![Philips](https://contents.bebee.com/companies/us/philips/avatar-BNuWf.png)
Senior Regulatory Project Manager
2 months ago
The Senior Regulatory Project Manager will play a critical role in ensuring Philips products are safe, reliable, and compliant, through managing critical initiatives focused on the collection, gap identification, impact assessment, gap closure/implementation planning activities and ensuring relevant QMS updates related to evolving medical devices standards.
Your role:
- In collaboration with the PMO, Product Leads and Core Team, develop, and Quality, design, implement, and manage technical development plans for all required programs (both pre/post market, this includes budgets, timelines and schedules, resources, business impact analysis, and status report out.
- Managing the Standard Compliance Programs while remaining current on standards affecting Philips products. Responsible for keeping the relevant team and supervisors informed about potential impact throughout the product's lifecycle. Provides inputs to Regulatory leadership to develop global regulatory compliance strategies. Responsible for the development and implementation of internal business processes and systems used to stay abreast of global standards to help Philips achieve our business goals within the scope of this position.
- Will manage projects focused on ensuring applicable medical device standards are understood and properly implemented within the Philips QMS. Maintains project data necessary to understand assumptions/progress made, and issues or risks associated with the projects. Organizes the archives of project information. Teaches project stakeholders how to effectively access information to help drive appropriate decisions. Provides technical guidance and training to Philips staff during strategy formulation, submission preparation and development of labeling, marketing, or promotional materials and in training on departmental policies and procedures related to Standards.
- Supports all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements. Responsible for owning and managing relevant CAPAs related to new and changing Standards implementation and compliance.
- Reporting to the Director of Regulatory Operations you will collaborate with functional area leaders and internal subject matter experts to lead the optimization of Philips QMS, including the product development and design controls processes to ensure that our customers have access to products maintained at State of the Art. Act as the liaison with aligned Corporate Philips teams and other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for standard compliance initiatives. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
You're the right fit if:
- You've acquired a minimum of 7 years' experience working in Regulatory Affairs within FDA regulated medical device/technology environments, with detailed knowledge in FDA, ISO, and EU regulations for Regulatory Submissions, complaint handling, reporting incidents, and implementing corrective and preventive actions.
- You have experience working in a broader enterprise/cross division business unit model (preferred), as well as strong organizational, planning/follow-up skills and ability to hold others accountable.
- You have proven leadership skills, including goal setting, providing positive/constructive feedback to build positive relationships and improve business results.
- Your skills include detailed knowledge and expertise in authoring FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), PMA, Technical Files/Design Dossier, etc.).
- You have a minimum of a Bachelor's Degree (required), Master's degree desired.
- You have demonstrated experience working in a highly matrixed, geographically diverse business environment and the ability to work effectively within a team in a fast-paced changing environment.
- You have the ability to communicate, influence and build relationships with Internal/External Stakeholders at all levels.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
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 either Cambridge, MA or Pittsburgh, PA.
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 our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
#LI-PH1
#LI-Hybrid
This 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/Disabled/Veteran and maintains a drug-free workplace.
-
Regulatory Affairs Senior Specialist
1 week ago
Cambridge, Massachusetts, United States Philips North America Full timeJob Title: Regulatory Affairs Senior SpecialistJob Description:In light of the pressing challenges our world faces today, the mission of Philips has never been more significant. If you share our commitment to enhancing lives, your contributions will be pivotal in shaping a more equitable future for everyone.In this position, you will have the opportunity...
-
Senior Manager of IT Shared Services
7 days ago
Cambridge, Massachusetts, United States New Directions, IT & Digital Talent Solutions Full timeJob OverviewPosition: Senior Manager of G&A Shared IT ServicesWe are seeking an experienced Senior Manager to oversee G&A Shared IT Services on a full-time basis. In this pivotal role, you will:Provide IT support for General and Administrative operations, including finance, compliance, regulatory affairs, human resources, and clinical trials.Enhance data...
-
Director, Global Regulatory Strategy, Oncology
3 months ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to support INT within the Oncology programs. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA oncology products as unprecedented new drug modality in...
-
Submissions Manager, Regulatory Operations
3 weeks ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Regulatory Operations Submission Manager is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The...
-
Senior IT Services Manager for G&A Functions
2 days ago
Cambridge, Massachusetts, United States New Directions, IT & Digital Talent Solutions Full timeJob OverviewPosition: Senior Manager, G&A Shared IT ServicesWe are seeking a proficient Senior Manager to oversee G&A Shared IT Services on a full-time basis. In this role, you will:Provide IT support for General and Administrative functions, including finance, compliance, regulatory affairs, human resources, and clinical trials.Enhance data management and...
