Regulatory Affairs SME: Military Medical Solutions

Bering-Alaka'ina Holdings, LLC; Frederick (MD); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

401K with company match

Medical insurance

Dental insurance

Disability insurance

Life insurance

Tuition reimbursement

Paid time off

11 paid holidays

Job summary

Bering-Alaka`ina Holdings, LLC in Frederick, MD seeks a Regulatory Affairs Support SME to provide expert guidance on regulatory strategies for military-relevant medical solutions across drugs, biologics, and devices.

You will develop submission plans (INDs, NDAs, 510(k)s), review FDA guidelines, manage agency interactions, train teammates, and collaborate with R&D, manufacturing, clinical, and marketing to maintain lifecycle compliance.

Qualifications

• Bachelor’s degree required.
• 6–8 years of regulatory affairs experience.
• Expertise in regulatory requirements for drugs, biologics, and devices.
• Strong understanding of product development lifecycle and regulatory requirements.
• Ability to work independently and in a team.
• Excellent analytical and problem-solving skills.

Responsibilities

• Provide regulatory guidance on drugs, biologics and devices for military-relevant medical solutions.
• Develop and review regulatory strategies, submission plans (INDs, NDAs, PMAs, 510(k)s, etc.).
• Support regulatory agency interactions and manage commitments.
• Conduct gap analyses of processes against current regulatory requirements.
• Train and mentor team on regulatory practices.
• Collaborate with R&D, manufacturing, clinical and marketing to ensure regulatory compliance throughout the product lifecycle.
• Advise leadership on regulatory risks and opportunities.
• Develop Integrated Master Plan for FDA and non-FDA regulatory and clinical activities.

Skills

Regulatory affairs

Regulatory strategy

Drugs/biologics/devices

Lifecycle management

Analytical skills

Independent worker

Education

Bachelor's degree

Job description

Bering-Alaka`ina Holdings, LLC in Frederick, MD seeks a Regulatory Affairs Support SME to provide expert guidance on regulatory strategies for military-relevant medical solutions across drugs, biologics, and devices.

You will develop submission plans (INDs, NDAs, 510(k)s), review FDA guidelines, manage agency interactions, train teammates, and collaborate with R&D, manufacturing, clinical, and marketing to maintain lifecycle compliance.