Job Summary
We are seeking a highly motivated FDA SaMD (Software as a Medical Device) Regulatory Affairs Consultant to join our team as a 1099 contractor. In this dynamic role, you will provide expert guidance on regulatory pathways, focusing on Pre-Sub and Informal Inquiry processes with the U.S. Food and Drug Administration (FDA). Your expertise will help accelerate the development and approval of innovative SaMD products, ensuring compliance with all relevant regulations and standards. This position offers an exciting opportunity to influence cutting-edge health technology through strategic regulatory planning and clear communication with regulatory agencies.
Duties
- Lead and prepare FDA Pre-Submission (Pre-Sub) meetings, including drafting briefing documents, questions, and responses to facilitate productive discussions with regulators.
- Develop and execute strategies for Informal Inquiries to obtain early feedback on regulatory pathways, device classification, and submission requirements.
- Review and interpret FDA regulations, guidance documents, ICH guidelines, EMA regulations, and ISO standards relevant to SaMD products.
- Collaborate with cross-functional teams—including clinical trials, quality assurance, research, and product development—to ensure regulatory compliance throughout the product lifecycle.
- Manage regulatory compliance documentation, including regulatory submissions such as 510(k), De Novo requests, or other premarket notifications or approvals.
- Conduct regulatory compliance analysis related to chemistry, manufacturing & controls (CMC), risk management, and biomedical regulations to support product development strategies.
- Maintain up-to-date knowledge of health regulation policies globally to advise on international compliance requirements and align strategies accordingly.
- Utilize compliance management software for tracking submissions, deadlines, and project milestones related to regulatory affairs projects.
- Support project management efforts by coordinating activities across teams to meet regulatory timelines efficiently while ensuring quality standards are upheld.
Skills
- Extensive knowledge of FDA regulations governing SaMD products, drug regulation processes, and health regulation policy frameworks.
- Strong understanding of clinical trial design, data analysis skills, and research methodologies pertinent to medical device development.
- Proven experience in regulatory compliance management within pharmaceutical or biomedical sectors.
- Expertise in preparing regulatory submissions including FDA pre-submission packages and informal inquiries with clear articulation of technical data.
- Excellent project management skills with the ability to coordinate multiple stakeholders across cross-functional teams effectively.
- Proficiency with compliance management software tools for document tracking and project organization.
- Familiarity with ISO standards relevant to medical devices or pharmaceuticals; knowledge of ICH guidelines is a plus.
- Exceptional writing skills for preparing detailed reports, briefing documents, and correspondence with regulatory agencies.
- Ability to analyze complex data sets related to drug regulation, quality assurance processes, and risk management strategies.
- Strong communication skills for engaging with internal teams and external regulators confidently while maintaining transparency.
Join us in shaping the future of digital health solutions! This role offers an engaging environment where your expertise directly impacts innovative medical technologies that improve lives worldwide. If you’re passionate about navigating complex regulations with clarity and precision while driving strategic initiatives forward—apply today!
Pay: From $150.00 per hour
Work Location: Remote
