Offer summary

Qualifications:

Up to 3 years of experience with US and EU MDR medical devices and MDSAP., Degree in a scientific field or experience in quality assurance., Ability to assist in authoring EU MDR CE Technical Files., Certification in auditing, with familiarity in biological assessments and risk management..

Key responsibilities:

Draft, assemble, and file documentation for regulatory submissions.

Ensure submissions comply with relevant statutes, regulations, and guidelines.

Assist in preparing CE Technical Files under EU MDR.

Conduct internal, supplier, and for-cause audits to ensure compliance.

Job description

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:

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 www.consultnet.com .

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.

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