Regulatory Affairs Program Manager

8w2 months ago

Philips

Plymouth, US · Full-time · $127,500 – $190,000

About this role

The Regulatory Affairs Program Manager optimizes regulatory compliance monitoring and reporting efficiency by implementing robust systems and processes. Ensures accurate and timely tracking of regulatory activities. Leads regulatory excellence and continuous improvement projects and programs.

Serves as a key liaison with external and internal stakeholders. Undertakes comprehensive evaluations of the organization to assess current regulatory excellence maturity levels. Identifies strengths, weaknesses, and opportunities for improvement.

Leads regulatory compliance in partnership with business unit affairs and cross-functional partners in refurbishment, supply chain, and life cycle management. Maintains key regulatory policies and guidances related to lifecycle management, refurbishment, remanufacturing, and supply chain. Utilizes project and program management skills to lead compliance and process improvement projects.

Leads and supports validation of Regulatory Affairs IT platforms as tester and business process expert. Represents Regulatory Affairs Centralized Services in audits and certification meetings. Works in an office-based team with at least 3 days in-person per week at Philips facilities.

Requirements

Bachelor's Degree in Business Administration, Legal, Communications, Science or equivalent; Master's degree preferred
RAPS RAC, CAPM, Six Sigma, CCMP certifications desired
5+ years of experience with Bachelor's OR minimum 3 years with Master's in Regulatory Strategy, International Regulations, Medical Device Regulations, Project Management, Continuous Improvement or equivalent
One or more years of experience with validation of software tools
Experience leading regulatory compliance within service, refurbishment, and supply chain domains
Experience using regulatory information management (RIM) tools
Experience with UDI machine to machine software
Ability to perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation for office/remote position

Responsibilities

Optimize regulatory compliance monitoring and reporting efficiency
Implement robust systems and processes for accurate tracking of regulatory activities
Lead regulatory excellence and continuous improvement projects
Lead regulatory compliance in partnership with business unit affairs and cross-functional partners in refurbishment, supply chain, and life cycle management
Maintain key regulatory policies and guidances for lifecycle management, refurbishment, remanufacturing, and supply chain
Utilize project and program management skills to lead regulatory compliance and process improvement projects
Lead and support validation of Regulatory Affairs IT platforms as tester, business process expert, and deliverable creator
Represent Regulatory Affairs in regulatory audits and certification meetings, resolve findings, and deploy processes across the QMS

Benefits

Work in office-based teams, in-person at least 3 days per week
Collaborate with cross-functional partners in a health technology company
Contribute to Philips' mission of quality healthcare access for everybody everywhere