Computer Technologies Consultants, Inc. (CTC, Inc.) is seeking a Regulatory Affairs Support Specialist to support the Defense Health Agency (DHA) in Frederick, MD.
Why Should You Be Interested?
- Direct hire position
- Competitive compensation and comprehensive benefits
- Mid-size company with room for growth
Position Title: Regulatory Affairs Support Specialist
Position Location: This position is Full-Time, Hybrid in Frederick, MD.
Daily Responsibilities:Help bring breakthrough medical technologies to the Warfighter by supporting the regulatory pathways that move innovative products from development to deployment. In this role, you will work closely with scientists, clinicians, and product-development teams to support regulatory submissions, FDA interactions, and compliance activities for drugs, biologics, medical devices, and other advanced medical solutions. This is an exciting opportunity to contribute to cutting-edge military medical programs while building expertise at the intersection of science, regulation, and product development.
- Support regulatory strategies and lifecycle activities for drugs, biologics, blood products, medical devices, and other military-relevant medical solutions.
- Research and summarize applicable FDA regulations, guidance, policies, and industry standards and identify potential impacts on developmental programs.
- Assist in preparing, reviewing, formatting, and maintaining regulatory submissions, including INDs, NDAs, PMAs, 510(k)s, Technical Files, and Clinical Evaluation Reports.
- Coordinate regulatory documentation, stakeholder inputs, quality reviews, version control, and submission-readiness activities.
- Support regulatory-agency meetings and communications by preparing materials, documenting minutes, tracking questions and commitments, and assisting with responses.
- Assist with regulatory gap analyses and document compliance gaps, risks, dependencies, and recommended actions.
- Review and summarize clinical protocols, investigator brochures, progress reports, safety information, and preclinical and clinical documentation.
- Maintain current regulatory files, submission histories, correspondence, decision records, trackers, and regulatory-intelligence resources.
- Participate in cross-functional IPT activities and communicate regulatory status, deadlines, risks, and action items to product managers and stakeholders.
- Support Integrated Master Plans and Schedules for regulatory and clinical activities, including deliverables, meetings, dependencies, milestones, and estimated timelines.
Required Years of Experience (min):
- Minimum four (4) 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 four (4) 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 InformationTBD
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.
