Conduct discovery exercises to baseline regulatory environments, identify gaps, and execute implementation roadmaps.
  • Manage RFP responses, project proposals, phased execution plans, and program budgets.

Required Skills

  • Minimum of 13 years of industry experience with a focus on MedTech business development.
  • Proven track record leading Quality Assurance and Regulatory affairs for new product development and product sustenance programs.
  • Hands-on experience with 510(k) and PMA submissions.
  • Deep knowledge of regulatory and quality standards including FDA, EU MDD, MDR/IVDR, IEC 60601, ISO 13485, ISO 14971, and ISO 62304.
  • Expertise in regulatory concept and quality assurance covering feasibility, usability, verification, validation, and post-market quality.
  • RAPS certification.
  • Strong background in Sales, Account Management, and Contract Negotiation.
  • Ability to travel 30-40%.

Key Skills
Education

ANY GRADUATE

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