Philips Regulatory Affairs Specialist, Senior in Monroeville, Pennsylvania

Sr. Regulatory Affairs Engineer

B.S. or B.A in engineering or science discipline or equivalent. Certifications preferred.

5 - 7 Years Experience. Duties and tasks reflect variety and complexity.

Work independently on Regulatory Affairs duties, processes and roles outlined below:

  • Supports and provides regulatory expertise to assigned medical device product development projects from initial kickoff to post marketing phase. Primary focus is supporting Sleep therapy and Diagnostic device types.

  • Creation and execution of Regulatory Strategies and Plans for assigned medical device products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.

  • Develops the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released.

  • Prepares and submits US FDA pre-sub, 510(k), and other product submissions according to FDA guidelines.

  • Creates EU Technical File and Declaration of Conformity documents (MDD, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines.

  • Maintains expertise in domestic and international regulations and standards, with a focus on assigned medical devices and regional focus on the US (FDA), EU (MDD), and CA (Health Canada).

  • Support the international regulatory specialist team with inputs, as needed, into the registration packages they prepare.

  • Supports pending domestic and international regulatory changes and executes quality plans to minimize impact

  • Provides the Regulatory assessment of Engineering Changes for medical device launch and sustaining activities

  • Supports tender offer requests and reimbursement submissions needs

  • Creates and/or lifts Regulatory Restrictions based on the Regulatory status of assigned medical devices

  • Reviews and approves medical device labeling plans, instructions for use, labels, and marketing communications

  • Supports Internal and External Quality Audits Supports Regulatory QMS procedure updates

  • Provides Regulatory training to project teams on domestic and international regulations

  • Supports Clinical Research with protocol development, reviews and submissions, including FDA Investigational Device Exemption (IDE) applications, EU Competent Authority applications and Health Canada Investigational Testing Authorizations (ITA).

In this role, you have the opportunity to

Regulatory Affairs Support for New Product Development and Sustaining efforts in both the domestic and international markets for assigned medical devices. Provide direct project support for registration and licensing in the US, Canada and EU and indirect support to the International Market groups for all other licensing.

You are responsible for

  • Identify areas for improvement for efficiency and compliance in the internal processes, work instructions, and forms and apply technical expertise to process improvement efforts.

  • May lead or participate on process improvement teams to affect changes at a local or cross business unit level.

  • Maintain technical expertise in core job functions including all applicable QSPs, WI, Forms, Philips training, and regulatory body requirements.

  • Maintain expertise in the interpretation of domestic and international regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned medical devices, with a special focus on mature markets: USA, Canada, and EU.

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

  • Supports and provides regulatory expertise to assigned medical device product development projects from initial kickoff to post marketing phase.

  • Creation and execution of Regulatory Strategies and Plans for assigned medical device products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.

  • Develops the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released.

  • Prepares and submits US FDA pre-sub, 510(k), and other product submissions according to FDA guidelines.

  • Creates EU Technical File and Declaration of Conformity documents (MDD, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines.

  • Maintains expertise in domestic and international regulations and standards, with a focus on assigned medical devices and regional focus on the US (FDA), EU (MDD), and CA (Health Canada).

  • Support the international regulatory specialist team with inputs, as needed, into the registration packages they prepare.

  • Supports pending domestic and international regulatory changes and executes quality plans to minimize impact

  • Provides the Regulatory assessment of Engineering Changes for medical device launch and sustaining activities

  • Reviews and approves medical device labeling plans, instructions for use, labels, and marketing communications

  • Supports Internal and External Quality Audits Supports Regulatory QMS procedure updates

  • B.S. or B.A in engineering or science discipline or equivalent. Certifications preferred.

  • 5 + years’ experience

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.