Job Title
Sr. Manager Regulatory Affairs (Medical Devices) – Bangalore
Job Description
Job title:
Sr. Manager Regulatory Affairs
In this role, you have the opportunity to
We are seeking a dynamic and experienced Regulatory director to drive strategic regulatory initiatives, ensuring compliance and excellence across global business units. This individual will lead a team of 10+ professionals, focusing on Corrective and Preventive Actions (CAPAs), and sustaining business operations. The ideal candidate possesses deep expertise in regulatory affairs, strategic process optimization, and global regulatory policy development. This role significantly impacts organizational success, influencing regulatory outcomes, site leadership strategies, and business continuity.
You are responsible for
- Lead and mentor a team of 10+ regulatory professionals, fostering a culture of excellence and continuous improvement.
- Develop and implement long-term regulatory optimization and streamlining initiatives to enhance compliance and business efficiency.
- Provide strategic leadership in global regulatory matters across diverse product categories, including medical device classes, and software.
- Drive the development and influence of global regulatory policies to align with evolving industry standards.
- Oversee the authoring and submission of regulatory documentation, including FDA Pre-Submissions, 510(k)s, and Technical Files/Design Dossiers.
- Define and execute short to mid-term (1-3 years) regulatory strategy in alignment with organizational objectives.
- Serve as a key site leader, ensuring regulatory compliance and driving sustainable business practices.
- Plan, staff, budget, and manage priorities for the regulatory function while proposing and implementing methodological improvements.
- Lead succession planning and talent management initiatives, including employee selection, performance management, compensation management, and career development.
- Address complex regulatory and business challenges, collaborating across functions and regions to drive favorable outcomes.
- Influence senior management, executives, and key stakeholders, negotiating matters of strategic significance.
- Ensure financial and operational effectiveness within the regulatory function, impacting overall business performance and compliance success.
You are a part of
The global Philips regulatory organization and will be reporting to the Head of Regulatory Affairs for Image Guided Therapy Systems (IGT-S) in the Netherlands. The team you will be working in, is a high-performance, culturally diverse, and very dynamic team.
To succeed in this role, you should have the following skills and experience
- Bachelor’s or Master’s Degree in Biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law, or a related field.
- 10-12 years of experience in Regulatory Affairs, or Product Development within the Medical Device Industry (or equivalent).
- 6-8 years of management experience, leading regulatory teams in a global environment.
- Proven ability to develop and implement regulatory strategies, optimize compliance processes, and drive business continuity.
- Extensive knowledge of global regulatory requirements and experience authoring regulatory submissions.
- Strong leadership, communication, and negotiation skills, with the ability to influence senior executives and key stakeholders.
- Experience in managing complex regulatory challenges, collaborating across business units, and ensuring successful regulatory outcomes.