Highlights
Compile and publish regulatory submissions using specialized publishing platforms and electronic submission gateways. Diagnostic and life sciences regulatory submissions, including 510(k), PMA, BLA, IND, IDE, and IVDR.
Numbers & Facts
| Location | Branchburg, NJ (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $27.43–$37.15 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
Description
Regulatory Submission Publishing Specialist
Location: Remote
Pay Rate: $27.43–$37.15/hr.
Duration: 1 Year
Job Description
Prepare, publish, validate, and electronically submit regulatory dossiers for diagnostic products across US, EU, and global markets.
Compile and publish regulatory submissions using specialized publishing platforms and electronic submission gateways.
Review submission validation reports, resolve publishing errors, and ensure regulatory submission quality and compliance.
Manage submission lifecycle activities, sequence planning, document traceability, and regulatory archiving.
Maintain regulatory document repositories and publication databases to support audit readiness and data integrity.
Implement publishing process improvements, automation, AI, and robotic process automation (RPA) to improve submission efficiency.
Support evolving global regulatory requirements and emerging regulatory pathways, including reliance pathways.
Education
Bachelor’s degree in Life Sciences, Regulatory Science, Quality Assurance, or a related field.
Advanced degree preferred.
Required Skills
5+ years of regulatory submission publishing experience in diagnostics or related life sciences.
Regulatory dossier preparation, publishing, validation, and electronic submission.
FDA, EMA, and ICH regulatory requirements.
Diagnostic and life sciences regulatory submissions, including 510(k), PMA, BLA, IND, IDE, and IVDR.
Regulatory submission quality control (QC), validation report review, and publishing issue resolution.
Submission lifecycle management, sequence planning, document traceability, and archiving.
Regulatory document management and submission readiness.
Preferred Skills
Veeva Vault, Veeva RIM, LORENZ docuBridge FIVE, or eCTD Xpress.
FDA ESG, FDA CCP, EMA Common Gateway, and Notified Body submission portals.
Document Management Systems (DMS) and Content Management Systems (CMS).
AI, robotic process automation (RPA), and regulatory publishing automation tools.
Experience with global regulatory requirements beyond the US and EU.
Continuous process improvement, publishing workflow optimization, and leadership or mentoring experience.
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.