Regulatory Affairs Specialist

Regulatory Affairs SpecialistMaxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Regulatory Affairs Specialist.Job Title: Regulatory Affairs SpecialistJob Type: ContractJob Location: 6501 Six Forks Rd. Raleigh, NC 27615Work Schedule: On-siteStarting rate: $51, Based on experienceOnsite M-F (hybrid, 2-3 days per week on site) Local Candidates Preferred The Regulatory Affairs Specialist will be responsible for supporting regulatory activities for existing US FDA class III medical devices. This role provides support to currently-marketed products, involves evaluating proposed product and process changes, assessing documentation and providing guidance to ensure regulatory compliance. The Regulatory Affairs Specialist will work collaboratively with internal stakeholders. From preparing and authoring regulatory submissions to providing critical input on cross-functional project teams and developing regulatory strategy, this role is an excellent opportunity for the right regulatory professional. The ideal candidate will be curious, analytical and a self-starter, unafraid to ask questions or over-communicate.Major Duties Description:Regulatory strategy: Support strategy development for US FDA class III medical devices and combination products in the post-market lifecycle.Regulatory assessments: Review product and process changes and conduct regulatory assessments, ensuring the appropriate regulatory strategies are communicated to internal stakeholders. Conduct risk assessments and provide recommendations to mitigate regulatory risks.Regulatory submissions: Prepare, review, and submit regulatory submissions, including PMA supplements and reports for class III medical devices.Regulatory compliance: Maintain documentation and databases in accordance with internal procedures and applicable regulations, standards, and guidelines (e.g. FDA, ISO, USP).Regulatory interface and communication: Respond to regulatory agencies and coordinate responses with subject matter experts. Ensure internal stakeholders are apprised of inquiries from health authorities during the submission approval process according to departmental communication cascades.Cross-functional collaboration: Collaborate with cross-functional teams (e.g., Quality, Operations, Marketing, Supply Chain) to ensure regulatory requirements are met throughout the product lifecycle.Document management: Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices.Essential Skills - Lead Self: Active Listening Adaptability Analytical Skills Attention to Detail Communication Curiosity Digital Acumen Emotional Intelligence Enthusiasm Flexibility Patience Planning Resiliency Sincerity Self Starter Sense of humor Stress Resistance Time Management Willingness to learnEssential Skills - Lead Others: Collaboration Cultural Awareness Empathy Expectation Management Friendliness Leadership Motivate & Influence Persuasion Project Management Problem Solving Rapport Building RespectfulnessSince 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.Please apply with your most current resume. Maxonic