Regulatory Affairs Specialist

Job Description

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 Carolina
job type: Contract
salary: $48 - 51 per hour
work hours: 8 to 4
education: Bachelors

responsibilities:

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

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.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.