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Alliance of Professionals & Consultants, Inc.
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Regulatory Affairs Specialist
6501 Six Forks Road, Suite 430 Raleigh, NC 27615 US
Posted: 10/31/2025
2025-10-31
2025-12-09
Industry: Professional Non-Technical
Job Number: 39860
Work Location: Hybrid
Job Description
Job Title: Regulatory Affairs Specialist
Type of Engagement: 8-month contract (Not open to 3rd party C2C consultants. Visa sponsorship is not available)
Work Location: Hybrid position in Raleigh, NC
Job Overview:
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.
Essential Job Responsibilities:
Required Skills & Experience:
Technical & Functional Skills:
Essential Skills - Lead Self:
Essential Skills - Lead Others:
Big Bonus Points if you Have:
Job Requisition # 39858
A reasonable estimate of the pay range for this role is $43.59 - $48.59 per hour. The disclosed pay range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. The compensation decisions are dependent on the facts and circumstances of each case, such as skills and experience levels.
Meet APC
APC is a professional staffing and services organization focused on engaging people and positively impacting lives. As “Professionals serving Professionals”®, we take pride in providing our employees and contractors with the highest level of customer service and support.
APC is committed to creating a diverse work environment and is proud to be an Equal Opportunity Employer. All qualified candidates will receive consideration without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, genetics, or veteran status.
#LI-RL1
Type of Engagement: 8-month contract (Not open to 3rd party C2C consultants. Visa sponsorship is not available)
Work Location: Hybrid position in Raleigh, NC
Job Overview:
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.
Essential 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.
- Document management - Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices.
Required Skills & Experience:
- 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)
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.
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 learn
Essential Skills - Lead Others:
- Collaboration
- Cultural Awareness
- Empathy
- Expectation Management
- Friendliness
- Leadership
- Motivate & Influence
- Persuasion
- Project Management
- Problem Solving
- Rapport Building
- Respectfulness
Big Bonus Points if you Have:
- Prior experience with PMA Class III devices
- Strong communication skills
- Ability to quickly adapt to changes in fast-paced environment
Job Requisition # 39858
A reasonable estimate of the pay range for this role is $43.59 - $48.59 per hour. The disclosed pay range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. The compensation decisions are dependent on the facts and circumstances of each case, such as skills and experience levels.
Meet APC
APC is a professional staffing and services organization focused on engaging people and positively impacting lives. As “Professionals serving Professionals”®, we take pride in providing our employees and contractors with the highest level of customer service and support.
APC is committed to creating a diverse work environment and is proud to be an Equal Opportunity Employer. All qualified candidates will receive consideration without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, genetics, or veteran status.
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APC is committed to creating a diverse work environment and is proud to be an equal opportunity employer. All qualified individuals will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, genetics, or veteran status. **California Consumer Protection Act