Description

Lead the relaunch of the US MedTech business by driving sales, strategy, and technical advisory for Quality and Regulatory solutions.

Responsibilities

• Drive total contract value (TCV) sales targets and maintain a strong pipeline through strategic C-Suite discussions.
• Consult with MedTech customers on regulatory compliance, product development strategies, and service roadmaps.
• Orchestrate cross-functional teams across AI, Manufacturing, R&D, and Quality COEs to deliver client engagements.
• Lead discovery exercises to baseline regulatory environments, identify gaps, and execute implementation programs.
• Manage executive-level steering committees, RFP responses, and project budgets to support change management.

Required Skills

• Minimum 13 years of industry experience with a focus on MedTech, Medical Devices, or Pharmaceuticals.
• Hands-on experience with 510K and PMA submissions.
• Proven track record leading QA and RA activities for new product development and product sustenance programs.
• Deep knowledge of regulatory standards including FDA, EU MDD, MDR/IVDR, IEC 60601, ISO 13485, ISO 14971, and ISO 62304.
• Expertise in regulatory documentation, feasibility, usability, verification, validation, and post-market quality.
• Proficiency in Sales, Lead Generation, Account Management, and Contract Negotiation.
• RAPS certification.
• Ability to travel 30-40%.

Key Skills

Education

ANY GRADUATE