Regulatory Affairs Program Manager
$137k - $190kPhilips International
- ## Job TitleRegulatory Affairs Program Manager### Job Description**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.**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 position.**How we work together**We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.This is an office role.**About Philips**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.* Learn more about .* Discover* Learn more about* Learn more about**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 a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much 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.#LI-PHIThis requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.*Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.*At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.*It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.**To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact View phone number on click.appcast.io, option 5, for assistance.**Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.*
- J-18808-Ljbffr Philips International
Vacancy posted 4 days ago
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