Philips

Regulatory Program Manager

Philips

San Diego, CA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Dear potential candidates,We are seeking a highly motivated and experienced Regulatory Program Manager to join our dynamic team at Philips. As a global leader in health technology, we are dedicated to improving lives through innovative and sustainable solutions. In this role, you will have the opportunity to work on impactful projects that directly contribute to our mission of making the world a healthier and more sustainable place.We are looking for a driven individual with a strong background in regulatory affairs and program management. The ideal candidate will have a proven track record of successfully navigating complex regulatory environments and driving projects to completion. Additionally, we are seeking someone who is passionate about staying up-to-date on industry regulations and trends, and has excellent communication and leadership skills.If you are ready to take on a challenging and fulfilling role with a company that is making a difference in the world, we encourage you to apply for the position of Regulatory Program Manager at Philips.

  1. Develop and implement regulatory strategies to ensure compliance with global regulations and standards.
  2. Serve as the primary point of contact for all regulatory matters related to assigned projects.
  3. Coordinate with cross-functional teams to ensure timely and successful submission of regulatory documents.
  4. Stay up-to-date on regulatory changes and trends to inform decision-making and ensure compliance.
  5. Create and maintain project plans, timelines, and budgets to ensure timely completion of projects.
  6. Lead and facilitate meetings with internal stakeholders and regulatory agencies.
  7. Provide guidance and support to project teams on regulatory requirements and processes.
  8. Establish and maintain relationships with regulatory agencies and key stakeholders.
  9. Review and approve labeling, advertising, and promotional materials for compliance with regulations.
  10. Manage and maintain all regulatory documentation and records.
  11. Conduct risk assessments and develop mitigation strategies to address potential regulatory issues.
  12. Prepare and submit regulatory submissions, including premarket notifications, marketing applications, and annual reports.
  13. Develop and implement training programs to ensure company-wide understanding of regulatory requirements.
  14. Monitor and report on the status of regulatory submissions and approvals.
  15. Collaborate with internal teams to identify and implement process improvements to increase efficiency and compliance.
  16. Participate in product development and design control activities to ensure regulatory requirements are met.
  17. Act as a subject matter expert on regulatory affairs and provide guidance to cross-functional teams.
  18. Represent the company at industry conferences and events to stay informed on regulatory trends and best practices.
  19. Manage and mentor a team of regulatory professionals.
  20. Continuously assess and improve regulatory processes and procedures to ensure compliance and efficiency.
Where is this job?
This job is located at San Diego, CA, USA
Job Qualifications
  • Bachelor's Or Master's Degree In A Relevant Field Such As Regulatory Affairs, Healthcare Management, Or Business Administration.

  • Minimum Of 5 Years Of Experience In Regulatory Affairs Or Related Field, Preferably In The Medical Device Industry.

  • Strong Knowledge Of Global Regulatory Requirements And Standards, Including Fda, Eu Mdr, And Iso.

  • Excellent Project Management Skills, With The Ability To Manage Multiple Projects And Deadlines Simultaneously.

  • Experience In Managing Cross-Functional Teams And Working Collaboratively With Internal And External Stakeholders.

Required Skills
  • Quality Assurance

  • Communication Skills

  • Project Management

  • Data Analysis

  • Compliance Management

  • Risk assessment

  • Problem-Solving

  • Cross-Functional Team Leadership

  • Policy Development

  • Stakeholder engagement

  • Regulatory Affairs

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Problem Solving

  • Time management

  • creativity

  • Critical thinking

  • Teamwork

  • Adaptability

  • Empathy

Compensation

According to JobzMall, the average salary range for a Regulatory Program Manager in San Diego, CA, USA is between $110,000-$140,000 per year. This can vary depending on the specific company, years of experience, and level of education.

Additional Information
Philips is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedJanuary 19th, 2024
Apply BeforeMay 10th, 2026
This job posting is from a verified source. 
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About Philips

Royal Philips is a health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.

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