Quality and Regulatory Practice Leader

Cyient Limited; Hyderabad, Pune District, Bengaluru; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Cyient Limited in Hyderabad seeks a seasoned Subject Matter Expert in Quality and Regulatory Affairs for medical devices. You will guide internal teams and clients, architect regulatory strategies across global markets, and drive winning proposals.

You will partner with Sales and Delivery, shape GTM offerings, and mentor teams while ensuring compliance with FDA, EU MDR/IVDR, PMDA, and CDSCO standards. This role demands strategic thinking and strong communication with senior stakeholders.

Qualifications

• 15–20 years of progressive experience in Quality and Regulatory Affairs in medical devices.
• Proven track record designing winning regulatory solutions, proposals and client presentations.
• Hands-on experience with global regulatory frameworks (FDA, EU MDR/IVDR, PMDA).

Responsibilities

• Serve as the primary Subject Matter Expert for Quality and Regulatory Affairs across medical device product lines.
• Architect end-to-end regulatory solutions for complex client problem statements.
• Lead the design and development of proposals and customer-facing presentations in response to RFPs, RFIs, and opportunities.
• Define and drive go-to-market strategy for quality and regulatory service offerings, identifying new opportunities and market positioning.
• Partner with sales, pre-sales, and delivery teams to craft differentiated value propositions and win themes for regulatory engagements.
• Advise clients on regulatory submission strategies across global markets including FDA, EU MDR/IVDR, PMDA, CDSCO, NMPA.
• Monitor evolving regulatory requirements across major geographies and translate changes into guidance.
• Support clients through the full product lifecycle from strategy to post-market surveillance.
• Build and mentor internal regulatory capability and playbooks.
• Represent the organization in client discussions and industry forums as a thought leader.

Skills

Regulatory affairs

Medical devices

Quality systems ISO 13485/14971

FDA regulatory knowledge

EU MDR/IVDR

Global regulatory expertise

Proposal design & storytelling

Leadership & mentoring

Cross-functional collaboration

Go-to-market planning

Job description

• 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.