What are the responsibilities and job description for the Regulatory Affairs Specialist position at Alexander Technology Group?
The Alexander Technology Group is looking for Regulatory Affairs Associate to join their team. This candidate should have experience generating high-quality regulatory documentation while addressing the unique challenges of combination product compliance.
This is full-time
No 3rd party applicants will be considered
Skill Set/Responsibilities:
Key Responsibilities:
- Act as primary regulatory strategy owner combination regulatory submission pathway.
- Assist in drafting, editing, and formatting NDA and 510k content for combination products, including components related to drugs and devices.
- Collaborate with internal teams to gather, organize, and compile required data for combination product submissions.
- Conduct quality reviews of submission documents to ensure accuracy and consistency with regulatory requirements.
- Maintain version control and facilitate the timely delivery of documents for regulatory submissions.
- Stay updated on regulatory trends and guidelines specific to combination products and incorporate them into content preparation.
Preferred Skills:
- Experience in regulatory submissions or medical writing, particularly for combination products.
- Knowledge of electronic submission processes, such as eCTD, eSTAR
- Familiarity with design control and quality systems regulations relevant to devices (e.g., 21 CFR Part 820).
If interested, please send resume to Jpolombo@alexandertg.com
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