Quality and Regulatory Practice Leader

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. This is a great opportunity to build a career in the SAP QM domain. Interested candidates looking to grow in SAP QM are encouraged to apply. This role offers hands-on exposure to real-world SAP QM projects.

Required Skills & Experience 15–20 years of progressive experience in Quality and Regulatory Affairs within the medical device industry. Extensive, hands-on experience with global regulatory frameworks, including: 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. Education: Any Graduate. Location: Hyderabad, Pune, Bengaluru. Employment type: Full Time, Permanent. Candidates with strong communication skills and a willingness to learn are encouraged to apply. Freshers and experienced professionals meeting the above criteria are welcome to apply. Only candidates matching the required skill set and experience level will be considered.