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Manager of Regulatory Affairs Programs

2 months ago

Cambridge, Ohio, United States Philips International Full time


As a Manager of Regulatory Affairs Programs, you will play a pivotal role within the Philips Regulatory Affairs Centralized Services Team, dedicated to enhancing the quality of life for individuals globally.


Your Responsibilities:
• Oversee and direct the comprehensive strategy and implementation of FDA Establishment Registrations and Listings throughout the organization.
• Maintain structured processes and guidance documents for FDA Establishment Registrations and Listings within the shared services quality management system.

• Collaborate with business units to ensure adherence to compliant processes regarding FDA Establishment Registrations and Listings in their respective quality management systems.

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

• Coordinate with other regulatory affairs data stewards to ensure prompt compliance with changes or additions of regulatory data elements across all internal and external IT platforms.

• Drive continuous improvement initiatives, including the adoption of automation and other technologies to minimize administrative burdens.
• Manage projects to fulfill schedule, cost, and quality objectives, aligning with the strategic vision of the regulatory affairs division.
This hybrid position may involve travel up to 10%.
Qualifications:
• A minimum of 5 years of experience in regulatory affairs within the FDA-regulated global medical device sector.
• In-depth knowledge of US FDA Regulations, particularly 21 CFR Part 807.
• Experience with the FDA Unified Registration and Listing System (FURLS) is essential.
• Proven project management experience; PMP or similar certification is preferred.
• Strong skills in influencing and relationship building.
• Ability to prioritize and execute tasks effectively in a high-pressure environment, ensuring deliverables are met proactively.
• Experience in leading continuous improvement efforts.
• Strong background in writing and maintaining QMS processes is preferred.
• A minimum of a Bachelor's degree in a life science discipline is required; a Master's degree is preferred.
• US work authorization is a prerequisite for employment. The company will not consider candidates requiring sponsorship for a work-authorized visa, now or in the future.

About Philips:
Philips is a health technology company committed to ensuring that every individual has access to quality healthcare.

We strive to make a meaningful impact on people's lives through innovation and technology.

Discover more about our business, our rich history, and our purpose.

We value diversity and inclusion in our workplace and encourage individuals with varied experiences to apply.


Philips Transparency Details:
The compensation range for this position is between $104,000 and $178,000 annually.

The actual base pay offered may vary based on factors such as job-related knowledge, skills, experience, business needs, geographical location, and internal equity.

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