Regulatory Affairs Program Manager

1 month ago

San Diego, California, United States Philips Full time

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 , 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 ,-cognitive-and-environmental-pce-job-requirements) .
  • 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.

  • Learn more about our business ) .
  • Discover our rich and exciting history. )
  • Learn more about our purpose. )
  • Read more about our employee benefits ) .

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

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact , option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran


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