Senior Regulatory Specialist

Sr. Regulatory Affairs Specialist (Through mid December 2025 / / Jacksonville, FL) :

Candidate is required to work on site in Jacksonville, FL at least 3 days per week

HM's Top Needs :

• Experience with US and EU change assessments
• Experience reviewing and support MDR Clinical Evaluation documentation as a Regulatory stakeholder (not necessarily as an author)
• Willingness to be adaptive, collaborative, and supportive of the Regulatory team

Education / Experience Required : Bachelor’s with 4-6 years’ experience in RA, advanced degree with 2-4 years’ experience in RA

Duties :

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have :

• 2-4 years’ experience in regulatory (medical devices)
• Strong experience with change assessments for EU / US marketed products
• EU Technical Files and / or 510(k) authorship experience
• Strong organizational skills to manage multiple projects simultaneously under limited supervision
• Analytical thinking to identify potential regulatory issues and develop effective solutions.
• Demonstrated excellent organizational skills
• Demonstrated technical writing skills
• Excellent attention to detail
• Excellent communication skills
• Experience as regulatory lead in core teams for sustaining and development projects
• Expert proficiency in Microsoft Office suite, including Word and Excel
• Proficient at managing multiple projects at once
• Regulatory assessment of change orders emphasis on US and EU
• Familiar with ISO 13485, FDA Medical Devices Part 820, and Medical Device Good Documentation Practices

Nice to Have :

• Adobe software skills
• RAPS Regulatory Affairs Certification (RAC)