Senior Industry Success Consultant (Medical Device Regulation)

ABOUT THE ROLE

In this role, you will act as a Medical Device Regulatory SME, supporting client engagements across the medical device product lifecycle. Working within SoftServe’s HCLS Business Consulting Group, you will connect deep regulatory knowledge with SoftServe’s digital capabilities to help medtech and life sciences organizations navigate complex compliance challenges and reduce time-to-market.

RESPONSIBILITIES

• Advise clients on device classification, regulatory strategy, and submission preparation (510(k), PMA, De Novo, or equivalent), identifying the most efficient pathway based on device type, intended use, and risk profile
• Advise on post-market surveillance obligations, including MDR/MDV reporting requirements, complaint handling processes, and corrective action frameworks
• Provide guidance on software as a medical device (SaMD) and digital health regulatory considerations, including FDA’s software guidance frameworks and risk-based classification approaches
• Review and validate documented requirements to ensure alignment with applicable regulatory standards, design controls, quality system requirements, and the client’s operating model
• Provide guidance to delivery teams on regulatory context and compliance requirements to ensure solutions are fit for purpose in regulated environments
• Conduct stakeholder interviews, workshops, and process discovery to capture current regulatory practices, identify gaps, and understand clients’ compliance challenges and operational objectives
• Perform industry-focused research and analysis to support regulatory strategy, solution shaping, and client decision-making across the product development and approval lifecycle
• Support creation of client deliverables including regulatory assessments, gap analyses, compliance roadmaps, playbooks, and Points of View (POVs)
• Support RFP/RFI responses and pre-sales proposals by contributing regulatory domain expertise and shaping solution narratives relevant to medtech clients
• Build trust-based relationships with client stakeholders; collect and evaluate feedback on implemented solutions to identify risks, improvements, and additional service opportunities

REQUIREMENTS

• 5-7 years of experience with a direct focus on medical device regulatory affairs, quality, or compliance.
• Hands-on experience with medical device regulatory processes, including device classification, pre-submission activities, technical documentation, and submission preparation for FDA (510(k), PMA, De Novo)
• Working knowledge of design controls, quality system requirements, and post-market surveillance obligations applicable to medical device development and commercialization
• Familiarity with SaMD and digital health regulatory frameworks
• Experience with process analysis, structured problem-solving, and creation of requirements specifications or regulatory deliverables
• Ability to translate complex regulatory requirements into actionable recommendations for both technical and business audiences
• Excellent communication, presentation, and facilitation skills