Regulatory Affairs Program Manager

Job Title

Regulatory Affairs Program Manager

Job Description

As a Regulatory Affairs Program Manager, you will be an important member of the Philips Regulatory Affairs Centralized Services Team, committed to improving billions of lives worldwide.

Your role:

• Will own and manage the Philips wide strategy and execution of FDA Establishment Registrations and Listings across the enterprise.

• Maintain controlled processes and guidance documents for FDA Establishment Registrations and Listings in the shared services quality management system.

• Partner with the business units to ensure they have compliant processes regarding FDA Establishment Registrations and Listings in their local quality management systems.

• Provide FDA Establishment Registrations and Listings information to the US Trade and Compliance team.

• Work with other regulatory affairs data owners to ensure timely compliance of changes or additions of regulatory data elements across all internal and external IT platforms.

• Lead continuous improvement, including enabling automation and other technologies to reduce administrative tasks.

• Manage projects to meet schedule, cost, and quality requirements to enable the strategic vision of the regulatory affairs organization.

• This Hybrid role may require travel up to 10%.

You're the right fit if you have the following:

• You acquired a minimum of 5 years' experience in regulatory affairs within the FDA regulated, global medical device industry.

• You have extensive knowledge of US FDA Regulations, with a focus on 21 CFR Part 807.

• You have experience using the FDA Unified Registration and Listing System (FURLS)-Required

• You have proven Project management experience, PMP or other project management certification- preferred

• You're strong in influencing and building relationships.

• You have the ability to effectively prioritize and execute tasks in a high-pressure environment and work proactively to ensure deliverables are met

• You're experienced in leading continuous improvement initiatives.

• You have strong experience writing and maintaining QMS processes- preferred

• You have a minimum of a Bachelor's degree, preferably in a life science discipline (Required), Master's Degree preferred

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

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 improve the lives of others.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

• Read more about our employee benefits.

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.

Philips Transparency Details:

The pay range for this position is $104,000 to $178,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.