Senior​/Principal Regulatory Affairs Specialist

Description

Onsite in Marlborough, MA

Our client is a privately held Class III medical device organization developing laser and pulsed field ablation systems for atrial fibrillation. The regulatory function integrates with engineering and clinical teams and contributes to bench work, design discussions, and early drafting of submissions. The role supports two IDE programs, accelerates global submissions, strengthens Notified Body interactions, and provides an onsite regulatory presence in a fast-paced, multi-project environment.

This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis.

Salary: $110,000 - $140,000/ yr. w2

• Act as a technical regulatory partner collaborating with engineering, R&D, manufacturing, and clinical teams.
• Develop and execute regulatory strategies for pivotal trials, IDE expansions, and commercialization pathways.
• Lead or contribute to global submissions for FDA Class II/III and EU MDR Class I/IIb/III devices.
• Prepare, collect, evaluate, and synthesize technical documentation, engineering data, clinical data, and test results.
• Draft first and second versions of submission content and regulatory responses.
• Participate in engineering meetings, bench activities, and clinical review discussions.
• Support and prepare for FDA, EU Notified Body, and partner audits.
• Ensure alignment with FDA, EU MDR, EUDAMED, and global regulatory requirements.
• Provide regulatory input on design decisions, risk management, test standards, and manufacturing changes.
• Support labeling and UDI, lifecycle management, and global post-market requirements.
• Establish a strong onsite presence to evaluate issues and report to remote leadership.
• Operate effectively in a high-growth, multi-project environment with shifting priorities.
• Help evolve internal procedures, templates, documentation practices, and regulatory standards.

• 5–7 years of regulatory experience in medical devices, with electrophysiology or cardiology preferred.
• Direct, hands-on experience with FDA Class II and III submissions and EU MDR Class I/IIb/III.
• Experience with FDA submission systems, EUDAMED, Authorized Representatives, and Importers.
• Proven success supporting FDA and Notified Body audits.
• Ability to interpret and apply test standards and technical requirements.
• Experience writing initial drafts of submissions, responses, and regulatory documentation.
• Ability to translate software, electrical, and mechanical engineering data into clear regulatory narratives.
• Strong written and verbal technical communication skills.
• Proficiency with MS Office Suite and Adobe Pro.
• High organization and ability to manage multiple deadlines in a fast-paced environment.
• Ability to anticipate regulatory needs and guide teams with sound judgment.
• Nice to have:
  Class III cardiac, electrophysiology, or ablation device experience.
• Nice to have:
  Startup or small-company experience.
• Nice to have:
  Clinical exposure supporting documentation and Notified Body interactions.
• Nice to have:
  Familiarity with IEC standards, sterilization, biocompatibility, and labeling requirements.
• Nice to have:
  Experience reviewing promotional literature for compliance.
• Nice to have: PMDA or additional global regulatory experience.

• BS in Science or Engineering.