Regulatory Affairs Specialist - Military Medical Solutions

Kapili Services, LLC; Frederick (MD); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

401K plan with company match

Medical, dental, disability, and life

Tuition reimbursement

Paid time off

11 paid holidays

Job summary

Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Specialist to support our government customer at Fort Detrick, MD. The role focuses on regulatory strategies, submissions planning, and ensuring compliance across medical devices, drugs, and biologics throughout the lifecycle.

The ideal candidate holds a Bachelor's degree with at least four years of relevant experience, capable of working independently and with cross-functional teams to support regulatory requirements and FDA

Qualifications

• Bachelor's degree required.
• Minimum of four years of relevant experience.
• Expertise on regulatory requirements for drugs, biologics, and devices.
• Strong understanding of product development lifecycle and regulatory requirements.
• Ability to work independently and in a team.

Responsibilities

• Provide specialized guidance on regulatory requirements, strategies, and processes for product development and lifecycle management.
• Advise on drugs, biologics, and devices for military-relevant medical solutions; plan submissions and communicate with regulators.
• Assist in regulatory agency interactions, including meetings and response to queries.
• Conduct gap analyses of existing processes against regulatory requirements.
• Provide training on regulatory requirements and best practices to team members.
• Collaborate with R&D, manufacturing, clinical, and marketing to ensure regulatory compliance throughout the product lifecycle.
• Communicate regulatory risks, opportunities, and issues to product managers and leadership.
• Identify RA strategies to optimize product development across the portfolio.
• Review and analyze clinical documents and safety data to ensure FDA compliance.
• Plan for future trials and review pre-clinical documents; maintain current FDA policy information.
• Assist in developing Integrated Master Plan/IMS for regulatory and clinical activities.
• Perform other duties as assigned.

Skills

Regulatory affairs

FDA regulations

Lifecycle management

Analytical skills

Independent worker

Education

Bachelor's degree

Job description

Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Specialist to support our government customer at Fort Detrick, MD. The role focuses on regulatory strategies, submissions planning, and ensuring compliance across medical devices, drugs, and biologics throughout the lifecycle.

The ideal candidate holds a Bachelor's degree with at least four years of relevant experience, capable of working independently and with cross-functional teams to support regulatory requirements and FDA