Philips Regulatory Affairs Associate in Stamford, Connecticut

QMS- 40%

  • Assists in developing procedures to ensure regulatory compliance.

  • Assists with creating, maintaining and controlling regulatory compliance records.

  • Supports the implementation of corrective actions and preventive actions aimed to ensure compliance pertaining to regulatory requirements.

  • Assists the Regulatory Affairs Manager and Quality System manager in establishing programs and processes for improving regulatory and quality KPI’s.

Regulatory- 40%

  • As required, files registrations, licenses and reports with governmental agencies, including, but not limited, to US FDA MDR’s, EPA annual pesticide reports and US pesticide device registrations.

• Supports information gathering for issuing Certificate of Conformance pertaining to Children’s Products.

Customer- 20%

  • Acts as the center point of contact for managing the retailer complaints database.

  • Assist in providing regulatory data to customers’ regulatory repositories/databases.

In this role, you have the opportunity to

The Regulatory Affairs Associate will provide the Philips North America market support in complying with regulatory, customer and QMS (Quality Management Systems) requirements applicable to consumer products.

You are responsible for

The Regulatory Affairs Associate will provide the Philips North America market support in complying with regulatory, customer and QMS (Quality Management Systems) requirements applicable to consumer products. A clinical research associate monitors the clinical study and ensures that investigators follow the clinical trial protocol at all times to obtain high quality integrity data.

QMS- 40%

  • Assists in developing procedures to ensure regulatory compliance.

  • Assists with creating, maintaining and controlling regulatory compliance records.

  • Supports the implementation of corrective actions and preventive actions aimed to ensure compliance pertaining to regulatory requirements.

  • Assists the Regulatory Affairs Manager and Quality System manager in establishing programs and processes for improving regulatory and quality KPI’s.

Regulatory- 40%

  • As required, files registrations, licenses and reports with governmental agencies. These include, but are not limited, to US FDA MDR’s, EPA annual pesticide reports and US States pesticide device registrations.

• Supports information gathering for issuing Certificates of Conformance pertaining to Children’s Products.

Customer- 20%

  • Acts as the center point of contact for managing the retailer complaints database.

  • Assists in providing regulatory data to customers’ regulatory repositories/databases.

You are a part of

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.

To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree with 1+ years of experience. Consumer product experience is preferred.

  • Flexible, with the ability to multi-task.

  • Excellent oral and written communication skills.

  • Ability to work independently as well as in a team environment.

  • Excellent attention to detail.

In return, we offer you

Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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 888-367-7223, option 5, for assistance.