Vacancy expired!
Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees may request a reasonable accommodation. Montana employees are currently excluded from this requirement at this time.If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.In this role, you have the opportunity to make life better:The Senior Regulatory Project Manager will play a critical role in ensuring Global Regulatory compliance for Philips Sleep & Respiratory Care products, improving, and saving lives around the world.You are responsible for:
Work closely with Corporate Regulatory Affairs to identify new regulatory requirements.
Review and interpret new regulatory requirements and develop implementation plans.
Lead and report on Regulatory activities related to the implementation of new regulatory requirements.
Coordinate and Manage Regulatory Timelines for projects / products shared across different business units.
Participate in reviews of new and/or revised guidance’s, regulations, and standards applicable to the business unit.
Train business on new / revised guidance’s, regulations, and standards.
Manage and lead special regulatory focused projects and process improvements across the business.
Process leader for new projects such as PDLM, PQMS, etc.
Provide Regulatory Affairs Support for New Product Development, Sustaining, and Advanced Development efforts in both the domestic and international markets.
Provide direct project support for registration and licensing in mature markets and indirect support to the Emerging Markets group for all other licensing, as deemed necessary.
Lead and manage International Registration projects for complex countries (ex. Japan, Brazil, China) and interface between Business Marketing / Regulatory and In- Country Marketing / Regulatory
Identify areas for improvement for efficiency and compliance in the internal processes, work instructions, and forms and apply technical expertise to lead process improvement efforts on Hoshin and Improvement teams.
Maintain technical expertise in core Regulatory functions and secondary Quality functions including all applicable QSPs, WI, Forms, Philips training, and regulatory body requirements.
Train and Mentor Regulatory Personnel.
Conduct Business Unit Level Regulatory training for non-Regulatory personnel.
Maintain expertise in the interpretation of domestic and foreign regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned products, with a special focus on mature markets: USA, Canada, EU, Japan, and Australia.
Regulatory Intelligence analysis to domestic and foreign markets to identify trends in regulation interpretation and compliance issues.
You are a part of:The Regulatory Compliance team within Philips Sleep & Respiratory Care. Sleep and Respiratory Care drives integrated therapy solutions in the hospital and home environments, with a goal of improving diagnosis, treatment, and patient enablement across the healthcare spectrum. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.To succeed in this role, you’ll need a customer-first attitude and the following:
Minimum of a B.S. or B.A in an Engineering or Scientific discipline or equivalent required. Advanced degrees or certifications preferred. Project Management Certification (PMP) preferred.
Minimum of 7+ years’ experience in FDA regulated Medical Device/HealthTech environments with a focus in Regulatory Program/Project management.
Experience working with New Product Development Teams for assigned products, provides Regulatory analysis on the Product Development Plan and Interfacing with Business Unit functions as needed to resolve regulatory concerns.
Proven experience leading Project teams for Regulatory Projects with Business Unit Impact, to include the management of project team personnel, the development of an executable Quality Plan, coordination with partnering functions/departments/resources and the management of the associated schedule and budget.
Experience leading special regulatory projects and process improvement projects, including developing project plans and monitoring progress and completion for regulatory activities
Detailed experience in the Creation and execution of Regulatory Strategies and Plans for assigned products in the Domestic, Mature, and Emerging Markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers, including leading the review for new and revised guidance’s, regulations and standards
Strong experience in Design History File creation, review , and approval
Declaration of Conformity creation (MDD, MDR, RED,, RoHS, etc)
Regulatory assessments of Engineering Changes and Regulatory Assessment Checklist completion
Experienced in New Product Licensing and Registration submissions in the Domestic and Mature Markets (US, EU, CAN, AU)
Create and/or lift Regulatory Restrictions based on the Regulatory status of assigned products.
Experience Tracking pending domestic and global regulatory changes, develops and executes quality plans to minimize impact to the Business Unit
Maintains expertise in domestic and foreign regulations and standards, with a focus on assigned products and regional focus on the US (FDA), EU (MDD and/or MDR)
US work authorization is a precondition of employment. The company will NOT consider candidates who require sponsorship for a work-authorized visa.In return, we offer you:A path towards your most rewarding career. Philips is growing its capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.How we work at PhilipsOur newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.Our hybrid working model is defined in 3 ways:We believe in the importance of impactful collaboration : There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.Why should you join Philips?Philips is a global leader in health technology, committed to improving 2.5 billion of lives worldwide and striving to make the world healthier and more sustainable through meaningful innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 75,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.#LI-PH1It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran
