Manager, Regulatory Affairs (International)

JENAVALVE TECHNOLOGY INC•Irvine, CA

2d•$150,000 - $150,000•Onsite

About The Position

Manages global regulatory affairs communication, filing strategy, submission development, regulatory negotiation, and query response development for JenaValve with focus on transcatheter heart valve system devices. Serve as subject matter expert for OUS geographies. Provides expertise in translating regulatory requirements into practical, workable strategy and planning documents. Ensures timely preparation of organized and scientifically valid submissions based on needs of internal and external stakeholders. Collaborate with JenaValve’s cross-functional departments to achieve corporate objectives. Interacts directly with external representatives (i.e., regulatory agencies, suppliers, distributors). Leads and develops direct report(s).

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.
Demonstrated track record of people management.
Expert knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices.
Comprehensive knowledge of quality systems including MDSAP.
Experience in applying global medical device regulations and product development process.
Ability to interpret regulatory standards and guidance documents and provide direction to project teams.
Strong verbal and written communication, organization, and project management skills required, including the ability to influence and to work effectively cross-culturally and cross-functionally.
Works on problems of diverse scopes and analyzes data and information to make sound decisions, recommendations, and regulatory filings of high quality.
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.
Exercises good judgment within generally defined practices and policies in all aspects of the job.
Normally receives no instruction on routine work, and general instructions on new assignments.

Responsibilities

Manage and oversee the preparation of high-quality global filings for commercial and investigational device registrations, annual reports, and amendments/supplements.
Manage rest of world (all geographies outside the US & EU).
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 R&D, Clinical, Marketing, Manufacturing and Quality) 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 per standard procedures.
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.
May anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory compliance.
Review and approve marketing and promotional materials for compliance with labeling and regulatory requirements for the appropriate market.
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 to support expansion into new markets.
Perform other duties as assigned.