Regulatory Operations Specialist

Job Title: Regulatory Operations Specialist 
Duration: 12+ months contract with possible extension
Location: Gainesville FL

Requirements:
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 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 the EU market 
Develop compliant Technical File documentation which supports successful approval 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 technical documentation updates 
We are looking for 
An individual with a legal or regulatory discipline as related to 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 to labeling and use of international symbols 
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 
Knowledge of basic regulatory requirements for CE marking and UDI 
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

 

Please send me your confirmation that no one else has contacted you for this position apart from APN Team.

Thanks and Regards,
Sachin P.,
510-402-1063
sachin@apninc.com

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