Our client is currently seeking a Regulatory Affairs Associate
This job will have the following responsibilities:
* The Regulatory Affairs Specialist works with direct supervision to bring medical devices to market and ensure ongoing compliance while continuing to develop their regulatory skills. Participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes.
* Work with minimum supervision, conferring with more senior staff when indicated. Keep supervisor regularly apprised of project status.
* Collaborate with New Product Development Teams to ensure US, EU and other international regulatory requirements are incorporated as part of the development process.
* Evaluate medical device regulations and develop strategies for bringing products to market.
* Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.
* Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support.
* Assess global impact of changes to launched products and support notifications/submissions as required.
* Review labeling and marketing literature for compliance with regulatory requirements. Additional tasks may include:
* Determining and communicating submission and approval requirements
* Compiling, preparing, reviewing and submitting regulatory dossiers to authorities
* Interfacing and coordinating directly with FDA, Notified Body reviewers, and other regulatory agencies on submissions, approvals or other issues.
* Reviewing and approving change documentation for regulatory impact on launched products.
* Providing regulatory input for and appropriate follow-up to inspections and audits
* Reviewing and approving labeling, advertising and promotional items for compliance before release
* Assisting in the development, implementation, and maintenance of regulatory procedures to ensure ongoing compliance of new and existing products.
* Preparing and updating US product registrations and listings
* Providing regulatory input in CAPAs/NCs.
* Assisting in the establishment and maintenance of regulatory information systems both electronically and hard copy.
* Participating in process improvement activities and projects.
* Assisting in complex projects and performing delegated tasks as required.
* Ensuring compliance with product post-market or clearance requirements (progress reports, annual reports etc.)
* Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
* Identifying issues early in the submission preparation process that could impact product launch
* Communicating and negotiating with regulatory authorities and stakeholders under supervision of more experienced RA team-members.
* Ensuring project team(s) and RA management remain informed regarding all regulatory agency/Notified Body correspondence.
Qualifications & Requirements:
* Education: BA/BS in Science, Engineering, Legal, or Regulatory, Advanced degree and/or RAC(s) preferred Experience:
* 3+ years of experience within medical device or other regulated industry
* Knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD)and applicable guidance documents. Familiarity with EU Medical Device Regulation (MDR) and additional international regulations preferred.
* 510(k), IDE, PMA, CE Technical File/Design Dossier preparation, review, and submission experience.
* Experience interacting directly with FDA and Notified Body reviewers/inspectors.
* Understanding of the FDA device listing and establishment registration process.
* Demonstrated abilities and skills in the following key areas:
* Analytical and writing skills
* Organizational and planning skills
* Advanced PC skills (MS Outlook, Word, PowerPoint, Excel)
* Interpersonal communication, collaborative team work, and negotiation skills
* Complying with constantly changing regulatory procedures; reprioritizing work effectively
* Identifying and correcting errors and inconsistencies (e.g. grammatical, contextual, etc.)
* Rapidly building product knowledge and understanding of highly technical and scientific regulatory activities