Regulatory Affairs Manager

T45 Labs•Santa Clara, CA

22h•Remote

About The Position

VahatiCor is a venture-backed medical technology company developing a cardiovascular therapy and building the regulatory systems and infrastructure needed for its next stage. The Regulatory Affairs Manager will develop and maintain regulatory strategies and manage submission activities for cardiovascular device programs. This hands-on role emphasizes investigational clinical programs and preparation for Premarket Approval (PMA). The manager will prepare and coordinate regulatory filings, maintain regulatory records, and coordinate with regulatory agencies and external regulatory specialists. The role collaborates with R&D, Clinical, Quality, and Manufacturing to ensure development activities, clinical evidence, and supporting documentation meet regulatory requirements and submission objectives. The position is remote and reports to the Chief Human Resources Officer. Travel to VahatiCor’s headquarters in Santa Clara, California, is expected for in-person meetings and activities, and international travel may also be required. The anticipated hiring range is $129,000–$152,000; compensation depends on experience, qualifications, geographic location, and other job-related factors. Total compensation may also include bonus opportunities, equity, and company-sponsored benefits. Candidates must be permanently authorized to work in the United States without current or future visa sponsorship. VahatiCor is an Equal Opportunity Employer and is committed to an inclusive workplace. Employment decisions are based on qualifications, merit, and business needs.

Requirements

Bachelor’s degree in chemistry, pharmacy, life sciences, engineering, or a related scientific discipline.
Minimum of five years of regulatory affairs experience.
Medical device regulatory experience, including direct preparation and coordination of FDA submissions.
Experience supporting Class III medical device programs and investigational clinical studies.
Experience preparing or managing substantial portions of a PMA submission.
Working knowledge of US medical device requirements and applicable European regulatory requirements.
Ability to evaluate complex technical and clinical information and prepare clear, accurate regulatory documents.
Strong organization, attention to detail, and ability to manage multiple priorities and submission deadlines.
Clear written and verbal communication skills and demonstrated ability to collaborate across departments.
Ability to work independently, adapt to changing priorities, and exercise sound judgment in a growing company.
Permanently authorized to work in the United States without current or future visa sponsorship.

Nice To Haves

Experience with catheter-based cardiovascular devices.
Experience in an early-stage or venture-backed medical device company.
Experience coordinating FDA meetings and responding to agency questions.
Experience supporting European clinical investigations and working with European Authorized Representatives or external regulatory specialists.
Regulatory Affairs Certification (RAC).

Responsibilities

Develop and maintain US and international regulatory strategies aligned with product development, clinical study, and commercialization objectives.
Work with leadership and external regulatory specialists to establish submission pathways, evidence requirements, filing plans, and agency interactions.
Translate regulatory requirements into practical plans with deliverables, responsibilities, timelines, and dependencies.
Identify gaps in technical and clinical documentation and coordinate actions to address them before submission.
Evaluate regulatory issues affecting product approvals and recommend actions supporting company objectives.
Maintain current knowledge of FDA, European, and other applicable regulatory requirements, policies, and guidance.
Prepare and coordinate FDA submissions, including IDE applications and amendments, PMA applications and related submissions, clinical progress reports, and other required filings.
Manage PMA preparation, including planning, content development, contributor coordination, document review, and application assembly.
Coordinate technical, preclinical, clinical, manufacturing, and quality information for regulatory submissions.
Review submissions for accuracy, completeness, consistency, and alignment with supporting evidence.
Establish submission schedules and track document completion, internal reviews, approvals, and outstanding issues.
Coordinate responses to agency questions and requests for additional information, with appropriate supporting documentation.
Track submission status, response deadlines, approval conditions, and regulatory commitments.
Collaborate with Clinical Affairs on regulatory requirements for investigational device studies in the United States and applicable international markets.
Prepare and coordinate clinical study submissions, amendments, progress reports, and required safety reporting with responsible teams.
Coordinate regulatory reporting of unanticipated adverse device effects and other reportable events, as applicable.
Review study documentation for consistency with regulatory authorizations, device information, and agency commitments.
Track reporting obligations and approval conditions associated with clinical investigations.
Coordinate regulatory activities supporting US and European study sites.
Serve as a key company regulatory contact for US activities within established company approvals.
Develop and maintain relationships with regulatory agencies, external regulatory specialists, industry groups, and business partners.
Coordinate agency meeting preparation, including meeting requests, briefing materials, questions, and supporting documentation.
Document agency feedback and translate commitments into assigned actions and follow-up activities.
Coordinate reports and documentation for the European Authorized Representative, as applicable.
Manage assigned consultant deliverables, timelines, document reviews, and follow-up activities.
Provide regulatory guidance to cross-functional teams during product planning, development, clinical evaluation, and commercialization preparation.
Collaborate with R&D and Quality to ensure development documentation and verification and validation evidence support submission requirements.
Assess regulatory implications of proposed changes to device design, materials, manufacturing processes, labeling, or intended use.
Coordinate change-assessment documentation and determine whether additional evidence or regulatory filings are required.
Review labeling and other assigned product materials for consistency with intended use, supporting evidence, and regulatory authorizations.
Collaborate with commercial and business development colleagues, as applicable, on regulatory considerations affecting product planning and launch.
Maintain organized regulatory submission files, agency correspondence, approvals, meeting records, and reporting documentation.
Maintain regulatory documentation, recordkeeping, and reporting to support inspection readiness.
Coordinate applicable establishment registration, device listing, and other regulatory maintenance activities.
Develop and maintain practical regulatory procedures, templates, and tracking tools.
Collaborate with Quality on regulatory records needed for inspections, audits, and external assessments.
Provide leadership with updates on submission progress, upcoming decisions, outstanding commitments, and regulatory risks.
Build effective working relationships across R&D, Clinical, Quality, Manufacturing, and other business functions.
Explain regulatory requirements clearly and help colleagues identify practical approaches to meeting them.
Establish responsibilities and review timelines for work involving multiple contributors.
Communicate concerns constructively, exercise sound judgment, and escalate unresolved issues when needed.
Follow commitments through completion and keep colleagues informed of progress and decisions.