We currently have an opening for a Senior Regulatory Affairs Specialist in our Pleasanton, CA location. In this role, you will perform regulatory affairs work assignments including analyses, evaluation, preparation, and submission of documentation for regulatory registration. You will support necessary regulatory activities required for product market entry and ensure procedures comply with regulatory agency specifications. This will require you to have knowledge of FDA, CA-FDB, and ISO regulations/standards.
- Assist in developing and deploying the Regulatory Program to ensure aggressive product approval and adoption within the international standard ISO13485; 21 CFR 803, 806, and 820; the current Canadian Medical Device Regulations (SOR 980282); Medical Device Directive 93/42/EEC (and all applicable amendments); and MHLW Ordinance No 169.
- Generate and coordinate regulatory submission documents for new products or changes to existing health authorities' filings.
- Write, submit, and coordinate new product notifications, CE Mark Technical Files/Dossiers, Investigational Device Exemptions (including reports and supplements), and international regulatory submissions in various countries.
- Review customer complaints for regulatory reportability.
- Review labeling and promotional materials for compliance with regulatory requirements.
- Review changes to existing products and documents to determine regulatory impact and define the requirements for regulatory submissions.
- Partner with various cross-functional teams throughout the organization (i.e. Marketing, Professional Education, Operations, R&D, Quality, etc.) on projects and other related tasks.
- Act as a team representative for promotional materials review, experimental designs, test protocols and reports, data analysis, and product labeling as related to registration and commercialization of NeoTract devices.
- Partner with the Clinical team to assure appropriate organization data are used for regulatory submissions and clinical presentations.
- Participate in research of regulatory issues and information and dissemination of regulatory information to all levels of the organization.
- Determine international regulatory requirements and develop plans to comply with national laws in each country.
- Perform other related duties and responsibilities as assigned.
- Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!