Regulatory Affairs Specialist – FDA Submissions for Devices

Goldbelt, Inc.; Frederick (MD); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company matching

Paid time off and professional develop

Job summary

Goldbelt Apex is seeking a Regulatory Affairs Support – WEMT to develop and review regulatory strategies for drugs, biologics, blood products and medical devices. You will prepare/ review INDs/NDAs/PMAs/510(k)s, support FDA interactions, and advise on regulatory risk throughout the product lifecycle.

The role requires navigating regulatory submissions and lifecycle considerations, with up to 20% travel. A strong background in regulatory affairs for medical products is essential.

Qualifications

• In-depth understanding of regulatory requirements throughout the medical product lifecycle.
• Strong understanding of drugs, biologics, blood/blood products, medical devices and/or related medical solutions.
• Ability to work independently and collaboratively.

Responsibilities

• Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
• Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation reports.
• Support FDA/regulatory agency interactions.
• Conduct regulatory gap analyses.
• Advise product managers and IPTs on regulatory risk and product lifecycle strategy.

Skills

FDA regulatory affairs

Regulatory submissions

Drugs, biologics and/or medicalDevices

Clinical/preclinical development

Analytical problem solving

Independent and collaborative work

Job description

Goldbelt Apex is seeking a Regulatory Affairs Support – WEMT to develop and review regulatory strategies for drugs, biologics, blood products and medical devices. You will prepare/ review INDs/NDAs/PMAs/510(k)s, support FDA interactions, and advise on regulatory risk throughout the product lifecycle.

The role requires navigating regulatory submissions and lifecycle considerations, with up to 20% travel. A strong background in regulatory affairs for medical products is essential.