Senior​/Principal Regulatory Affairs Specialist, Medical Device

Senior / Principal Regulatory Affairs Specialist, Medical Device

Direct hire W2 only Senior/Principal Regulatory Affairs Specialist – Med Device. No opportunity for c2c engagement on this role.

Our client is a privately held, innovation-driven Class III medical device company developing next‑generation laser and pulsed field ablation systems for atrial fibrillation. With multiple First‑In‑Human programs
, two active IDE clinical trials
, and a rapidly advancing pipeline of new catheter and capital system technologies, the organization is entering a high‑stakes phase that demands a more technically capable and strategically aligned Regulatory Affairs function.

The company is redefining Regulatory Affairs as a deeply technical, engineering‑integrated discipline rather than a documentation‑only function. Unlike traditional RA roles, this group is expected to actively participate in bench work, engineering discussions, clinical interfaces, and early drafting of submissions and responses.

• Act as a technical regulatory partner
  , collaborating closely 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 (
  FDA Class II/III, EU MDR Class I/IIb/III
  ).
• 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.
• Serve as a key participant 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 insight on design decisions, risk management, test standards, and manufacturing changes.
• Support labeling/UDI, lifecycle management, and global post‑market requirements.
• Establish strong onsite presence to evaluate issues directly and report back to remote leadership.
• Work effectively in a high‑energy, high‑growth, multi‑project environment with frequent shifts in priorities.
• Help evolve internal procedures, templates, documentation practices, and regulatory standards.

• BS in Science or Engineering with technical medical‑device experience or background.
• 5–7 years of regulatory experience in medical devices (EP or cardiology strongly preferred).
• Direct, hands‑on experience with FDA Class II & III submissions and EU MDR Class I/IIb/III.
• Experience with FDA submission systems, EUDAMED, Authorized Reps, and Importers.
• Demonstrated 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 complex engineering data (software, electrical schematics, mechanical systems) into clear regulatory narratives.
• Strong written and verbal technical communication skills.
• Skilled in MS Office Suite and Adobe Pro (advanced features).
• Highly organized with strong ability to manage multiple deadlines in a fast‑paced environment.
• Capable of anticipating regulatory needs and guiding teams with sound regulatory judgment.

• Experience in startup or small, fast‑moving environments.
• Clinical exposure – ability to support clinical documentation and interactions with Notified Bodies.
• Familiarity with IEC standards, sterilization, biocompatibility, labeling requirements.
• Experience reviewing promotional literature for compliance.
• PMDA (Japan) or additional global regulatory experience.

Strong preference for candidates based in or near Marlborough, MA.

Competitive and aligned with experience and seniority level.

• Seniority level:
  Mid‑Senior level
• Employment type:
  
  Full‑time
• Job function:
  Engineering and Strategy/Planning
• Industries:
  Medical Equipment Manufacturing