Regulatory Affairs Specialist

Philips Monroeville , PA 15146

Posted 1 week ago

Job Title

Regulatory Affairs Specialist

Job Description

In this role, you have the opportunity to

Provide regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.

You are responsible for

Working independently on the Regulatory duties, processes and roles outlined below:

  • Acts as liaison between multiple project teams and in-country/regional Regulatory Affairs teams. In-country/Regional Regulatory Affairs teams may involve Philips associates and/or external customers.

  • Gathers registration deliverables to support product registrations and acts as conduit for Q&A that may originate from business unit project team, in-country/regional Regulatory Affairs team, or governing regulatory body (as communicated by in-country team).

  • Routinely tracks registration status in central database for input into both project team and senior management discussions.

  • Responsible for communicating design changes and introducing new products to in-country/regional Regulatory Affairs teams. May involve leading routine calls with Marketing and Regulatory leadership to discuss registration status and priorities.

  • Participates in training of business unit associates, both inside and outside of Regulatory Affairs, on country requirements

  • May involve acting as lead for implementation of new country regulations and requirements. This can include process updates and training.

  • Works to understand regulatory requirements of countries

Your Team

At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.

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.

Our Offer

Here at Philips WE ARE Working Together for a Better Tomorrow

Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.

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

B.S. or equivalent in Engineering, Life sciences, or other similar technical field. RAC preferred. Unique combinations of education and experience may be substituted if they provide the essential skill sets for the position.

The successful candidate will have:

  • Knowledge in the area of FDA procedures and practices, a working knowledge of medical device regulations, and experience in the medical device industry.

  • Working knowledge of company products and services.

  • Ability to collaborate with and influence others.

  • 1+ year of experience in the medical device industry or a regulated industry.

  • Familiar with regulatory documents

  • Experience in supporting international registrations

Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That's okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA.

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.

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If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to careersite@philips.com.

(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)


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Regulatory Affairs Specialist

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