Philips Senior Regulatory Affairs Specialist in United States of America - Home Based, Massachusetts

As Senior Regulatory Affairs Specialist

You are responsible for

  • Critical team leader, thought leader, regulatory SME, and strategist.

  • Plans, leads, tracks and executes global regulatory submissions strategies for global markets for new and sustaining product lines.

  • Plans, reviews, tracks, approves all forms of labelling, procedures, ad & promo, and all required forms of documentation applied to medical devices.

  • Represents the BG (Business Group) on internal Philips and on external regulatory related committees.

  • Provides leadership and training to BG personnel on understanding, interpretation and implementation of standards and regulations.

  • Works closely as key team member along with R&D, Quality, Regulatory, Medical, Marketing, and Clinical on all aspects of product life cycle.

  • Plans, reviews, tracks, executes, approves all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments

  • Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways

  • Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in relevant business process/function

  • Viewed as an expert in the field

  • May have a leadership role

  • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.

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

  • Working knowledge of appropriate global medical device regulations, requirements, and standards.

  • 7+ years of experience.

  • Bachelor’s d You are responsible for

  • Critical team leader, thought leader, regulatory SME, and strategist.

  • Plans, leads, tracks and executes global regulatory submissions strategies for global markets for new and sustaining product lines.

  • Plans, reviews, tracks, approves all forms of labelling, procedures, ad & promo, and all required forms of documentation applied to medical devices.

  • Represents the BG (Business Group) on internal Philips and on external regulatory related committees.

  • Provides leadership and training to BG personnel on understanding, interpretation and implementation of standards and regulations.

  • Works closely as key team member along with R&D, Quality, Regulatory, Medical, Marketing, and Clinical on all aspects of product life cycle.

  • Plans, reviews, tracks, executes, approves all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments

  • Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways

  • Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in relevant business process/function

  • Viewed as an expert in the field

  • May have a leadership role

  • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.

  • 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

  • Working knowledge of appropriate global medical device regulations, requirements, and standards.

  • 7+ years of experience.

  • Bachelor’s degree in science or engineering required.

  • Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs) desired

  • egree in science or engineering required.

  • Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs) desired

In this role, you have the opportunity to:

You will be a critical team member, regulatory SME, and strategist. You will build regulatory capabilities to support Emerging Businesses to developing regulatory strategy for successful approval / clearance in US market.

You are responsible for

  • Critical team leader, thought leader, regulatory SME, and strategist.

  • Plans, leads, tracks and executes global regulatory submissions strategies for global markets for new and sustaining product lines.

  • Plans, reviews, tracks, approves all forms of labelling, procedures, ad & promo, and all required forms of documentation applied to medical devices.

  • Represents the BG (Business Group) on internal Philips and on external regulatory related committees.

  • Provides leadership and training to BG personnel on understanding, interpretation and implementation of standards and regulations.

  • Works closely as key team member along with R&D, Quality, Regulatory, Medical, Marketing, and Clinical on all aspects of product life cycle.

  • Plans, reviews, tracks, executes, approves all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments

  • Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways

  • Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in relevant business process/function

  • Viewed as an expert in the field

  • May have a leadership role

  • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.

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

  • Working knowledge of appropriate global medical device regulations, requirements, and standards.

  • 7+ years of experience.

  • Bachelor’s degree in science or engineering required.

  • Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs) desired

  • Travel about 50%

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.