Current jobs related to Regulatory Affairs Program Manager - Canada - Philips International
-
Regulatory Affairs Specialist
2 months ago
Canada Organon LLC Full timeRegulatory Affairs Specialist **Job Summary** Organon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Chemistry, Manufacturing & Controls (CMC) department, you will be responsible for providing regulatory CMC support for our Network Projects. **Key Responsibilities** * Lead the preparation and...
-
Regulatory Affairs Specialist
2 months ago
Canada Organon LLC Full timeRegulatory Affairs Specialist **Job Summary** Organon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Chemistry, Manufacturing & Controls (CMC) department, you will be responsible for providing regulatory CMC support for our Network Projects. **Key Responsibilities** * Lead the preparation and...
-
Regulatory Affairs Specialist
2 months ago
Canada Organon LLC Full timeJob SummaryOrganon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for assigned Network Projects.Provide regulatory CMC...
-
Regulatory Affairs Specialist
2 months ago
Canada Organon LLC Full timeJob SummaryOrganon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for assigned Network Projects.Provide regulatory CMC...
-
Regulatory Affairs Specialist
2 months ago
Canada Organon LLC Full timeOrganon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Chemistry, Manufacturing & Controls (CMC) department, you will be responsible for providing regulatory CMC support for our Network Projects. Your expertise will be crucial in leading the preparation and submission of CMC dossiers for assigned...
-
Regulatory Affairs Specialist
2 months ago
Canada Organon LLC Full timeOrganon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Chemistry, Manufacturing & Controls (CMC) department, you will be responsible for providing regulatory CMC support for our Network Projects. Your expertise will be crucial in leading the preparation and submission of CMC dossiers for assigned...
-
Senior Manager, Regulatory Affairs Lead
3 weeks ago
Canada Bluebayinvest Full timeJob SummaryBluebayinvest is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our IT Risk Management function, you will play a critical role in protecting our brand, systems, and operations by equipping business and technology partners with meaningful insights, advice, and information on RBC IT & cyber risks.Key...
-
Senior Regulatory Affairs Specialist
1 month ago
Canada Organon LLC Full timeJob SummaryWe are seeking a highly skilled Associate Principal Scientist, Regulatory Affairs to join our team at Organon LLC. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory CMC support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for assigned Network...
-
Senior Regulatory Affairs Specialist
1 month ago
Canada Organon LLC Full timeJob SummaryWe are seeking a highly skilled and experienced Associate Principal Scientist, Regulatory Affairs to join our team at Organon LLC. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory CMC support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for...
-
Senior Regulatory Affairs Specialist
1 month ago
Canada Organon LLC Full timeJob SummaryWe are seeking a highly skilled Associate Principal Scientist, Regulatory Affairs to join our team at Organon LLC. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory CMC support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for assigned Network...
-
Senior Regulatory Affairs Specialist
1 month ago
Canada Organon LLC Full timeJob SummaryWe are seeking a highly skilled and experienced Associate Principal Scientist, Regulatory Affairs to join our team at Organon LLC. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory CMC support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for...
-
Regulatory Consultant Manager
1 month ago
Canada CKOC 1150 Radio Inc Full timeJob Title: Manager, Regulatory ConsultingAbout the Role:We are seeking a highly skilled and experienced Manager, Regulatory Consulting to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and support to our clients in the development and implementation of regulatory strategies.Key...
-
Regulatory Consultant Manager
1 month ago
Canada CKOC 1150 Radio Inc Full timeJob Title: Manager, Regulatory ConsultingAbout the Role:We are seeking a highly skilled and experienced Manager, Regulatory Consulting to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and support to our clients in the development and implementation of regulatory strategies.Key...
-
Regulatory Affairs Specialist
3 weeks ago
Canada Organon LLC Full timeJob Title: Associate Principal Scientist, Regulatory AffairsThe Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide strategic CMC support for Organon Network Projects. This position will lead the preparation and submission of...
-
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...
-
Canada Organon LLC Full timeAssociate Principal Scientist, Regulatory Affairs Chemistry ManufacturingAbout the RoleWe are seeking an experienced Associate Principal Scientist to join our Regulatory Affairs Chemistry Manufacturing team. As a key member of our team, you will be responsible for providing regulatory support for our Network Projects, including the preparation and submission...
-
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...
-
Associate Director, Regulatory Affairs
1 month ago
Canada GlaxoSmithKline Full timeJoin Our Team as an Associate Director, RegulatoryWe are seeking a highly skilled Associate Director, Regulatory to join our Epidemiology Department at GlaxoSmithKline. As a key member of our team, you will provide scientific leadership in the application of epidemiological expertise and methods to drive Epidemiology strategy and studies across the spectrum...
-
Associate Director, Regulatory Affairs
1 month ago
Canada GlaxoSmithKline Full timeJoin Our Team as an Associate Director, RegulatoryWe are seeking a highly skilled Associate Director, Regulatory to join our Epidemiology Department at GlaxoSmithKline. As a key member of our team, you will provide scientific leadership in the application of epidemiological expertise and methods to drive Epidemiology strategy and studies across the spectrum...
-
Senior Regulatory Affairs Specialist
1 month ago
Canada Organon LLC Full timeJob Title: Associate Director, Regulatory CMCOrganon LLC is seeking an experienced Associate Director to lead our Regulatory CMC team. As a key member of our organization, you will be responsible for providing regulatory CMC support for our network projects.Key Responsibilities:Lead the preparation and submission of CMC dossiers for assigned network...
Regulatory Affairs Program Manager
2 months ago
We are seeking a highly skilled Regulatory Affairs Program Manager to join our team at Philips International. As a key member of our Ambulatory Monitoring & Diagnostics (AM&D) business group, you will play a critical role in ensuring our products are compliant with regulatory requirements.
Key Responsibilities- Regulatory Strategy and Compliance
- Develop and implement comprehensive global regulatory strategies for new devices and significant post-market changes.
- Provide accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
- Regulatory Planning and Submissions
- Create detailed written regulatory plans 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.
- Regulatory Compliance and Risk Management
- 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.
- Regulatory Knowledge and Expertise
- Stay up-to-date with current regulatory standards, procedures, and changes.
- Develop and maintain expertise in medical device regulations (21 CFR), FDA law, MDD/MDR, other global laws, regulations, and standards, including ISO 14971, IEC, and related particular standards.
- Collaboration and Communication
- Collaborate with worldwide colleagues regarding license renewals and updates.
- Communicate effectively with internal stakeholders, including product development and manufacturing teams.
- Experience
- Minimum of 7 years' experience in FDA-regulated medical device/health tech environments, with a focus on the preparation and submission of 510Ks, PMAs, and experience with EU MDR/MDD, Health Canada, China, etc.
- Education
- Minimum of a Bachelor's degree (required), preferably in Regulatory Affairs and/or a science or engineering-related field. Master's/PhD desired.
- Skills
- Strong background in Design Controls.
- Proven understanding of LEAN concepts, methodologies, and deployment.
- Proficient in Microsoft Office.
- Physical, Cognitive, and Environmental Job Requirements
- Ability to perform the minimum physical, cognitive, and environmental job requirements with or without accommodation for this position.
- Work Authorization
- 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.
We are a health technology company committed to improving the lives of others. Our mission is to provide quality healthcare solutions that make a meaningful difference in people's lives. If you're passionate about regulatory affairs and compliance, and want to join a dynamic team that shares your values, we encourage you to apply.
