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Lead Regulatory Affairs Consultant

3 months ago

Canada Philips International Full time $77,000 - $136,000
Position Overview

As a Lead Regulatory Affairs Consultant at Philips International, you will play a pivotal role in shaping the future of healthcare technology. Your commitment to enhancing lives will drive you to develop and implement effective regulatory strategies that align with our mission of providing quality healthcare for all.

Key Responsibilities
  • Regulatory Strategy Development: Formulate and execute comprehensive regulatory strategies for both innovative and existing medical devices, ensuring compliance with global standards.
  • Communication: Clearly articulate regulatory strategies to management, cross-functional teams, and leadership, facilitating informed decision-making regarding device modifications.
  • Submissions and Filings: Prepare and oversee product registration submissions for various regions, including the US, Canada, and the EU, while supporting international submissions as required.
  • Compliance Review: Evaluate and authorize promotional materials and labeling to ensure adherence to regulatory requirements.
  • Risk Assessment: Identify potential regulatory risks stemming from changes in legislation, standards, or project-specific factors.
  • Collaboration: Work closely with global colleagues on license renewals and updates, fostering a cooperative regulatory environment.
  • Agency Interaction: Engage with regulatory bodies as necessary to facilitate compliance and approvals.
  • Audit Support: Assist in site audits related to responsible products, including various regulatory inspections and audits.
  • Post-Market Support: Provide regulatory support for audits, corrective actions, and post-market activities as assigned.
Qualifications

The ideal candidate will possess a Bachelor's or Master's degree in Regulatory Affairs or a related scientific discipline, along with a minimum of 5 years of experience in regulatory submissions and approvals, including EU MDR and Health Canada regulations.

Company Mission

At Philips International, we are dedicated to the belief that every individual matters. Our goal is to ensure that everyone has access to the quality healthcare they deserve. Join us in making a meaningful impact in the lives of others.

We encourage candidates with diverse experiences to consider this opportunity, as we value a range of perspectives and backgrounds.