Senior Manager - Quality & Regulatory

Overview

Lead the Quality and Regulatory function for Oral Healthcare sustaining, lifecycle-management and product-development activities supported from Pune, partnering with global OHC R&D, Procurement, Operations and Quality & Regulatory teams.

What you'll do

• Lead the OHC Quality and Regulatory function in Pune as a site leadership-team member, fostering a culture of quality, compliance, accountability and continuous improvement.
• Provide oversight of the Quality Management System and ensure alignment with applicable global requirements, including FDA QMSR, ISO 13485, EU MDR and other relevant regulatory and quality standards.
• Serve as the primary site Quality representative for regulatory inspections, notified-body assessments and external audits, maintaining audit readiness and ensuring timely, effective responses.
• Establish, maintain and continuously improve quality processes, systems, procedures and controls that support safe, effective, reliable and compliant products throughout their lifecycle.
• Lead design assurance and design control activities, including design inputs, quality planning, verification, validation, usability, reliability, manufacturability, safety, design transfer and process validation across hardware, software and system development.
• Ensure quality engineering documentation, including product and system quality plans, is accurate, current, risk-based and compliant.
• Guide product and process risk-management activities across development, manufacturing and post-market phases.
• Lead investigations, root-cause analysis, CAPA, nonconformance management and corrective actions.
• Integrate customer feedback, reliability information, complaint trends and post-market surveillance data into product-development and lifecycle decisions.
• Monitor quality-system, product and process performance metrics to identify trends, manage emerging risks and drive improvement priorities.
• Partner with R&D, Operations, Regulatory Affairs, Procurement and other functions to resolve quality issues and execute quality strategies and project milestones.
• Lead supplier-quality governance, including supplier qualification and development, audits, quality agreements, supplier changes, performance monitoring and corrective actions.
• Drive quality and operational-excellence initiatives using quality engineering, Lean, Six Sigma and other continuous-improvement methodologies.
• Lead and develop a high-performing quality organization through talent acquisition, objective setting, performance management, coaching, succession planning and employee development.
• Establish and manage departmental objectives, budgets, resource plans and performance goals, and communicate quality risks and recommendations to senior leadership and key stakeholders.
• Oversee deployment of applicable global regulatory requirements and internal regulatory policies across OHC development and lifecycle-management activities, covering medical and non-medical products.
• Provide governance for global product certification and conformity-assessment strategies, including coordination with certification bodies and test houses such as UL and DEKRA when required.
• Ensure regulatory requirements are translated into development plans and product requirements, and that verification and validation evidence demonstrates product safety and compliance.
• Oversee regulatory submission planning, product licensing, maintenance of registrations and licenses, and regulatory change-control activities with Regulatory Affairs and market teams.
• Provide oversight for product labeling plans and review and approval of product labeling and product-related marketing communications for regulatory and safety compliance.

What you'll need

• Minimum Bachelor's Degree (required) in Quality, Engineering or similar disciplines.
• Minimum 15+ years' overall experience in the product development lifecycle.
• Minimum 10+ years' experience in FDA-regulated Class 2 or Class 3 medical device environments, with a focus on Quality Management System (QMS) compliance and design assurance functions.
• Minimum 8 years of people management experience, with demonstrated capability in leading, developing and managing teams.
• Proven experience in functional management of quality teams, including budgeting, workforce planning, performance management, employee engagement/retention, succession planning, coaching and training.
• Strong understanding of medical device regulations and standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/EU MDR, GMP and GDP.
• Extensive experience managing design assurance activities throughout the product lifecycle, including design controls, risk management (ISO 14971, DFMEA/PFMEA), V&V, design transfer and process validation.
• Extensive experience leading audit readiness and serving as primary quality representative for regulatory inspections, external audits, and interactions with regulatory authorities and notified bodies, with timely, effective responses.
• Proven experience utilizing quality KPIs/data analysis to assess project/team performance and identify process and continuous-improvement opportunities.
• Extensive experience leading CAPA/nonconformance activities, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• Working knowledge of product safety and compliance standards relevant to OHC products, including IEC 60335, IEC 60601, electromagnetic compatibility and radio requirements.
• Working knowledge of RoHS, REACH, global environmental requirements and biocompatibility principles under ISO 10993.
• Experience working with certification bodies and supporting global product certifications, regulatory submissions and product-license maintenance.

Details

• Location: Pune.
• Work mode: Office-based, working in-person at least 3 days per week.