Sr. Regulatory Specialist
Job Posting Description
In this role you will have the opportunity obtain domestic and international regulatory clearances, approvals, registrations and licenses for new and existing medical devices.
You are responsible for
- Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards
- Review development quality reports and plans to ensure that the information required for submissions is adequate
- Plan, generate, and coordinate regulatory submissions
- Coordinate testing required to support regulatory submissions
- Review and approve product/solution labeling and product/solution-related marketing communications
- Maintain existing regulatory filings/ licenses, managing updates and related change control processes
- Responsible for implementing global regulatory and roadmaps through understanding the competitive market landscape can product marketing strategy
- Advises product design teams on regulatory strategy and requirements for specific new products / solutions
- Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance
- Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements and product registrations such as CE marking and clinical evaluations
- Develops and facilitate regulatory submissions, for new products / solutions, existing products / solutions.
- Reviews and validates marketing and labeling materials
You are a part of
The Philips Hospital Respiratory Care business has three locations in the United States. Our products include invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment. We believe that by understanding our customers’ problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device.
Skills and experience
- Bachelor’s degree (Master’s preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
- Experience with ventilators strongly preferred.
- Minimum of 5 years of experience in the medical device industry (EU MDD/MDR, Health Canada, US FDA class II or class III, etc.).
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
- Must have personal experience with successful preparation and submission of 510(k) submissions.
- Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 highly desirable.
- Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
- RAPs RAC strongly preferred. ASQ certifications also desirable.
- 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.
- Strong background in Design Controls.
- Experience in supporting international registrations and/or clinical investigations.
- Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
- Proficient computer skills in Microsoft Office.
- Understand LEAN concepts, methodologies and deployment.
- May require 20% travel annually with possibly some international.
We offer you
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.
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.
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