Regulatory Affairs Specialist - Medical device Experience Job at Accuro, Raleigh, NC

dml2QlJRa01RQkllRHdseFk1L1BONW41Smc9PQ==
  • Accuro
  • Raleigh, NC

Job Description

Job Title: Regulatory Affairs Specialist – Medical device Experience

Job Location: Raleigh, NC

Job Type: 8+ Months contract

Job Description:

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.

Job Responsibilities:

  • Support strategy development for US FDA class III medical devices and combination products in the post-market lifecycle
  • 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
  • Prepare, review, and submit regulatory submissions, including PMA supplements and reports for class III medical devices
  • Maintain documentation and databases in accordance with internal procedures and applicable regulations, standards, and guidelines (e.g. FDA, ISO, USP)
  • 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
  • Collaborate with cross-functional teams (e.g., Quality, Operations, Marketing, Supply Chain) to ensure regulatory requirements are met in throughout the product lifecycle
  • Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices

Skills & Experience Required:

  • Bachelor's degree in relevant field
  • 4+ years’ experience in medical device industry
  • 2+ years’ direct experience in medical device regulatory affairs, preferably with FDA class III devices
  • Knowledge of Quality Management System standards, including ISO 13485 and ISO 9001
  • Proficiency in MS Office (Excel, PowerPoint and Word)
  • Knowledge of medical device regulations and governing laws such as 21 CFR 814, 21 CFR 814, 21 CFR 820
  • Strong analytical, investigative, and organizational skills
  • Prior experience with PMA Class III devices

Job Tags

Contract work,

Similar Jobs

Manor Roofing & Restoration Services

Account Manager (sales) Job at Manor Roofing & Restoration Services

Account Manager Residential & Commercial Exteriors Manor Roofing & Restoration is a well-established, community-focused exterior construction company with nearly 20 years of experience. We specialize in roofing, siding, gutters, windows/doors, and deckingand we take...

APR&R LLC dba New England Truck Center

Body Shop Manager Job at APR&R LLC dba New England Truck Center

 ...The Body Shop Manager will lead and direct the daily operations of the Exeter, NH and Bow, NH auto-body repair departments, focusing on profitability, employee retention, and overall customer satisfaction. This position will report directly to the Vice President of Service... 

GetGo Café + Market

Refrigeration Technician Job at GetGo Café + Market

 ...repairing, and servicing refrigeration, and air conditioning systems. Restoring and repairing faulty or inoperative refrigeration and HVAC systems and associated equipment. Ability to diagnose mechanical and electrical problems both inside and outside of equipment. Have... 

Supreme Staffing

Loss Prevention Officer Job at Supreme Staffing

 ...position requires a proactive approach to surveillance and conflict management, along with strong skills in report writing and criminal investigation. Responsibilities Monitor premises through CCTV and other surveillance systems to detect suspicious activities.... 

iRiS Recruiting Solutions

Assistant Project Manager - Commercial Construction Job at iRiS Recruiting Solutions

 ...Assistant Project Manager Commercial Construction (Charlotte, NC) Were partnering with a well-established, nationally active general contractor that continues to expand its footprint in the Charlotte market. Theyre looking to add an Assistant Project Manager to...