Regulatory Operations Specialist
Regulatory Operations Specialist
In this role, you have the opportunity to
Utilize your expertise and knowledge of regulatory requirements in developing Technical Documentation (Technical Files) compliant with the new EU MDR requirements.
You are a part of
You will have exposure to a multitude of indications, medical devices, and workflow solutions. This position partners 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.
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
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 in international and US FDA 510(k) regulatory submissions
- 5+ years of experience writing and assembling technical documentation files or design dossiers
- 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
- Ability to work with international cultures
- 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 teams
- Good communication skills, written and verbal
- Proficient computer skills in Microsoft Office.
- May require 5% travel annually with possibly some international
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa
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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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