Job Information
Philips Regulatory Affair Program Lead in Pune, India
Focus primarily on managing the standards and regulation roadmap and Leading improvements within the Image Guided Therapy systems (IGT-S) team. Understanding the regulations and standards is a plus not a must as this is not a regulatory content role.
Your role:
Program Manager for Regulatory Affairs plays a crucial role in ensuring that an organization's products and processes adhere to regulatory standards, and they work to establish and maintain positive relationships with other Program Managers.
The position requires a combination of regulatory knowledge, project management skills, and effective communication across various departments and with external stakeholders.
You are responsible for:
Work according to the business applicable processes and as ambassador of the Philips values.
Keeps abreast of current regulatory procedures and changes and driving these with the key SMEs across the company
Responsible for developing and implementing global RA roadmaps within IGT-S portfolio.
Collaborating with cross-functional teams spanning the globe in the business and markets in the chartering, initiation and executing of programs
Managing internal communications related to ensure clarity, agreement and efficiency which includes reporting out to IGTS Management Team and parts of the Philips Executive Committee
Driving best practice project management processes throughout projects and promote the consistent use of appropriate tools and methodologies.
Managing ongoing project coordination, risk, project dependencies and issue resolution and escalations.
You're the right fit if:
Strong communication skills
10+ years of experience in leading and managing programs using formal program & project management processes
5+ years of experience in continuous improvement activities
5+ years of experience in change management activities
Experience in relevant positions in medical device manufacturing organizations, professional services organizations, healthcare delivery organizations, or in consultancies serving those organizations highly preferred
Affinity with medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations.
Green belt/black belt certification (is plus)
Able to travel up to 20%
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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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 commitment to diversity and inclusion here.
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