# Associate Director, Regulatory Affairs (IVD) at Precede Biosciences

- Company: Precede Biosciences
- What the company does: Backed by 5AM Ventures.
- Company website: https://precede.bio
- Type: Startups
- Level: Principal and up
- Location: Cambridge, MA
- Work setup: Hybrid
- Pay: $175K to $220K base salary per year (USD)
- Posted: 2026-10-07
- Apply by: 2026-11-21
- Apply: https://jobs.lever.co/precede/34aa9b38-b606-4903-9808-4f3a8532fcc2?utm_source=1752vc&utm_medium=careers
- Page: https://www.1752.vc/careers/jobs/precede-biosciences-associate-director-regulatory-affairs-ivd/

## About the role

This is a senior individual contributor role with broad influence across the organization. You will own submissions from strategy through approval, serve as the regulatory lead on cross-functional and partner teams, and translate complex analytical, clinical, software, and bioinformatics evidence into clear regulatory positions. The role is well suited to someone who combines sound judgment with the willingness and ability to draft the work directly. Found on 1752vc Careers, the job board for startup and VC roles.

## What they're looking for

- Bachelor's degree in life sciences, engineering, or a related field
- A minimum of 8 years of regulatory affairs experience in medical devices, including substantial experience with IVDs and increasing responsibility for regulatory strategy and submissions
- A demonstrated record of leading and authoring substantial portions of FDA IVD submissions. Direct experience with at least one major premarket pathway, such as 510(k), De Novo, or PMA, is required
- Strong knowledge of US and EU IVD requirements, design and development controls, risk management, and quality system expectations, with the ability to apply requirements to complex scientific and technical questions
- Experience with molecular diagnostics, NGS-based assays, or other complex diagnostics that combine laboratory processes, software, algorithms, and bioinformatics
- Ability to interpret analytical and clinical performance data and determine whether the evidence supports an intended use, claim, or regulatory position

Tags: Regulatory

Source: 1752vc Careers, https://www.1752.vc/careers/jobs/precede-biosciences-associate-director-regulatory-affairs-ivd/