Global Regulatory Affairs Senior Manager

Jenavalve Technology; Irvine (CA); On-site; USD 160,000 - 195,000; Full time

Job summary

Jenavalve Technology in Irvine, CA seeks a Sr. Manager, Regulatory Affairs to lead global regulatory strategy and submissions for medical devices.

Responsibilities include managing US and EU filings, coordinating cross-functional teams, and ensuring timely, scientifically valid submissions. This role oversees regulatory negotiations, responds to inquiries, and guides the organization through EU MDR transition.

Qualifications

• Bachelor’s degree in a scientific discipline (engineering, biology, etc.) or equivalent is required.
• Minimum of 7 to 10 years in medical device Regulatory Affairs.
• Minimum of 2 years of direct management experience.
• Experience with EU MDR implementation.
• Experience with US Class III, IDE submissions and/or PMA submissions.

Responsibilities

• Manage and oversee the preparation of high-quality US and EU filings for commercial and investigational device 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 to support company objectives and regulatory submissions.
• Provide coaching and support to direct report(s) and 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.
• Interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, clinical studies, testing, and record keeping.
• Review and approve marketing and promotional materials for compliance with labeling and regulatory requirements.
• 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.

Skills

Regulatory strategy

Regulatory submissions

Project management

Cross-functional collaboration

Regulatory writing

Quality systems

Education

Bachelor's degree in a scientific discipline

Job description

Jenavalve Technology in Irvine, CA seeks a Sr. Manager, Regulatory Affairs to lead global regulatory strategy and submissions for medical devices.

Responsibilities include managing US and EU filings, coordinating cross-functional teams, and ensuring timely, scientifically valid submissions. This role oversees regulatory negotiations, responds to inquiries, and guides the organization through EU MDR transition.