Regulatory Affairs Program Manager

Philips•Cambridge, MA

24d•Hybrid

About The Position

The Regulatory Affairs Program Manager is responsible to optimize regulatory compliance monitoring and reporting efficiency, implementing robust systems and processes to ensure accurate and timely tracking of regulatory activities, leading regulatory excellence and continuous improvement projects and programs. The role serves as a key liaison with external and internal stakeholders and undertakes comprehensive evaluations of the organization to assess its current level of regulatory excellence maturity, identifying strengths, weaknesses, and opportunities for improvement.

Requirements

Bachelor's Degree in Business Administration, Legal, Communications, Science or equivalent.
5+ years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as Regulatory Strategy, International Regulations, Medical Device Regulations, Project Management, Continuous Improvement or equivalent.
Ability to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
US work authorization is a precondition of employment.
Reside in or within commuting distance to Plymouth MN or Cambridge MA.

Nice To Haves

Masters degree preferred.
RAPS RAC, CAPM, Six Sigma, CCMP certifications desired.
One or more years of experience with validation of software tools.
One or more years of experience leading regulatory compliance within the service, refurbishment, and supply chain domains.
One or more years of experience using regulatory information management (RIM) tools.
One or more years of experience using UDI machine to machine software.

Responsibilities

Leads regulatory compliance in partnership with business unit affairs and other cross-functional partners in the areas of refurbishment, supply chain, and life cycle management activities.
Maintains key regulatory policies and guidances for the enterprise related to lifecycle management, refurbishment, remanufacturing, and supply chain.
Utilizes project and program management skills to lead projects focused on regulatory compliance and process improvement to enhance performance and drive organizational change.
Leads and supports validation of Regulatory Affairs IT platforms, performing the roles of tester, business process expert, and creating the deliverables.
Represents Regulatory Affairs Centralized Services in regulatory audits and certification meetings, participates in resolving audit findings, and ensures the appropriate deployment of Regulatory Affairs related processes and documents across the QMS.