Project Manager, Regulatory Affairs

JENAVALVE TECHNOLOGY INC•Irvine, CA

2d•$130,000 - $140,000•Onsite

About The Position

Responsible for 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 (i.e., distributors, legal agents, regulatory agencies). Provides expertise in translating regulatory requirements into practical, workable strategy and planning documents. Provides counsel to project team members and regulatory affairs staff as applicable. Supports serious adverse event reporting, and completion of post-market surveillance activities (complaints, MDR and vigilance reports). Performs other projects and duties as assigned.

Requirements

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.

Nice To Haves

Experience with US Class III cardiovascular devices preferred.
Experience with EU MDR implementation preferred.

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.