Job Description
job summary:
Raleigh client seeking contractor for onsite Regulatory Affairs Specialist, M-F
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.
location: Raleigh, North CarolinaEssential 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
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.
qualifications:Required:
- 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
skills: FDA Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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