Regulatory Affairs Program Manager
About The Position
Regulatory Affairs Program Manager In this role you 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.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
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, leading regulatory compliance within the service, refurbishment, and supply chain domains, using regulatory information management (RIM) tools, and 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.
Benefits
- Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
