Senior Manager of Regulatory Affairs Programs

1 week ago

Canada Philips International Full time $104,000 - $178,000
Senior Manager of Regulatory Affairs Programs

The Senior Manager of Regulatory Affairs Programs will be pivotal in ensuring compliance for Philips' Ambulatory Monitoring & Diagnostics (AM&D) products by formulating thorough global regulatory strategies for new devices and significant post-market modifications.

Key Responsibilities:

  • Deliver Regulatory Technical Expertise (both tactical and strategic) to the Ambulatory Monitoring & Diagnostics (AM&D) division, providing precise and consistent regulatory guidance, decisions, and insights to product development and manufacturing teams while crafting comprehensive regulatory strategies for new devices and substantial post-market alterations.
  • Develop detailed written regulatory plans to support international regulatory submissions and facilitate global product sales.
  • Prepare and develop product registration submissions for the US, Canada, EU, and assist in submission preparation for all regulated markets.
  • Evaluate and approve advertising, promotional materials, and labeling for regulatory adherence.
  • Conduct regulatory impact assessments and compliance evaluations to support engineering modifications and post-market activities.
  • Identify potential risks associated with regulatory approvals based on changes in regulations, standards, country-specific issues, or other unique project characteristics.
  • Stay updated on current regulatory standards, procedures, and changes.
  • Adhere to Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and all other relevant regulations, driving enhancements in regulatory aspects of the Quality System, developing processes, and documenting procedures to ensure an effective Quality System.
  • Review and suggest modifications for design processes and manufacturing procedures to uphold quality and regulatory compliance.
  • Reporting to the Head of Regulatory Affairs for AM&D, you will engage with Internal Stakeholders and collaborate with global colleagues regarding license renewals and updates.
  • This Hybrid role may necessitate travel up to 10%.
  • Company relocation benefits will not be provided for this position. Candidates must reside in or within commuting distance to one of the locations listed in the job posting.

Ideal Candidate Profile:

  • A minimum of 7 years' experience in FDA Regulated Medical Device/HealthTech environments, focusing on the preparation and submission of 510K's, PMA's, and familiarity with EU MDR/MDD, Health Canada, China, etc.
  • Strong background in Design Controls.
  • In-depth knowledge of medical device regulations (21CFR), FDA law, MDD/MDR, and other global laws, regulations, and standards including ISO 14971, IEC, and related specific standards.
  • Experience in supporting international registrations and/or clinical investigations.
  • Proven understanding of LEAN concepts, methodologies, and deployment.
  • Proficient in Microsoft Office.
  • A minimum of a Bachelor's degree (REQUIRED), preferably in Regulatory Affairs and/or a science or engineering-related field. A Master's/PhD is desirable.
  • Ability to successfully perform the following minimum Physical, Cognitive, and Environmental job requirements with or without accommodation for this position.
  • US work authorization is a prerequisite for 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 organization dedicated to the belief that every individual matters, and we strive until everyone everywhere has access to the quality healthcare they deserve. Contribute to meaningful work that enhances the lives of others.

If you find this role appealing and possess many, but not all, of the required experiences, 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.

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