Sr. Regulatory Affairs Specialist

24 Apr, 2022

Jobs

Sr. Regulatory Affairs Specialist

Phillips
Orlando, FL

Job Title

Sr. Regulatory Affairs Specialist

Job Description

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*.  Employees may request a reasonable accommodation.*Montana employees are currently excluded from this requirement at this time.

 

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.  You may contact 888-367-7223, option 5, for assistance.

 

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

 

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

 

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

 

In this role, you have the opportunity to make life better

 

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

 

Formulate the medium term regulatory policy into a regulatory strategic plan, while also being involved in developing, modifying and executing company regulatory strategies and policies that affect immediate operations.

 

You are responsible for

  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
  • Create detailed written regulatory plans that will be used to target domestic and international shipment dates.
  • Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
  • Review and approve advertising, promotional items and labeling for regulatory compliance.
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • Communicate application progress to internal stakeholders
  • Collaborate with worldwide colleagues regarding license renewals and updates
  • Maintain regulatory files and tracking databases as required
  • Communicate with regulatory agencies as needed
  • Mentor other regulatory affairs personnel within GSC

 

 

You are part of

 

Consists of members of the Regulatory Affairs Team and directly reports to Krystal Mitchell.

 

To succeed in this role, you’ll need a customer-first attitude and the following

 

  • Bachelor’s degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
  • 5 + years of regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.)
  • Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
  • Proficient knowledge of domestic and international standards
  • Experience with FDA 510(k) submissions
  • RAPs RAC strongly preferred
  • Understand LEAN concepts, methodologies and deployment
  • May require 10% travel annually with possibly some international

 

In return, we offer you

 

Our benefits can be found here:  https://www.careers.philips.com/na/en/total-rewards-at-philips

 

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

 

Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.

 

#LI-Remote

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

 

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.
Equal Opportunity Employer/Disabled/Veteran

Learn more here

Job posted: 2022-04-24