Current jobs related to Regulatory Affairs Program Manager - Canada, CA - Philips International

  • Regulatory Affairs Associate

    4 days ago

    Canada, CA MY01 Full time

    *La version française suitFounded in 2019 and based in Montreal, MY01 envisions a world where every disease is quantifiable, enabling precise, personalized care for all patients. Specializing in managing limb ischemia and compartment syndrome, our tools provide proactive monitoring and actionable insights through a connected care team that benefits...

  • Senior Regulatory Affairs Specialist

    4 days ago

    Canada, CA MY01 Full time

    *La version française suitFounded in 2019 and based in Montreal, MY01 envisions a world where every disease is quantifiable, enabling precise, personalized care for all patients. Specializing in managing limb ischemia and compartment syndrome, our tools provide proactive monitoring and actionable insights through a connected care team that benefits...

  • Contract Regulatory Manager

    1 week ago

    Canada, CA RBW Consulting Full time

    RBW Consulting are seeking a Regulatory Manager in Canada on a contract basis for an upcoming Phase III Dermatology study with a small European based CRO.FTE will fluctuate between 0.2-0.4 dependent on the stage of the study.Extensive regulatory background on Canadian trials is essential.Apply to find out more!

  • Regulatory Developer

    4 days ago

    Canada, CA Luxoft Full time

    Project Description:The Java Developer works under minimal supervision to design, test, and implement Java-based web applications, using industry standard software development practices, techniques, tools, and frameworks. The incumbent will be expected to design and develop complex business components in Java, deploying to Java EE Application...

  • Regulatory Compliance Specialist

    3 months ago

    Canada, CA NOW Health Group CanadaPuresource Natural Products Distributor Full time

    Scope for the position:Evaluation of new and existing product compliance for sale in the Canadian market based on current regulatory requirements for Natural Health Products (NHPs), Foods, Cosmetics, Consumer Products, and Medical Devices.Completion of product and site license compliance review and submissions under Health Canada’s applicable regulations...

  • Senior Integration Program Manager

    4 days ago

    Canada, CA Apex Systems Full time

    Job Title: Senior Integration Program ManagerRole Overview: Apex Systems is working with their technology client to oversee the end-to-end integration of their IT systems into a new infrastructure. The Integration Program Manager will ensure the seamless alignment of IT workstreams, including enterprise applications, infrastructure, data & reporting, and...

  • Senior Program Manager

    4 days ago

    Canada, CA RBC Borealis Full time

    What's the opportunity?RBC Borealis is at the forefront of artificial intelligence research and development, driving the innovative edge for the Royal Bank of Canada (RBC). Our team is dedicated to advancing the science of AI and delivering cutting-edge solutions that create substantial value for RBC and its customers. As part of RBC, you will have the...

  • Product Manager

    1 month ago

    Canada, CA CrimsonLogic Pte Ltd Full time

    Our Employee Value PropositionAdvancing our People.Advancing our World.At CrimsonLogic, we put your Career and Well-being first.We are committed to advancing your career through a full spectrum of professional Development programs with the support of a strong Total Rewards philosophy that focus on your well-being.We believe that by investing in each and...

  • Emergency Response

    4 days ago

    Canada, CA Adecco Full time

    Adecco is currently hiring a detail-oriented Emergency Response Coordinator/ H&S Administrator to join our client’s leading Oil & natural gas company in Calgary, AB.We are looking for someone with 3 to 5 years of Emergency Management Administrative experience or experience in management system documentation, and technical writing along with understanding...

  • Permitting Coordinator

    4 days ago

    Canada, CA NexGen Energy Ltd. Full time

    ROLE OVERVIEWThis position will be responsible for compiling technical information to support applications for regulatory authorizations required to advance construction of the Rook I Project (“Project”). The role involves close collaboration with a diverse range of Project team members including, but not limited to, engineering, procurement, and...

  • HQSE Specialist and Lead

    3 months ago

    Canada, CA McKeil Marine Limited Full time

    McKeil Marine is one of Canada’s leading marine service providers. Experienced and adaptive, we deliver turn-key solutions that support our customers success in a wide range of transportation and project challenges. Customer service, safety, quality, and respect for the environment are at the heart of our operations. When you join McKeil Marine you can...

  • Senior Product Manager

    1 month ago

    Canada, CA Staffing Lab LLC Full time

    Staffing Lab represents a client that has asked us to assist in identifying a candidate for a Full Time Senior Product Manager for an opening within their organization. Base up to 120k CAD plus year end 10% bonus. Must be open to travel up to 10% including international.As a Senior Product Manager you will play a critical role in defining, developing, and...

  • Environmental Health Safety Specialist

    3 months ago

    Canada, CA ML6 Search + Talent Advisory Full time

    The Opportunity:Our client, a leading manufacturing facility in the Industry & Water segment is seeking a Health, Safety & Compliance Specialist to join their team. This role will be instrumental in ensuring regulatory compliance, safety, and quality standards across operations at their South Shore (QC) Plant. The facility plays a crucial role in water...

