Regulatory Affairs Lead — Medical Device

About Us

Equitable is an MIT-founded medical technology company developing a groundbreaking smart capsule to make colorectal cancer screening
non-invasive, accessible, and affordable for everyone
.

With teams in
Boston
and
Kuala Lumpur
, we are building the world's first consumer-friendly platform for early cancer detection.

We are now looking for our
first Regulatory Affairs Lead
to guide our device through the FDA, CE, and MDA approval pathways and help shape the regulatory strategy that will define our global impact.

Role Summary

As the Regulatory Affairs Lead, you will be responsible for navigating the regulatory landscape for a novel Class II medical device (ingestible diagnostic capsule).

You will lead all regulatory submissions, risk documentation, quality management processes, and interactions with external testing labs, notified bodies, and regulators.

This is a high-ownership, strategic role where you will work directly with the founders and engineering team to take a first-in-category device from prototype to market.

Key Responsibilities

Regulatory Strategy & Planning

• Develop and lead the regulatory strategy for U.S. FDA (510(k) or De Novo), CE-marking, and Malaysian MDA approvals.
• Map out regulatory pathways for a novel ingestible diagnostic device (hardware + software + data).
• Identify predicate devices or justify De Novo submission (if needed).

Documentation & Submissions

• Own the preparation of all regulatory submissions, including:
• Technical File / Design Dossier
• FDA pre-subs, 510(k), or De Novo packages
• Risk management file (ISO 14971)
• Biocompatibility documentation (ISO 10993)
• Clinical evaluation reports (CER)
• Software validation documentation (IEC 62304)
• Electrical & safety testing documentation (IEC 60601)

Quality & Compliance

• Set up and maintain a compliant
  Quality Management System (QMS)
  aligned with
  ISO 13485
  .
• Work with engineering to ensure design controls, verification/validation, and traceability are in place.
• Oversee usability engineering processes (IEC

Testing & External Coordination

• Coordinate with external labs for:
• biocompatibility testing
• electrical and mechanical safety testing
• wireless/RF compliance
• sterilization and packaging validation
• Manage communication with Notified Bodies (EU), FDA reviewers (US), and MDA (Malaysia).

Clinical & Post-Market Support

• Support design of clinical validation studies.
• Prepare documentation for ethics boards and clinical protocols.
• Ensure ongoing compliance with post-market surveillance requirements.

What We're Looking For

Required

• 3–10+ years of regulatory experience in medical devices
• Strong familiarity with
  FDA
  ,
  CE
  , and
  ISO 13485
  regulatory frameworks
• Experience with
  diagnostic devices, endoscopy, or combined hardware–software devices
• Hands-on experience preparing and submitting regulatory dossiers
• Deep working knowledge of
  ISO 14971
  ,
  IEC 60601
  ,
  IEC 62304
  ,
  IEC 62366
  , and
  ISO 10993
• Strong documentation skills and attention to detail
• Ability to work cross-functionally with engineering, clinical, and leadership teams
• Comfortable working in a high-velocity startup environment

Bonus

• Experience with ingestible devices or gastrointestinal medical devices
• Background in biomedical engineering, regulatory science, or clinical research
• Prior experience in a startup or rapid R&D environment
• Familiarity with AI/ML-related regulatory guidance (if applicable)

What We Offer

• Competitive, above-market compensation
• Opportunity to define the regulatory pathway for a first-in-category device
• Direct impact on global public health and cancer prevention
• Close collaboration with a world-class advisory board (MIT, Harvard, FDA)
• Fast-moving, mission-driven culture
• Role progression into Head of Regulatory as we scale

How to Apply

Send your CV, portfolio of regulatory submissions, or a brief note about your experience to:

Or message us directly on LinkedIn