About Pearl
Pearl is shaping the future of dentistry with a suite of AI solutions developed to establish higher standards of quality and care for patients worldwide. Since 2019, our team has engineered FDA-cleared computer vision capabilities for interpretation of 2D and 3D dental imagery — industry-leading capabilities which clinicians, practice owners, labs and insurers use to elevate the efficiency, accuracy and consistency of dental care around the world.
Who We’re Looking For
We are seeking a highly skilled and experienced Technical Regulatory Writer to join our team. The ideal candidate will have extensive experience with FDA regulations and preferably experience with the EU Medical Device Regulation (MDR). This role is critical in ensuring that our documentation complies with global regulatory standards and supports our mission of advancing healthcare through innovation.
Regulatory Document Preparation:
- Author, review, and manage a variety of regulatory documents including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post-Market Clinical Follow-up (PMCF) Plans.
- Develop and maintain regulatory submissions to ensure compliance with FDA and MDR requirements
Collaboration and Communication:
- Collaborate with cross-functional teams including clinical research, product management, and regulatory affairs to gather necessary information and ensure the accuracy of documentation.
- Communicate effectively with stakeholders to address regulatory queries and provide updates on submission statuses.
Research and Analysis:
- Conduct comprehensive literature reviews and data analyses to support clinical study designs and regulatory submissions.
- Stay updated on regulatory guidelines and best practices to ensure all documents meet the latest standards.
Project Management:
- Manage timelines and deliverables for regulatory documentation projects, ensuring timely completion and submission.
- Coordinate with external partners such as contract research organizations (CROs) to facilitate the development and review of regulatory documents.
What You’ll Need to Succeed:
- Bachelor’s degree in a life sciences, biomedical, or related field (Master’s preferred).
- Minimum of 3 years of experience in regulatory writing, specifically with FDA regulations.
- Experience with MDR and EU regulatory submissions is highly preferred.
- Proven track record of successful regulatory submissions for medical devices.
- Strong understanding of scientific research methodologies and medical device regulations (FDA 21 CFR 812, EU MDR 2017/745).
- Proficiency in document development software (Microsoft Word, Excel, PowerPoint).
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple projects and work effectively under tight deadlines.
What We Offer
- Competitive Benefit and Compensation Offerings
- Ongoing Training and Development Opportunities
- Unaccrued, Flexible PTO
- Remote Work