  • Senior Drug Development Director

    1 month ago

    Canada, CA ICON Strategic Solutions Full time

    As a Senior Drug Development Director you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The Senior Drug Development Director is responsible for overseeing and coordinating the comprehensive plans and progress of all involved teams working on the asset, from pre-clinical stages...

  • Senior Manager

    4 days ago

    Canada, CA Henderson Drake Full time

    Our client, a global leader in automotive technology and manufacturing, is driving innovation across the mobility sector. Focused on employee development and pioneering technologies, the company provides a collaborative environment where finance leaders can drive impactful change. As a key player in transforming the automotive industry, the company empowers...

  • Biovia ELN System Administrator

    4 days ago

    Canada, CA I.T. Solutions, Inc. Full time

    Role: Biovia ELN System AdministratorLocation: NEAR SHORE - South America/CanadaLength: Long term rolling contract Job Description:The BIOVIA ELN (Electronic Laboratory Notebook) System Administrator is responsible for managing, maintaining, and supporting the BIOVIA ELN platform within laboratory environments. Primarily working in regulated industries like...

  • Incident Management Specialist

    4 days ago

    Canada, CA Bay Street Staffing Full time

    Consultant, Incident Management Toronto, ON (hybrid)12 monthsWhat you’ll be doingAs an Incident Management Consultant you will manage a centralized mailbox, ensuring timely and efficient communication regarding incident reports. The consultant will work closely with both internal teams and external stakeholders to identify, investigate, and mediate...

  • ValGenesis Validation Engineer

    4 days ago

    Canada, CA I.T. Solutions, Inc. Full time

    Role: ValGenesis Validation EngineerLocation: NEAR SHORE - Brazil/Puerto Rico/CanadaLength: Long-term rolling contractJob Description:The ValGenesis Validation Engineer is responsible for implementing and validating the ValGenesis Validation Lifecycle Management System (VLMS) in regulated environments, primarily within pharmaceutical, biotechnology, and...

  • Trade Compliance

    3 days ago

    Canada, CA TCWGlobal Full time

    Trade Compliance – Cross BorderFully Remote$50-$55 CAD/hrLocation: CanadaStart Date: 10/28/24End Date: 10/26/25Our leading SaaS client is looking for a Trade Compliance-Cross Border worker to be responsible for the development of international content to support the company’s Trade Compliance tools which provide compliance requirements for assisting...

  • Reporting Developer

    1 month ago

    Canada, CA Luxoft Full time

    Hybrid work (3 days from office)Project Description:The Java Developer works under minimal supervision to design, test, and implement Java-based web applications, using industry standard software development practices, techniques, tools, and frameworks. The incumbent will be expected to design and develop complex business components in Java, deploying to...

Regulatory Affairs Program Manager

3 months ago

Canada, CA Philips International Full time
Regulatory Affairs Program Manager

The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips’ Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes.

Your role:

  • Provides Regulatory Technical Competency (tactical and strategic) to the Ambulatory Monitoring & Diagnostics (AM&D) business group, including providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams and preparing comprehensive regulatory strategies for new devices and significant post market changes.
  • Create detailed written regulatory plans that can be used to support international regulatory submissions and global product sales.
  • Develop and prepare product registration submissions for the US, Canada, EU, and support submission preparation for all regulated markets.
  • Review and approve advertising, promotional items and labeling for regulatory compliance.
  • Perform regulatory impact and regulatory compliance evaluations to support engineering changes and post market activities.
  • Identify potential regulatory approvals' risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • Keep abreast of current regulatory standards, procedures, and changes.
  • Following Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP and all other applicable regulations and drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.
  • Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
  • Reporting to the Head of Regulatory Affairs for AM&D, you will communicate with Internal Stakeholders and collaborate with worldwide colleagues regarding license renewals and updates.
  • This Hybrid role may require travel up to 10%.
  • Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to one of the locations listed in the job posting.

You're the right fit if:

  • You have a minimum of 7 years’ experience in FDA Regulated Medical Device/HealthTech environments, with a focus on the preparation and submission of 510K’s, PMA’s and experience with EU MDR/MDD, Health Canada, China, etc.
  • You have a strong background in Design Controls.
  • You have detailed knowledge of medical device regulations (21CFR), FDA law, MDD/MDR, other global laws, regulations and standards including ISO 14971, IEC 60601-1, and related particular standards.
  • You’re experienced in supporting international registrations and/or clinical investigations.
  • You have a proven understanding of LEAN concepts, methodologies, and deployment.
  • You’re proficient in Microsoft Office.
  • You have a minimum of a Bachelor’s degree (REQUIRED), preferably in Regulatory Affairs and/or a science or engineering related field. Master’s/PhD desired.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
  • 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.

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.

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.

Philips Transparency Details:

The pay range for this position is $104,000 to $178,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

#LI-PH1

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.

#J-18808-Ljbffr