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Senior Regulatory Affairs Specialist

2 months ago

Canada Philips International Full time
Job Summary

We are seeking a highly experienced 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 global 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 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 Affairs and Quality System
    • Keep abreast of current regulatory standards, procedures, and changes.
    • Follow Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and all other applicable regulations.
    • Develop processes and document procedures to ensure an effective Quality System.
  • Communication and Collaboration
    • Communicate with internal stakeholders and collaborate with worldwide colleagues regarding license renewals and updates.
Requirements
  • 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.
    • Detailed knowledge of medical device regulations (21 CFR), FDA law, MDD/MDR, other global laws, regulations, and standards, including ISO 14971, IEC, and related particular standards.
    • Experience in supporting international registrations and/or clinical investigations.
    • Proven understanding of LEAN concepts, methodologies, and deployment.
    • Proficient in Microsoft Office.
  • Physical, Cognitive, and Environmental Requirements
    • Ability to successfully 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.
About Philips International

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. We believe that every human matters, and we strive to create a workplace culture that values diversity, inclusion, and innovation.

We are an equal opportunities employer and welcome applications from qualified candidates who share our values and passion for making a difference in the world of healthcare.