Job Description
About Accorto
Accorto Regulatory Solutions is a regulatory and quality consulting firm dedicated to supporting life sciences organizations in bringing safe, effective, and compliant products to market. We partner with companies across the FDA-regulated products landscape to provide expertise in regulatory strategy, quality, and compliance, helping navigate complex requirements with clarity and confidence.
About the Role
We are seeking a mid-level Regulatory Writer to support the preparation of regulatory documentation related to manufacturing, product controls, and quality systems for FDA-regulated products. This role supports programs across medical devices, combination products, pharmaceuticals, and harm-reduction products.
The Regulatory Writer will work closely with regulatory, quality, manufacturing, and technical subject matter experts, both inside of Accorto and with the client and their respective supply chains, to translate complex technical and manufacturing information into clear, accurate, and compliant regulatory documentation. The ideal candidate will have experience working in FDA-regulated environments and familiarity with manufacturing processes and quality systems, including cGMP, ISO13485, TPMP, and FDA QMSR requirements.
Key Responsibilities
- Draft, review, and edit regulatory documentation related to manufacturing processes, product specifications, controls, and validation activities.
- Support preparation of regulatory submissions for U.S. and global regulatory authorities.
- Collaborate with regulatory, quality, and manufacturing teams to gather technical information for regulatory documentation.
- Review technical and manufacturing data to ensure accuracy, completeness, and regulatory compliance.
- Ensure documentation aligns with applicable regulatory requirements, including FDA Quality Management System Regulation (21 CFR 820), TPMP, cGMP requirements (21 CFR 210/211), and ISO. Perform gap assessments on the client’s existing system related to these standards and develop potential remediation strategies/plans.
- Assist in the preparation of regulatory responses to FDA questions and requests for additional information.
- Maintain organized documentation and version control consistent with good documentation practices.
Qualifications
- Bachelor’s degree in a scientific, engineering, or technical discipline.
- 5+ years of experience supporting regulatory documentation or regulatory submissions in FDA-regulated industries.
- Experience working with medical devices, pharmaceuticals, or combination products.
- Familiarity with manufacturing processes and quality systems (cGMP, TPMP, and/or FDA QMSR) required.
- Experience supporting regulatory submissions (e.g., 510(k), PMA, IND/NDA) or similar regulatory documentation. Knowledge of GLP is a plus.
- Strong technical writing, editing, organizational, and customer-facing communications skills.
- Ability to travel up to 10% of the time.
- Ability to handle multiple projects and priorities simultaneously.