Regulatory Operations Specialist

Here is a brief job description:
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 tbring 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, tensure 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 tglobal regulations, in order tprevent business disruption in any market. You will partner with other key regulatory professionals tdrive consistently good regulatory practices within Philips, contributing tseamless regulatory approvals and EU MDR compliance. 
Responsibilities 
Support revising Technical Files 
Plan, generate, and coordinate regulatory submissions for product/solution licensing approvals in the EU market 
Excellent working knowledge of regulations, including the EU Medical Device Regulation (MDR) 
Supports development of the regulatory plan, guidance on risk assessment for CE marking ad clinical evaluations 
Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance, Marketing and international geographies tdevelop a regulatory strategy for the business 
Transparent sharing current, new and changing regulatory requirements, using your expert and proper interpretation tsupport medical device registrations in the EU market 
Develop compliant Technical File documentation which supports successful approval tmarket 
Work closely with other regulatory and clinical professionals tensure all product and clinical information is adequately and correctly represented 
Ensure Declarations of Conformity correctly represent all standards and regulatory requirements applicable tcurrent technologies in the device 
Identify issues that need resolution tensure continued registrations in all global markets planned for commercialization 
Participate in cross-functional meetings tprovide regulatory perspective and interpretative knowledge 
Knowledge of how to, or a willingness tlearn twrite protocols, reports, and other documentation support technical documentation updates 
We are looking for 
An individual with a legal or regulatory discipline as related medical device products 
2+ years of experience in international and domestic regulatory submissions 
2+ years of experience writing and assembling technical files or design dossiers 
Experience in associated regulations relevant labeling and use of international symbols 
Ability tinterpret applicable regulations tensure compliance in a changing regulatory landscape 
Ability twork nimbly, innovative approach to problem solving 
Ability twork with international cultures 
Knowledge of basic regulatory requirements for CE marking and UDI 
Strong organizational skills, ability twork on multiple projects, and work effectively in a demanding, time-sensitive environment 
Interest in and passion for the medical device industry, bringing innovation tmarket 
Effective working in multidisciplinary teams 
Good communication skills, written and verbal
I look forward to hearing from you
 
Cordially,
 
Mohammed Abdul
 APN Software Services, Inc .
 39899 Balentine Drive, Suite 385, Newark, CA 94560 .
 Direct: 510.623.5049 | Fax: 510.623.5055 | Email: abdul@apninc.com
 
 

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