Philips

Regulatory Program Manager

Philips

Plymouth, MN, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to the exciting world of regulatory affairs at Philips! We are seeking a highly motivated and experienced Regulatory Program Manager to join our team and help drive our global regulatory strategies. As a key member of our regulatory affairs department, you will have the opportunity to lead and coordinate the development and implementation of regulatory programs to ensure compliance with applicable laws and regulations. This is a dynamic and challenging role that requires exceptional leadership skills, strong regulatory knowledge, and a passion for making a positive impact on healthcare. If you are a driven and results-oriented individual with a keen eye for detail and a dedication to quality, we encourage you to apply for this role and become part of our mission to improve lives through meaningful innovation.

  1. Develop and implement global regulatory strategies in alignment with company objectives and applicable laws and regulations.
  2. Lead and coordinate cross-functional teams to ensure timely and successful completion of regulatory programs.
  3. Conduct thorough research and analysis of regulatory requirements to ensure compliance and mitigate risks.
  4. Collaborate with internal and external stakeholders, such as regulatory agencies and industry associations, to stay updated on changes in regulations and incorporate them into company strategies.
  5. Provide guidance and support to product development teams on regulatory requirements and implications.
  6. Oversee the preparation and submission of regulatory documents, including applications, reports, and registrations.
  7. Manage and maintain all regulatory documentation and records in accordance with company and regulatory standards.
  8. Conduct audits and assessments to identify and address any compliance gaps or issues.
  9. Keep abreast of industry trends and best practices in regulatory affairs and incorporate them into company strategies.
  10. Monitor and track the progress of regulatory programs, identify any delays or roadblocks, and propose solutions to ensure timely completion.
  11. Ensure all regulatory activities are conducted with the highest level of quality and accuracy.
  12. Train and mentor junior team members to develop their regulatory knowledge and skills.
  13. Represent the company in meetings and interactions with regulatory agencies.
  14. Continuously evaluate and improve processes and procedures related to regulatory affairs.
  15. Adhere to company values and ethical standards in all aspects of the job.
Where is this job?
This job is located at Plymouth, MN, USA
Job Qualifications
  • Strong Understanding Of Regulatory Requirements: A Qualified Regulatory Program Manager At Philips Should Possess A Deep Understanding Of Local, National, And International Regulatory Requirements Related To The Medical Device Industry. This Includes Knowledge Of Fda Regulations, Iso Standards, And Other Relevant Guidelines.

  • Project Management Skills: The Role Of A Regulatory Program Manager Requires The Individual To Manage Multiple Projects Simultaneously. This Includes Planning, Organizing, And Coordinating Tasks To Ensure Timely And Successful Completion Of Regulatory Submissions And Approvals.

  • Excellent Communication Skills: Effective Communication Is Crucial In This Role As The Regulatory Program Manager Will Be Responsible For Liaising With Internal Teams, External Stakeholders, And Regulatory Agencies. This Includes Presenting Complex Regulatory Information In A Clear And Concise Manner.

  • Attention To Detail: The Medical Device Industry Is Highly Regulated, And Even The Smallest Error In Regulatory Submissions Can Have Significant Consequences. A Qualified Regulatory Program Manager Should Have A Keen Eye For Detail And Be Able To Identify Potential Discrepancies Or Issues In Regulatory Documentation.

  • Experience In The Medical Device Industry: While Not A Requirement, Previous Experience In The Medical Device Industry Can Be Beneficial For A Regulatory Program Manager. This Includes Knowledge Of The Product Development Process, Quality Management Systems, And Other Relevant Aspects Of The Industry.

Required Skills
  • Quality Assurance

  • Change Management

  • Communication Skills

  • Project Management

  • Data Analysis

  • Team Leadership

  • Risk assessment

  • Policy Development

  • Regulatory analysis

  • Stakeholder engagement

  • Compliance monitoring

  • Problem

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Time management

  • Interpersonal Skills

  • creativity

  • Critical thinking

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Regulatory Program Manager in Plymouth, MN, USA is $90,000 to $120,000 per year. This may vary depending on the specific company, the level of experience, and the specific responsibilities of the role. Some companies may offer additional benefits such as bonuses, stock options, and other incentives that could increase the overall compensation for this position.

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 BeforeJune 21st, 2025
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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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