Note: The job is a remote job and is open to candidates in USA. JenaValve Technology, Inc. is a company focused on regulatory affairs within the medical device industry. The Project Manager, Regulatory Affairs, will be responsible for the preparation and submission of global regulatory affairs submissions, maintaining regulatory information, and interacting with internal and external stakeholders to ensure compliance with regulatory requirements.
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
Skills
- 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
- Ability to travel up to 20%
- Experience with US Class III cardiovascular devices preferred
- Experience with EU MDR implementation preferred
Company Overview
Company H1B Sponsorship