Philips Regulatory Affairs Program Manager 

United States, Massachusetts, Cambridge 

664338382

The Regulatory Affairs Program Manager will play a critical role within Philips Patient Safety & Quality Organization, responsible for enhancing tracking and controlling systems to optimize regulatory compliance monitoring and reporting efficiency, implementing robust systems and processes to ensure accurate and timely compliance of global Unique Device Identification (UDI) requirements.

Your role:

• Serves as a key liaison with external/internal stakeholders to maintain enterprise compliance globally for UDI. Comprehensive evaluations of the organization to assess its current level of regulatory excellence maturity, identifying strengths, weaknesses, and opportunities for improvement. Leads strategic initiatives towards enhanced performance to further improve regulatory compliance efforts and reviews the creation or modification of operational infrastructures to support strategic objectives and drive sustainable results.
• Leads programs/projects focused on regulatory compliance with UDI requirements, Computer System Validation (CSV) and process improvement by applying/utilizing lean tools- 6S, Kaizen, and continuous improvement methodologies to enhance performance, address regulatory challenges, problem solving techniques, management practices and drive organizational change.
• Responsible for comprehensive evaluations of the organization to assess its current level of Regulatory Excellence maturity, identifying strengths, weaknesses, and opportunities for improvement, thereby guiding strategic initiatives towards enhanced performance.
• Enhances tracking and control systems to optimize regulatory compliance monitoring and reporting efficiency, implementing robust systems and processes to ensure accurate and timely tracking of regulatory activities and ensures validation of regulatory affairs software tools.

You're the right fit if:

• You’ve acquired a minimum of 7+ years’ experience in Regulatory Affairs within Global FDA regulated medical device/technology environments, and a minimum of 3+ years’ experience successfully leading Regulatory Affairs program/project teams in maintaining Global enterprise compliance for Unique Device Identification (UDI).
• You have demonstrated Regulatory Domain knowledge/expertise in Unique Device Identification (UDI), ensuring traceability and facilitating better management throughout the product lifecycle, as well as desired experience in Computer System Validation (CSV) and knowledge in 510K, PMA, Technical Files/Design Dossiers, etc.
• You have strong experience in all aspects of program/project management, including planning, execution, developing program schedules, assigning resources, tracking/reporting on progress, managing budgets etc.
• You’re able to communicate, influence and build relationships with Internal/External Stakeholders at all levels.
• You have a minimum of a Bachelor’s Degree (Required) in Regulatory Affairs, Business Administration, Legal, Communications, Science or equivalent disciplines, Master’s degree desired. Desired certifications-RAPS-RAC, PMP/CAPM, Six Sigma Certified Change Management Professional (CCMP)
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

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.

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Philips Transparency Details:

• The pay range for this position in Cambridge, MA is $128,000 to $205,000.

Additional Information:

• 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.
• Company relocation benefits will not be provided for this position.
  For this position,
  you must reside in or within commuting distance to Cambridge, MA.
• May require travel up to 10%.