Job Description:
Centennial Technologies is looking for a Regulatory Affairs Specialist with a strong understanding of FDA regulatory processes for drugs, medical devices, or both. The ideal candidate will serve as a Subject Matter Expert (SME), offering in-depth guidance on the end-to-end regulatory lifecycle, including pre-submission planning, documentation requirements, and final approval processes.
This is a part-time opportunity (10–20 hours/week) with the potential to convert to full-time within 6 months.
Key Responsibilities:
- Provide subject matter expertise on the FDA regulatory lifecycle, including early-stage documentation, submission planning, and approval pathways for drugs and/or medical devices.
- Guide teams on the types of documents, data, and timelines typically required for FDA approval.
- Advise on compliance with applicable regulations including 510(k), IND, NDA, ANDA, BLA, and other relevant FDA submission types.
- Review and interpret FDA policies, guidance documents, and evolving regulations to ensure alignment with best practices.
- Support the development of compliant product documentation strategies.
- Collaborate cross-functionally with product and leadership teams to ensure regulatory requirements are considered throughout product development.
- Help identify regulatory risks and support long-term strategy development for commercial and federal markets.
Skills Required:
- Must have 2-5 year’s of experience working in regulatory affairs.
- In-depth knowledge of the FDA submission process, regulatory pathways, and lifecycle from pre-documentation to approval.
- Ability to translate complex regulatory processes into clear guidance for non-regulatory teams.
- Strong understanding of FDA guidance documents, GxPs, and federal health regulatory standards.
- Must possess excellent communication, documentation, and organizational skills.
- Ability to work independently with minimal oversight while aligning with broader company goals.
- Must have a Bachelor’s degree in a scientific or health-related field.
- Must be a U.S. Citizen or authorized to work in the United States.
Nice to have:
- Regulatory Affairs Certification (RAC)
Location:
Hybrid: 2 – 4 Days Onsite presence required in Leesburg or Tysons, VA (Subject to change)
About the Company:
Centennial Technologies Inc. (Centennial) is committed to a healthy work-life balance for our employees, and we have worked hard to foster an environment that enables employees to effectively prioritize both their professional and personal responsibilities. We make every effort to accommodate employees by providing flexible paid time off, a casual work atmosphere, frequent collaborative interaction, and the opportunity to continuously develop career skills. Centennial offers a competitive benefits package, which includes Medical, Dental, Short-Term Disability, Long-Term Disability, Life Insurance, 401k, Mass Transit Benefits, Paid Time Off, and Federal Holidays.
Our Culture is inclusive of:
We offer a supportive professional environment that promotes a healthy work-life balance, alongside performance management techniques that reward our top performers. Through employee surveys and open discussions, we ensure that management decisions are informed by team input. We provide paid training on the latest technologies and business practices, all while maintaining an employee-focused model. Our shared vision is centered on client success, which we achieve by cultivating long-term client relationships.
Equal Opportunity Employer:
Centennial is an equal opportunity employer and complies with all applicable federal, state, and local employment laws.
