- Serve as the primary Subject Matter Expert for Quality and Regulatory Affairs across medical device product lines, providing strategic guidance to internal teams and clients.
- Architect end-to-end regulatory solutions for complex client problem statements, translating business needs into actionable regulatory strategies.
- Lead the design and development of winning solutions, proposals, and customer-facing presentations in response to RFPs, RFIs, and strategic business opportunities.
- Define and drive go-to-market (GTM) strategy for quality and regulatory service offerings, identifying new business opportunities and market positioning.
- Partner with sales, pre-sales, and delivery teams to craft differentiated value propositions and win themes for regulatory consulting engagements.
- Advise clients on regulatory submission strategies, including 510(k), PMA, De Novo, EU MDR technical documentation, and emerging requirements under the EU AI Act.
- Monitor and interpret evolving regulatory requirements across FDA (US), EU MDR/IVDR, PMDA (Japan), CDSCO (India), NMPA (China), and other major geographies, translating changes into actionable guidance.
- Support clients through the full product lifecycle – from regulatory classification and strategy through submission, approval, and post-market surveillance.
- Build and mentor internal regulatory capability, establishing best practices, templates, and playbooks for proposal development and client delivery.
- Represent the organization in client discussions, workshops, and industry forums as a thought leader in medical device quality and regulatory affairs.
- Collaborate with cross-functional teams (Quality, Clinical, Engineering, Legal) to ensure proposed solutions are technically sound and compliant.
Required Skills & Experience
- 15–20 years of progressive experience in Quality and Regulatory Affairs within the medical device industry.
- Proven track record of creating winning solutions, proposals, and customer presentations for regulatory consulting or managed-services engagements.
- Extensive, hands-on experience with global regulatory frameworks, including:
- US FDA – 510(k), PMA, De Novo pathways
- European Union – EU MDR, EU IVDR, and the EU AI Act
- Japan – PMDA requirements and approval processes
- India – CDSCO regulations
- China – NMPA regulations, and other emerging geographies
- Deep expertise in quality management systems (ISO 13485, ISO 14971) and their application to regulatory submissions.
- Demonstrated ability to architect solutions for complex, multi-geography regulatory problem statements.
- Strong experience responding to complex RFPs – including solution design, pricing strategy input, and executive-level storytelling.
- Excellent client-facing communication, presentation, and negotiation skills, with experience engaging C-suite and senior stakeholders.
- Strong business acumen with the ability to connect regulatory strategy to commercial outcomes and go-to-market planning.
- Experience mentoring teams and building organizational regulatory capability and thought leadership.