Project Manager
Veracyte, Inc.
PMP
Senior Regulatory Affairs Specialist
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $92,000 - $138,000 per year
Job Level
Senior
About the role
- Sustain current product portfolio and ensure compliance with US and EU regulatory requirements
- Review design and product changes to ensure regulatory requirements continue to be met and document "no file" decisions
- Review promotional and advertising materials for compliance
- Submit product changes and annual reports and ensure technical documentation is current and accurate
- Provide strategic input and technical guidance on regulatory requirements for product modifications
- Prepare Pre-Sub, IDE/IDE Supplement, PMA/PMA Supplement, and 510(k) submissions and technical documents to support CE mark/MDR submissions
- Manage multiple projects, prioritize tasks, and meet project schedules
- Interface with engineering, quality, clinical, marketing, and other functions to fulfill regulatory responsibilities
- Communicate with regulatory agencies and Notified Bodies and serve as regulatory liaison for project teams throughout the product lifecycle
- Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
- Create or revise departmental procedures to improve operations or reflect changing regulatory requirements
- Participate in internal and external audits and maintain regulatory affairs documentation to support compliance
- Perform other duties as assigned or required
Requirements
- Bachelor’s degree in Science or Engineering (or related field) from an accredited college or university required
- Minimum of 4 years of relevant experience in medical device regulatory affairs (or advanced degree with minimum 2 years of experience)
- Proven history of successful 510(k) submissions or experience supporting US 510(k) filings
- Solid experience or knowledge of EU MDR requirements and submissions
- Excellent technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology
- Experience preparing Pre-Sub, IDE/IDE Supplement, PMA/PMA Supplement, and 510(k) submissions (preferred)
- Experience supporting CE mark/MDR submissions (preferred)
- Proficiency with Microsoft Office and relevant software tools
- Excellent written and oral communication, technical writing, and editing skills
- Strong attention to detail with ability to manage multiple projects and changing priorities
- Ability to effectively communicate and interface with cross-functional project teams
- RAPS Professional Certification (RAC) - nice to have
- History of successful IDE and PMA submissions and other worldwide submissions and clearances - nice to have
- Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards - nice to have
- Excellent leadership, interpersonal, and influencing skills - nice to have
- This is not a remote position; onsite at UCI facility with a minimum of 4 days onsite per week
- Ability to perform essential physical job functions, interact with a computer, and comply with hospital credentialing where applicable