-
Cambridge, Massachusetts, United States New Directions, IT & Digital Talent Solutions Full timeJob OverviewPosition: Senior Manager of G&A Shared IT ServicesWe are seeking a highly qualified Senior Manager to oversee G&A Shared IT Services on a full-time basis. In this pivotal role, you will:Provide IT assistance for General and Administrative operations, including finance, compliance, regulatory, HR, and clinical trials.Enhance data management and...
-
Ultrasound Regulatory Program Manager
1 month ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleUltrasound Regulatory Program ManagerJob DescriptionThe Program Manager provides operational leadership of programs, and are accountable for the development, delivery, and scheduling of projects in support of the Ultrasound Regulatory organization.Your Role: This role will oversee a variety of different programs within Ultrasound Regulatory Affairs;...
-
Head of Regulatory Strategy
6 days ago
Cambridge, Massachusetts, United States The Steely Group Full timeThe Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory leader who will guide drug development initiatives by leveraging extensive expertise to inform project teams on regulatory standards,...
-
Sr. Director, Regulatory Strategy
3 months ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy for the COVID-19 franchise to be based in its Cambridge headquarters or one of Modernas East Coast hubs. This role is intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market...
-
Head of Regulatory Affairs
6 days ago
Cambridge, Massachusetts, United States ONO PHARMA USA Full time**This position requires 3 days onsite in Cambridge**The role acts as a liaison with Health Authorities and serves as the Regulatory Project Leader for various initiatives at different stages of development. Responsibilities include:Strategic LeadershipProvides expert regulatory guidance for assigned drug development projects, leveraging extensive knowledge...
-
Regulatory Affairs Executive
7 days ago
Cambridge, Massachusetts, United States The Steely Group Full timeThe Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and as a leader in regulatory projects across various development phases. This position is essential for guiding drug development initiatives and leveraging extensive regulatory knowledge to support project teams in navigating complex...
-
Director, Global Regulatory Strategy
3 weeks ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna, Inc. is seeking a Director of Regulatory Strategy to develop and lead global strategy for mRESVIA, Modernas late stage / marketed RSV messenger RNA (mRNA) vaccine (Adult indication) to be based in one of Modernas East Coast hubs. The Global Regulatory Lead (GRL) role is intended for a forward looking, creative regulatory strategist able to...
-
Regulatory Affairs Executive
7 days ago
Cambridge, Massachusetts, United States The Steely Group Full timeThe Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory expert who will guide drug development initiatives, leveraging extensive expertise to inform project teams on compliance requirements and...
-
Regulatory Affairs Executive
7 days ago
Cambridge, Massachusetts, United States The Steely Group Full timeThe Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory leader who can effectively guide drug development initiatives by leveraging extensive expertise in regulatory frameworks.Key...
-
Cambridge, Massachusetts, United States Takeda Full timePosition OverviewAt Takeda, we are committed to pioneering advancements in research and development that lead to transformative therapies for patients. Our focus on four key therapeutic areas, along with targeted investments, allows us to redefine the possibilities in delivering life-altering treatments globally.As the Senior Director of Regulatory Affairs...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Sr. Manager of Regulatory Strategy to provide regulatory support for programs within the COVID-19 franchise and to be based in one of Modernas East Coast hubs. Their support includes but is not limited to managing INDs, marketing applications, and other regulatory submissions (orphan drug designations, pediatric plans, DSURs,...
-
Senior Biostatistics Manager
1 week ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeThe Opportunity:This position presents a unique chance to play a pivotal role within the clinical development team of a rapidly expanding organization. The Senior Biostatistics Manager will engage in the planning, execution, analysis, and reporting of clinical trials, particularly focusing on the organization's vaccine initiatives for infectious diseases....
-
Head of Regulatory Compliance
4 days ago
Cambridge, Massachusetts, United States The Steely Group Full timeThe Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and as a leader for various regulatory projects at different stages of development. This position requires a strategic mindset to guide drug development initiatives and ensure adherence to regulatory standards.Key Responsibilities:Oversees the...
-
Senior Medical Writing Manager
1 week ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeSenior Manager of Medical WritingThe Senior Manager of Medical Writing plays a pivotal role within the clinical development division at Moderna Therapeutics. This position reports directly to senior management and is responsible for producing high-quality clinical and regulatory documentation that aligns with the overarching goals of the clinical development...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing a unique class of therapeutic agents known as Bicycle molecules. These fully synthetic short peptides are designed with small molecule scaffolds, creating two loops that enhance their structural stability. This innovative design allows for high-affinity...