Regulatory Affairs Program Manager

Regulatory Affairs Program Manager 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. Your role: 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. You're the right fit if: Bachelor's Degree in Business Administration, Legal, Communications, Science or equivalent. Masters degree preferred. RAPS RAC, CAPM, Six Sigma, CCMP certifications desired. 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. Preferred experience: 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. 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. Philips Transparency Details The pay range for this position in Cambridge, MA is $137,000 to $190,000 annually. The pay range for this position in Plymouth, MN is $127,500 to $178,500 annually. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes generous PTO, 401(k) (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and more. Details about our benefits can be found. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 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 Plymouth, MN or Cambridge, MA. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. #J-18808-Ljbffr Mass Digital Health