JenaValve Technology, Inc. · 15 hours ago
Project Manager, Regulatory Affairs
Irvine, CA
Full-time
Onsite
Senior Level
5+ years expJenaValve Technology, Inc. is focused on regulatory affairs for medical devices, and they are seeking a Project Manager to oversee global regulatory submissions and maintain compliance. The role involves preparing documentation, collaborating with stakeholders, and ensuring regulatory approvals are met for product development and quality projects.
Health CareManufacturingMedical Device
Responsibilities
Prepare timely, high-quality, technical documentation and regulatory submissions for investigational device applications, commercial registrations, annual reports, and amendments/supplements
Serve as a regulatory team member of product development and sustaining teams, providing clear, concise regulatory strategy to ensure applicable global requirements are met for product development and quality system projects
Collaborate with key stakeholders to develop technical, clinical, or labeling content (including Clinical Operations, Marketing, R&D, Manufacturing and Quality) to support company objectives and regulatory submissions
Provide coaching and support to other members of the regulatory department
Communicate with regulatory bodies, legal agents, distributor partners, and suppliers on project-related activities necessary to ensure appropriate regulatory approvals are in place in covered regions
Review document change orders for impact on US, EU and international regulatory filings per standard procedures
Manage standards review process and assist company SME’s to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, clinical studies, testing, and record keeping
Support serious adverse event reporting process, Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication with regulatory authorities and external stakeholders
Review and approve FMEAs/risk analyses, protocols, reports, NCRs, CAPAs, and other technical documents
Participate in internal audits and external audits as needed
Update and maintain departmental procedures as required
Perform other duties as assigned
Qualification
Required
Bachelor's degree in a scientific discipline (engineering, biology, etc.) or equivalent is required
Minimum of 5 to 8 years in medical device Regulatory Affairs
Comprehensive knowledge of quality systems and relationship to business
Experience in applying global medical device regulations and product development process
Ability to interpret regulatory standards and guidance and provide direction to project teams
Ability to work in a fast-paced, technically challenging environment where drive is critical to success
Self-motivated and self-disciplined; able to prioritize multiple tasks and responsibilities
Effective interpersonal skills/diplomacy and problem-solving techniques
Excellent applied thinking and technical writing skills
Strong communication and organization skills required
Strong verbal and written communication, organization, and project management skills required
Works on problems of diverse scope and analyzes data and information to make sound decisions, recommendations, and regulatory filings of high quality
Self-directed with minimum instruction on routine work, and general instruction on new assignments
Ability to handle challenges and uncertain circumstances, with adaptability to shifting company priorities
Exercises good judgment within generally defined practices and policies in all aspects of the job
Diplomacy and cultural sensitivity are essential attributes
Software proficiency in Microsoft Office Suite
The employee must occasionally lift and/or move up to 20 pounds
Preferred
Experience with US Class III cardiovascular devices preferred
Experience with EU MDR implementation preferred
Company
JenaValve Technology, Inc.
JenaValve is a medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of aortic regurgitation (AR).
51-200 employees
H1B Sponsorship
JenaValve Technology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (3)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$341.57MKey Investors
Bain Capital Life SciencesRMMFraunhofer Venture
2024-07-24Acquired
2022-08-31Series C· $100M
2022-01-04Series Unknown· $8M
Leadership Team
John Kilcoyne
CEO
Kari-Lyn Moore
Chief Financial Officer
Recent News
2026-01-11
2026-01-11
Company data provided by crunchbase