An exciting Peripheral Vascular Start up in Menlo Park just achieved their 510K approval and need to add a second Regulatory expert to their team. As a senior professional in the field, this person will partner with the VP of RA/QA to effectively drive regulatory submissions by delivering accurate, timely, and high quality regulatory documents, and projects in accordance with company objectives, policies and procedures. This role provides regulatory guidance on ongoing cross-functional projects to ensure compliance with FDA.

Responsibilities:

• Participate in development of and execute on regulatory strategy and priorities in alignment with company’s objectives and regulatory requirements.
• Drive regulatory support in cross-functional project teams to ensure regulatory guidelines are considered when setting deliverables, creating timelines and allocating resources.
• Review and approve Documents Change Order, CAPAs, NCRs, etc.
• Compile, prepare, review and submit high-quality regulatory submissions and filings such as Letter-To-File, 510(k), IDE, Design Dossier, Notified Body submissions and subsequent revisions/supplements and amendments, including all associated deliverables and timelines.
• Interact and negotiate directly with regulatory authorities during the product development and review process to facilitate submission approvals.
• Prepare various presentations to regulatory agency reviewers and/or inspectors as needed.
• Communicate effectively with internal stakeholders and regulatory authorities as required.
• Ensure compliance with FDA guidelines as well as company SOPs/protocols.
• Maintain regulatory files and tracking databases as required.
• Prepare and maintain annual licenses, US registrations/listings for assigned in a timely manner.
• Partner with Clinical Affairs to provide input and prepare critical data for physicians and proposals.

Minimum Requirements:

• Bachelor’s degree in related field and a minimum of 5 years of experience working in roles supporting medical devices; or an equivalent combination of education/training and experience.
• An advanced degree or RA Certification preferred
• Experience in the vascular space preferable.
• Proven ability preparing US Class II or III submissions
• Excellent written and oral communication skills with strong technical writing capabilities are a must.
• Demonstrated ability to meet deliverables through successful project/documentation management, and strong organizational skills.
• Ability to exercise independent judgment and decision making for complex situations/programs.
• Start up experience preferred

Salary Range: $120,000 – $150,000 annually