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