PMA Expert

PMA Expert

Location: Jersey City, NJ

Type: Direct Hire

Compensation: $150,000 – $170,000 annually

Work Model: Onsite, First Shift (9 AM – 5 PM)

Position Overview

We are seeking a highly accomplished PMA Expert with deep expertise in FDA-regulated medical devices , including PMA and 510(k) pathways. This executive-level leader will drive regulatory strategy, oversee all submission activities, and serve as the primary point of contact with FDA Medical Device divisions (CDRH). The ideal candidate thrives in a high-accountability, fast-paced environment where regulatory precision directly influences commercialization timelines and company growth.

Key Responsibilities

Executive Regulatory Leadership

• Develop and lead company-wide regulatory strategy for Class II & Class III medical devices
• Direct all PMA and 510(k) submission activities from concept through clearance/approval
• Serve as the primary liaison with FDA reviewers, including Medical Officers and branch leads
• Lead pre-sub meetings, deficiency responses, advisory panel interactions, and post-approval commitments
• Provide executive-level guidance on regulatory risk, clinical strategy, and submission pathways
• Align regulatory strategy with clinical, quality, manufacturing, and commercial teams
• Advise the CEO and executive team on regulatory timelines, risks, and investor-affecting milestones

Compliance & Oversight

• Ensure full compliance with 21 CFR Parts 803, 806, 807, 814, 820 and other relevant regulations
• Lead regulatory readiness for audits, inspections, and due diligence activities
• Build scalable regulatory processes to support rapid organizational growth

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field
  • Advanced degree (Master’s, RAC, JD) strongly preferred
• 10+ years of progressive FDA medical device regulatory leadership
• Proven executive ownership of successful PMA approvals and 510(k) clearances
• Extensive experience working directly with CDRH and FDA Medical Device reviewers
• Strong ability to participate in complex scientific and clinical discussions with FDA
• Demonstrated success presenting regulatory strategies to executives, boards, and investors
• Ability to operate autonomously in a small, high-growth environment

Leadership & Performance Attributes

• High personal accountability and strong work ethic
• Thrives in deadline-driven, high-pressure regulatory environments
• Executes with urgency, precision, and a “get-it-done” mindset
• Able to manage multiple critical priorities simultaneously
• Delivers accurate, well-structured submissions with quick turnaround

About System One

System One and its subsidiaries (Joulé, ALTA IT Services, Mountain Ltd.) are leaders in outsourced services and workforce solutions across North America. We offer eligible employees comprehensive benefits including medical, dental, vision, spending accounts, life and voluntary insurance plans, and 401(k) participation.

Equal Opportunity Employer: All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, veteran status, marital status, genetic information, or other protected characteristics.