Computer Technologies Consultants, Inc. (CTC, Inc.) is seeking a Regulatory Affairs Subject Matter Expert to support the Defense Health Agency (DHA) in Frederick, MD. 

With offices in Washington DC and San Diego, CA, CTC is a leading technology company providing lifecycle IT, data analytics, cloud managed hosting services, agile software development, DevOps, Test Automation, Cyber Security, and infrastructure solutions. Additionally, we provide Professional Talent Acquisition Services as we proudly support the unique needs of U.S. Defense, Intelligence, and Federal Civilian agencies as well as Fortune 1000 companies.

Got the Government Contractor Blues? Looking for a company that cares and goes beyond just filling another contract billet? Well look no further! Experience this family-oriented company who takes pride in you and will help you grow where your passions lie. Holding many Defense & Federal government contracts around the globe, with our client you have the opportunity to take on new and evolving challenges, aim beyond what you think you are capable of and work in collaborative, dynamic, and high-tempo environments.  Our clients’ employees are their most valued asset and they invest in their people because they are in it for the long term. They are committed to your success and well-being and offer competitive benefits packages, salaries, bonus/award programs, and a high potential for professional growth and job opportunities world-wide.

Why Should You Be Interested?

• Direct hire position
• Competitive compensation and comprehensive benefits
• Mid-size company with room for growth

Position Title: Regulatory Affairs Subject Matter Expert

Position Location: This position is Full-Time, Hybrid in Frederick, MD.

Daily Responsibilities: 

Help accelerate the development of lifesaving medical products for the Warfighter by serving as a regulatory expert at the forefront of military medical innovation. In this role, you will guide the regulatory strategy for drugs, biologics, medical devices, and other advanced medical solutions, working closely with scientists, clinicians, product managers, and government leaders. Your expertise will directly influence the successful development, approval, and fielding of critical capabilities that support military readiness and improve health outcomes. 

• Provide specialized guidance and support and serve as a technical resource, offering in-depth expertise on relevant regulatory requirements, strategies, and processes to ensure successful product development, submission, and lifecycle management. 
• Provide expert advice and guidance on drugs, biologics, and devices and their application to the development of military-relevant medical solutions. 
• Develop and review regulatory strategies, including submission planning, dossier preparation, and communication with regulatory agencies. 
• Evaluate and interpret regulatory guidelines, directives, and policies, and assess their impact on developmental programs. 
• Prepare and review regulatory submissions, including but not limited to INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting submission packages and minutes, audit and inspection reports.  
• Support regulatory agency interactions, including preparation for meetings, communication with Sponsors, responses to queries, and management of commitments. 
• Conduct gap analyses of existing processes and documentation against current regulatory requirements. 
• Provide training and mentorship to team members on regulatory requirements and best practices. 
• Stay current on changes to relevant regulations, guidelines, and industry standards and communicate these changes to the team. 
• Collaborate with cross-functional teams, including R&D, manufacturing, clinical, and marketing, to ensure regulatory compliance throughout the product lifecycle.  
• Proactively communicate with and advise product managers, IPTs, and leadership on regulatory risks, opportunities, and issues. 
• Collaborate as necessary to identify regulatory affairs strategies to optimize product development across the portfolio.  
• Review and analyze summaries, progress reports, clinical protocols, investigator brochures, and safety profiles and safety surveillance data. 
• Facilitate an understanding of requirements for compliance with all applicable FDA regulations.  
• Understand and plan for future clinical trials and other pre-clinical trial milestones. 
• Coordinate and assist in the review of all pre-clinical trial documents.  
• Keep current files of all information disseminated by the FDA and other policy bodies that affect products and will interpret, synthesize, and incorporate the new information into the organization.  
• Assist in the development of a comprehensive Integrated Master Plan/IMS of FDA and non-FDA regulatory and clinical activities (e.g. tasks, documents, meetings,) to include estimated timelines required to support the product development of medical devices, drugs, biologics, blood and blood products and or other medical solutions.  

Required Years of Experience (min):       

• Minimum eight (8) years of experience supporting DoD, DHA, federal healthcare, acquisition, or program-management organizations

Required Degree:           

• Bachelor’s degree in a relevant area preferred 

Required Experience:                                  

• Minimum eight (8) years of relevant experience required 
• Have a strong understanding of the product development lifecycle and regulatory requirements at each stage. 
• In depth knowledge of development of drugs, biologics, blood and blood products, medical devices, and other medical solutions. 
• Possess strong problem-solving and analytical skills. 
• Be able to work independently and as part of a team. 

Required Clearance:

• U.S. citizenship required
• Background investigation

Pay Information

TBD

Please note: This range is based on our market pay structures. However, individual salaries are determined by a variety of factors including, but not limited to: business considerations, local market conditions, and internal equity, as well as candidate qualifications, such as skills, education, and experience.

Computer Technologies Consultants, Inc. is an Equal Opportunity Employer that provides employment opportunities for all qualified applicants without regard to race, color, religion, gender identity and/or expression, sexual orientation, age, mental or sensory differing abilities, protected veteran status, sex, national origin, or any other characteristic protected by applicable law. Computer Technologies Consultants, Inc. is devoted to diversity, equity, and inclusion.