Overview
Remote
On Site
Compensation information provided in the description
Full Time
Skills
Regulatory Affairs
Documentation
Medical Devices
Quality Assurance
Customer Engagement
Risk Management
ISO 13485
AS9100
ISO 9000
Internal Auditing
Auditing
Management
Managed Services
Collaboration
Partnership
Value Engineering
Effective Communication
Law
Job Details
Regulatory Affairs Specialist
100% Remote from anywhere in Florida
6+ month contract to hire
$38.50- $52.00 an hour ($80k- $110k salary upon conversion)
Immediate hire with growing company. The Regulatory Affairs Specialist will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines .
Required Skills:
Welcome to ConsultNet and the family of companies, Tekne, SaltClick, TechBridge, and OmniMedia. As a premier national provider of technology talent and solutions, our expertise spans across project services, contract-to-hire, direct placement, and managed services both onshore and nearshore.
Celebrating more than 25 years of partnership with a diverse client base, we've crafted rewarding opportunities for our consultants, fostering high-performing teams that deliver impactful results.
Over the last few years thousands of consultants have found their calling with us in roles that have made a meaningful impact on their lives, enhanced their career, challenged them, and propelled them towards achieving their personal and professional goals. At the ConsultNet family of companies, we believe effective communication is crucial in aligning the right job with your unique skills and professional aspirations. To us, it's all about the personal approach we take and the values we uphold.
Our comprehensive service offerings cover a wide range of technology positions across key markets nationwide. Client more at .
We champion equality and inclusivity, proudly supporting an Equal Opportunity Employer policy. We welcome applicants regardless of Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other status protected by law.
100% Remote from anywhere in Florida
6+ month contract to hire
$38.50- $52.00 an hour ($80k- $110k salary upon conversion)
Immediate hire with growing company. The Regulatory Affairs Specialist will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines .
Required Skills:
- No more than 3 years experience in US and EU MDR medical devices and MDSAP
- Should have either QA experience or a degree in scientific field.
- Must be able to assist in author CE Technical Files under EU MDR.
- Must have experience in auditing, risk management, familiarity with biological assessments
- Must have experience with Post Market Clinical follow up, labeling requirements.
- AQS Certified
- Demonstrate certification for auditing
- Must have familiarity with QSR (21CFR820) and ISO13485 or similar regulated industry (eg AS9100, ISO9001, etc).
- Experience in internal audit, roving, spot, for cause audits and supplier audits.
Welcome to ConsultNet and the family of companies, Tekne, SaltClick, TechBridge, and OmniMedia. As a premier national provider of technology talent and solutions, our expertise spans across project services, contract-to-hire, direct placement, and managed services both onshore and nearshore.
Celebrating more than 25 years of partnership with a diverse client base, we've crafted rewarding opportunities for our consultants, fostering high-performing teams that deliver impactful results.
Over the last few years thousands of consultants have found their calling with us in roles that have made a meaningful impact on their lives, enhanced their career, challenged them, and propelled them towards achieving their personal and professional goals. At the ConsultNet family of companies, we believe effective communication is crucial in aligning the right job with your unique skills and professional aspirations. To us, it's all about the personal approach we take and the values we uphold.
Our comprehensive service offerings cover a wide range of technology positions across key markets nationwide. Client more at .
We champion equality and inclusivity, proudly supporting an Equal Opportunity Employer policy. We welcome applicants regardless of Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other status protected by law.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.