Regulatory Operations Specialist

Job Title – Regulatory Operations Specialist
 
Job Location – Pewaukee WI
 
Length – Contract (12 Months+)
 
As a Regulatory Operations Specialist, you will use your expertise and knowledge of regulatory requirements in updating and developing Technical Files and Pre-Market Approval Packages for Class I, IIa, and IIb medical Devices in preparation for EU MDR Compliance. You will participate, as a core team member in the Diagnostic Imaging Business Groups European Union (EU) Medical Device Regulation (MDR) Program supporting multiple Business Units to bring their medical devices EU MDR complaint ensuring documentation is adequate for successful regulatory submissions. These packages represent the intended use, product design, verification and validation, clinical evaluation and manufacturing technologies of our devices. You will partner with cross-functional teams within the organization, to ensure the regulatory requirements and globally harmonized standards are understood and represented in ways of working during product design, in change control and risk management, as well as manufacturing processes. Your expert knowledge of the changing EU regulatory environment will ensure our products 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 and EU MDR compliance.
 
 Your responsibilities
 o Support revising Technical Files
 o Plan, generate, and coordinate regulatory submissions for product/solution licensing approvals in the EU market
 o Excellent working knowledge of regulations, including the EU Medical Device Regulation (MDR)
 o Supports development of the regulatory plan, guidance on risk assessment for CE marking ad clinical evaluations
 o 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
 o Transparent sharing current, new and changing regulatory requirements, using your expert and proper interpretation to support medical device registrations in the EU market
 o Develop compliant Technical File documentation which supports successful approval to market
 o Work closely with other regulatory and clinical professionals to ensure all product and clinical information is adequately and correctly represented
 o Ensure Declarations of Conformity correctly represent all standards and regulatory requirements applicable to current technologies in the device
 o Identify issues that need resolution to ensure continued registrations in all global markets planned for commercialization
 o Participate in cross-functional meetings to provide regulatory perspective and interpretative knowledge
 o Knowledge of how to, or a willingness to learn to write protocols, reports, and other documentation to support technical documentation updates
 
We are looking for 
 o An individual with a legal or regulatory discipline as related to medical device products 
 o 2+ years of experience in international and domestic regulatory submissions 
 o 2+ years of experience writing and assembling technical files or design dossiers 
 o Experience in associated regulations relevant to labeling and use of international symbols 
 o Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape 
 o Ability to work nimbly, innovative approach to problem solving 
 o Ability to work with international cultures 
 o Knowledge of basic regulatory requirements for CE marking and UDI 
 o Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment 
 o Interest in and passion for the medical device industry, bringing innovation to market 
 o Effective working in multidisciplinary teams 
 o Good communication skills, written and verbal
 
Best,
Kushal Shah
APN Software Service INC
kushal@apninc.com
609-357-9180 (Direct)

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