PMA
PMA (Premarket Approval) is the highest level of approval required by the FDA for medical devices. When you see this on a resume, it refers to experience with the complex process of getting new medical devices approved for sale in the United States. This is different from the simpler 510(k) process, and is required for high-risk or new types of medical devices. Professionals who work with PMAs help prepare extensive documentation, manage clinical trials, and ensure compliance with FDA requirements. It's like getting a very thorough safety check and permission slip before a new medical device can be sold to hospitals or patients.
Examples in Resumes
Led team in successful submission of PMA application for Class III cardiovascular device
Managed clinical trials and documentation for PMA submission process
Coordinated with FDA reviewers during PMA review cycles
Prepared and maintained Premarket Approval documentation for surgical devices
Typical job title: "Regulatory Affairs Specialists"
Also try searching for:
Where to Find Regulatory Affairs Specialists
Professional Organizations
Online Resources
Job Resources
Example Interview Questions
Senior Level Questions
Q: How would you manage a PMA submission that receives major deficiencies from the FDA?
Expected Answer: Should discuss experience with FDA communications, ability to coordinate cross-functional teams, strategic planning for addressing deficiencies, and knowledge of how to prepare and submit amendments to the FDA.
Q: What strategies would you use to reduce the timeline for a PMA approval process?
Expected Answer: Should demonstrate knowledge of pre-submission meetings, strategic planning of clinical trials, efficient documentation practices, and understanding of FDA review cycles and interaction opportunities.
Mid Level Questions
Q: What are the key differences between a PMA and a 510(k) submission?
Expected Answer: Should explain that PMAs are for high-risk devices requiring clinical trials and more extensive safety proof, while 510(k)s are for devices similar to existing ones, requiring less extensive documentation.
Q: What types of documentation are required in a PMA submission?
Expected Answer: Should mention clinical trial results, manufacturing processes, quality system documentation, device safety and effectiveness data, and labeling requirements.
Junior Level Questions
Q: What is a PMA and why is it important?
Expected Answer: Should explain that PMA is the FDA's strictest device review process, required for new and high-risk medical devices to prove they're safe and effective before market release.
Q: What role does clinical data play in a PMA submission?
Expected Answer: Should understand that clinical trials are required to prove device safety and effectiveness, and be able to explain basic requirements for clinical data collection.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of FDA regulations
- Document control and organization
- Assistance with PMA submission preparation
- Quality system documentation
Mid (2-5 years)
- Managing PMA documentation
- Clinical trial coordination
- FDA communication support
- Regulatory submission preparation
Senior (5+ years)
- Full PMA submission management
- FDA negotiation strategy
- Clinical trial design oversight
- Regulatory team leadership
Red Flags to Watch For
- No knowledge of FDA regulations
- Unfamiliarity with clinical trial requirements
- Lack of experience with regulatory documentation
- Poor understanding of quality system requirements
- No experience with FDA communications
