Regulatory Operations Specialist
In this role, you have the opportunity to
As a Regulatory Operations Specialist, you will use your expertise and knowledge of regulatory requirements in developing Technical Documentation (Technical Files) compliant with the new EU MDR requirements. Additional assignments may include 510(k) submission packages for Class II medical Devices. These documentation packages represent the intended use, product design, verification and validation, clinical evaluation and manufacturing technologies of our monitoring systems.
You are responsible for
- Provide regulatory compliance guidance to drive global initiatives such as EU MDR.
- Develop and maintain technical documentation (technical files) required for regulatory compliance to EU MDR.
- Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance, Marketing and international geographies to develop a regulatory strategy for the business
- Transparent sharing current, new and changing regulatory requirements, using your expert and proper interpretation to support medical device registrations in all global markets
- Develop compliant regulatory submission packages which support successful approval or clearance to market
- Work closely with other regulatory and clinical professionals to ensure all product and clinical information is adequately and correctly represented
- Ensure Declarations of Conformity correctly represent all standards and regulatory requirements applicable to current technologies in the device
- Identify issues that need resolution to ensure continued registrations in all global markets planned for commercialization
- Participate in cross-functional meetings to provide regulatory perspective and interpretative knowledge
- Knowledge of how to, or a willingness to learn to write protocols, reports, and other documentation to support international registrations
You are a part of
Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.
Philips Patient Monitoring products are designed to help medical professionals enhance patient care and improve clinical performance. The technology which supports monitoring performance helps identify patients in need – early; supports caregivers on the go, closes the gap in patient information and efficiently delivers quality care. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.
To succeed in this role, you should have the following skills and experience
- An individual with a regulatory discipline as related to medical device products
- 5+ years of experience writing and assembling technical documentation files or design dossiers
- 3+ years of experience in international and US FDA 510(k) regulatory submissions
- Deep knowledge about new EU MDR and differences to MDD
- Experience in associated regulations relevant to labeling and use of international symbols
- Knowledge of regulatory requirements for CE marking and UDI
- RAPs RAC preferred
- Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape
- Ability to work nimbly, innovative approach to problem solving
- Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment
- Interest in and passion for the medical device industry, bringing innovation to market
- Effective working in multidisciplinary and cross-functional teams
- Good communication skills, written and verbal
- Proficient computer skills in Microsoft Office.
- May require 5% travel annually with possibly some international
In return, we offer you
This exciting opportunity is supporting Philips’ transition into the EU MDR regulated environment. The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It is to better identify medical device products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). Similar to the FDA’s UDI, EU MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation.
You will have exposure to a multitude of indications, medical devices, and workflow solutions. This position works in partnership with R&D, marketing, regulatory, quality, and legal among other functional areas where you will guide team members in application of all applicable regulatory requirements; ensuring documentation is adequate for successful regulatory submissions. Your expert knowledge of the changing regulatory environment will ensure our devices are compliant to global regulations, in order to prevent business disruption in any market. You will partner with other key regulatory professionals to drive consistently good regulatory practices within Philips, contributing to seamless regulatory approvals. This matrix organization approach will improve collaboration and your learning and development across a multitude of disciplines.
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.
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.
If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. In case of technical difficulties, please send an email to email@example.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.)