JenaValve Technology, Inc.
Project Manager, Regulatory Affairs
JenaValve Technology, Inc., Irvine, California, United States, 92713
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Project Manager, Regulatory Affairs
role at
JenaValve Technology, Inc.
3 days ago Be among the first 25 applicants
Description Job Title:
Project Manager, Regulatory Affairs
Supervisor/Manager Title:
Director, Regulatory Affairs
Job Description Summary:
Responsible for the timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clinical, pre-, and post-market applications), query responses, and correspondence tracking. Maintains regulatory information for competitive intelligence, literature maintenance, and standards review programs. Interacts with internal departments and external representatives (distributors, legal agents, regulatory agencies). Provides expertise in translating regulatory requirements into practical strategies and planning documents. Supports serious adverse event reporting and post-market surveillance activities. Performs other projects and duties as assigned.
Job 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, providing clear regulatory strategies for product development and quality projects.
Collaborate with stakeholders to develop technical, clinical, or labeling content to support company objectives and regulatory submissions.
Provide coaching and support to regulatory department members.
Communicate with regulatory bodies, legal agents, distributors, and suppliers to ensure regulatory approvals.
Review document change orders for impact on filings.
Manage standards review and interpret regulatory requirements for products and procedures.
Support adverse event reporting, MDRs, Vigilance reports, and communication with authorities.
Review and approve technical documents like FMEAs, protocols, reports, NCRs, CAPAs.
Participate in audits as needed.
Update departmental procedures.
Perform other duties as assigned.
Qualifications
Bachelor’s degree in a scientific discipline or equivalent.
5-8 years in medical device Regulatory Affairs.
Experience with US Class III cardiovascular devices and EU MDR preferred.
Knowledge of quality systems and global regulations.
Ability to interpret standards and guide project teams.
Ability to work in a fast-paced environment, self-motivated, disciplined.
Strong communication, technical writing, and organizational skills.
Skills and Abilities
Excellent communication, organization, and project management skills.
Problem-solving and analytical skills.
Self-directed with minimal routine instruction.
Adaptability to shifting priorities.
Diplomacy and cultural sensitivity.
Proficiency in Microsoft Office.
Ability to occasionally lift up to 20 pounds.
Additional Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Project Management and IT
Industry: Medical Equipment Manufacturing
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Project Manager, Regulatory Affairs
role at
JenaValve Technology, Inc.
3 days ago Be among the first 25 applicants
Description Job Title:
Project Manager, Regulatory Affairs
Supervisor/Manager Title:
Director, Regulatory Affairs
Job Description Summary:
Responsible for the timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clinical, pre-, and post-market applications), query responses, and correspondence tracking. Maintains regulatory information for competitive intelligence, literature maintenance, and standards review programs. Interacts with internal departments and external representatives (distributors, legal agents, regulatory agencies). Provides expertise in translating regulatory requirements into practical strategies and planning documents. Supports serious adverse event reporting and post-market surveillance activities. Performs other projects and duties as assigned.
Job 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, providing clear regulatory strategies for product development and quality projects.
Collaborate with stakeholders to develop technical, clinical, or labeling content to support company objectives and regulatory submissions.
Provide coaching and support to regulatory department members.
Communicate with regulatory bodies, legal agents, distributors, and suppliers to ensure regulatory approvals.
Review document change orders for impact on filings.
Manage standards review and interpret regulatory requirements for products and procedures.
Support adverse event reporting, MDRs, Vigilance reports, and communication with authorities.
Review and approve technical documents like FMEAs, protocols, reports, NCRs, CAPAs.
Participate in audits as needed.
Update departmental procedures.
Perform other duties as assigned.
Qualifications
Bachelor’s degree in a scientific discipline or equivalent.
5-8 years in medical device Regulatory Affairs.
Experience with US Class III cardiovascular devices and EU MDR preferred.
Knowledge of quality systems and global regulations.
Ability to interpret standards and guide project teams.
Ability to work in a fast-paced environment, self-motivated, disciplined.
Strong communication, technical writing, and organizational skills.
Skills and Abilities
Excellent communication, organization, and project management skills.
Problem-solving and analytical skills.
Self-directed with minimal routine instruction.
Adaptability to shifting priorities.
Diplomacy and cultural sensitivity.
Proficiency in Microsoft Office.
Ability to occasionally lift up to 20 pounds.
Additional Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Project Management and IT
Industry: Medical Equipment Manufacturing
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