Senior Regulatory Lead, IVD & Companion Diagnostics

Precede; Cambridge (MA); On-site; USD 175,000 - 220,000; Full time

Benefits offered by this job

Health benefits

Equity participation

Performance bonus

Job summary

Precede Biosciences in Cambridge, MA seeks an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our advanced diagnostics and companion programs, spanning FDA interactions to global submissions.

This senior individual contributor role emphasizes hands-on drafting, cross-functional collaboration, and a proactive regulatory lead for biopharma collaborations, with responsibility from strategy through approval.

Qualifications

• Lead regulatory strategy for US and global IVD workflows.
• Author and manage end-to-end regulatory submissions and responses.
• Represent regulators in meetings and translate feedback into plans.
• Guide companion diagnostic programs with cross-functional teams.

Responsibilities

• Develop and execute regulatory strategy from development through commercialization.
• Own submissions end to end: FDA 510(k), De Novo, PMA, IDEs, and international docs.
• Lead interactions with FDA and health authorities; prepare teams for meetings.
• Align diagnostics and therapeutic development plans with regulatory expectations.
• Define regulatory requirements for software and bioinformatics in regulated products.

Skills

Regulatory strategy

FDA submissions

IVD regulatory knowledge

Cross-functional leadership

Technical writing

Education

Bachelor's degree in life sciences/engineering

Job description

Precede Biosciences in Cambridge, MA seeks an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our advanced diagnostics and companion programs, spanning FDA interactions to global submissions.

This senior individual contributor role emphasizes hands-on drafting, cross-functional collaboration, and a proactive regulatory lead for biopharma collaborations, with responsibility from strategy through approval.