What are the responsibilities and job description for the Freelance Regulatory Affairs Expert position at Evon Medics, LLC?
Evon Medics, LLC is seeking an experienced Regulatory Affairs Expert with over 10 years of hands-on direct experience in FDA regulatory processes, particularly with CDRH and CDER. The candidate will contribute to IND submissions, NDA submissions, 510(k) submissions, regulatory strategy, and case handling. This role requires direct collaboration with our quality consultants and Head of Product Development to ensure the successful approval of our medical device products.
Key Responsibilities:
• Hands-on contributions to FDA submissions including IND, NDA, 510(k), PMA, De Novo, and other regulatory filings.
• Develop and execute regulatory strategies to ensure compliance with FDA requirements.
• Provide hands-on support in preparing, reviewing, and submitting regulatory documents.
• Address FDA queries, disputes, and case handling effectively.
• Work closely with EM’s regulatory team and product development team to align regulatory pathways with product goals.
• Stay up-to-date with evolving FDA regulations and industry best practices.
Qualifications & Experience:
• 10 years of FDA regulatory affairs experience, particularly with CDRH (medical devices) and CDER (pharmaceuticals).
• Proven track record of successful IND and NDA submissions.
• Expertise in 510(k), PMA, De Novo submissions is a strong plus.
• Strong understanding of FDA interactions, responses, and regulatory negotiations.
• Ability to work independently and collaborate with cross-functional teams.
• Experience with hands-on submission processes, including document preparation and regulatory writing.
Preferred Qualifications:
• Prior direct FDA experience regulatory approvals for medical or pharmaceutical products. Previous employment with FDA is a bonus.
• Strong analytical, problem-solving, and communication skills.
We offer a competitive per hour rate and potential opportunity to convert into a full time role. If you believe you have a strong candidacy for this role and unable to apply on this portal, kindly send your resume and cover letter to recruitment@evonmedics.org with the subject line “Freelance Regulatory Affairs Expert”. Also indicate your earliest start date and weekly availability, if considered for the role.
View the company website https://www.evonmedics.com and our LinkedIn page
https://www.linkedin.com/company/evon-medics-llc for more information about the company