Regulatory Affairs Specialist

2 weeks ago

Raleigh, NC, United States Pacer Group Full time
Job Title: Regulatory Affairs Specialist

Job Location: Raleigh, NC 27615

Job Duration: 7 months

Job Summary:
  • 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:
  • 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 in throughout the product lifecycle.
Technical & Functional Skills:
  • 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. Demonstrate curiosity preferred.
  • Ability to work under pressure, prioritize, and handle multiple tasks.
  • Self-starter with results-oriented mindset.
  • Excellent written and verbal communications skills.
Minimum Qualifications:
  • University degree; scientific discipline preferred, or the required years of direct experience.
  • 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)
Preferred Qualifications:
  • Prior experience with PMA Class III devices
  • Strong communication skills
  • Ability to quickly adapt to changes in fast-paced environment
Physical Requirements:
  • This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.
  • Document management • Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices.
Essential Skills - Lead Self:
  • Attention to Detail
  • Analytical Skills
  • Time Management
  • Digital Acumen
  • Problem Solving
  • Emotional Intelligence
  • Resiliency
  • Communication Leadership
  • Collaboration
  • Project Management
  • Motivate & Influence
Essential Skills - Lead Others:
  • Leadership
  • Collaboration
  • Project Management
  • Motivate & Influence

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