Regulatory Affairs SME – Military Medical Devices & Biologics

Bering-Alaka'ina Holdings, LLC; Frederick (MD); Vor Ort; USD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

401K match

Medical insurance

Dental insurance

Disability insurance

Life insurance

Tuition reimbursement

Paid time off

11 paid holidays

Zusammenfassung

Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Subject Matter Expert to provide regulatory guidance for government-project medical solutions at Fort Detrick, Frederick, MD. The role requires deep expertise in drug, biologic, and device regulation and the ability to manage submissions and lifecycle activities.

Responsibilities include preparing regulatory strategies, interacting with regulatory agencies, and mentoring team members on current guidelines.

Qualifikationen

• Minimum of six to eight years of relevant regulatory affairs experience.
• Expertise on regulatory requirements, strategies, and processes for product development and lifecycle management.
• Experience with drugs, biologics, devices, and military-relevant medical solutions.

Aufgaben

• Provide specialized regulatory guidance and act as a technical resource for development, submission, and lifecycle management.
• Develop and review regulatory strategies including submission planning and dossier preparation; communicate with regulatory agencies.
• Support regulatory agency interactions, including meetings preparation and responses to queries; manage commitments.
• Conduct gap analyses of processes against current regulatory requirements and stay current on regulatory changes.
• Collaborate with R&D, manufacturing, clinical, and marketing to ensure regulatory compliance across the product lifecycle.

Kenntnisse

Regulatory affairs

Life sciences

FDA regulations

IND/NDAs/PMAs

Cross-functional collaboration

Ausbildung

Bachelor's degree

Jobbeschreibung

Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Subject Matter Expert to provide regulatory guidance for government-project medical solutions at Fort Detrick, Frederick, MD. The role requires deep expertise in drug, biologic, and device regulation and the ability to manage submissions and lifecycle activities.

Responsibilities include preparing regulatory strategies, interacting with regulatory agencies, and mentoring team members on current guidelines.