Senior Manager - Quality & Regulatory

Job Title

Senior Manager - Quality & Regulatory

Job Description

Role Overview

The SQR Lead will serve as the Quality and Regulatory leader for Oral Healthcare sustaining, lifecycle-management and product-development activities supported from Pune. The role will partner with global OHC R&D, Procurement, Operations and Quality & Regulatory teams to strengthen product quality, regulatory compliance, supplier quality performance and effective portfolio execution, ensuring the delivery of safe, effective, and compliant OHC products throughout the product lifecycle. The leader will support quality strategy, regulatory deployment, risk management, governance and continuous improvement while building a capable, high-performing SQR team.

 

The Product Safety Quality Manager 70 is responsible for conducting seamless, in-depth safety assessments and compliance evaluations of product designs, overseeing the analysis of test data and root cause analysis to effectively resolve complex safety issues. The role acts as a principal advisor and subject matter expert on product safety and compliance matters, provides authoritative guidance to internal teams and external stakeholders. The role reviews and enhances product safety processes and procedures, optimizes operational efficiency and resource allocation to achieve departmental objectives effectively.

 

Key Responsibilities

• 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 across the site.
• 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 leading and supporting the regulatory inspections, notified-body assessments and external audits, while maintaining organizational 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 with internal and external requirements.
• Guide product and process risk-management activities across development, manufacturing and post-market phases, ensuring risks are identified, assessed, controlled and monitored throughout the lifecycle.
• Lead & support investigations, root-cause analysis, CAPA, nonconformance management and corrective actions, ensuring sustainable resolution of product, process and quality-system issues.
• Integrate customer feedback, reliability information, complaint trends and post-market surveillance data into product-development and lifecycle decisions, providing actionable feedback to design and manufacturing teams.
• Monitor quality-system, product and process performance metrics, using data-based insights to identify trends, manage emerging risks and drive strategic improvement priorities.
• Partner with R&D, Operations, Regulatory Affairs, Procurement and other functions to resolve quality issues, support business objectives and ensure effective execution of 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 appropriate 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, priorities and recommendations effectively to senior leadership and key stakeholders.
• Oversee the deployment of applicable global regulatory requirements and internal regulatory policies across OHC development and lifecycle-management activities, covering medical, non-medical.
• 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 is adequate to demonstrate product safety and compliance.
• Oversee regulatory submission planning, product licensing, maintenance of existing registrations and licenses, and regulatory change-control activities in partnership with Regulatory Affairs and market teams.
• Provide oversight for product labeling plans and the review and approval of product labeling and product-related marketing communications for regulatory and safety compliance.

You're the right fit if:

• You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
• You have a minimum of 15+ years’ overall experience in Product development lifecycle and 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.
• You have proven experience in functional management of quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
• You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
• You have 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.
• You have extensive experience in leading audit readiness, serving as the primary quality representative for regulatory inspections, external audits, and interactions with regulatory authorities and notified bodies and ensuring timely, effective responses to internal audits, regulatory inspections, and external assessments.
• You have proven experience utilizing Quality KPI’s/Data Analysis to assess project/team performance and identify process and continuous improvement opportunities.
• You have extensive experience leading CAPA/Nonconformance activities, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
• You have working knowledge of product safety and compliance standards relevant to OHC products, including IEC 60335, IEC 60601, electromagnetic compatibility and radio requirements.
• You have working knowledge of RoHS, REACH, global environmental requirements and biocompatibility principles under ISO 10993.
• You have experience working with certification bodies and supporting global product certifications, regulatory submissions and product-license maintenance.
  

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

About Philips
Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care.