Senior Regulatory Affairs Lead, IVD Diagnostics

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

Benefits offered by this job

Performance bonus

Equity participation

Health benefits

Job summary

Precede Biosciences, Inc. in Cambridge, MA seeks an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs.

This senior role owns submissions from strategy through approval and serves as the regulatory lead on cross-functional and partner teams. The role requires leading FDA interactions, coordinating US and global IVD submissions (510(k), De Novo, PMA), and guiding diagnostic development with biopharma partners.

Qualifications

• Bachelor's degree in life sciences, engineering, or a related field.
• 8+ years of regulatory affairs experience in medical devices, including substantial experience with IVDs.
• Proven record of leading and authoring substantial portions of FDA IVD submissions. Direct experience with at least one major premarket pathway (510(k), De Novo, PMA).
• Strong knowledge of US and EU IVD requirements, design and development controls, risk management, and quality system expectations.
• Experience with molecular diagnostics, NGS-based assays, or other complex diagnostics with software, algorithms, and bioinformatics.
• Ability to interpret analytical and clinical performance data to support an intended use or regulatory position.
• Excellent technical writing and communication skills for regulators, partners, scientists, and senior leaders.
• Sound judgment and comfort operating in a growth-stage environment, balancing strategic direction with hands-on execution.

Responsibilities

• Lead regulatory strategy for US and global IVD submissions from development through commercialization.
• Own submissions end to end, including FDA Pre-Submissions, IDEs, 510(k)s, De Novo, PMAs and international documentation.
• Represent Precede with regulators; prepare teams for meetings and convert agency feedback into clear decisions and development plans.
• Guide companion diagnostic programs with biopharma collaborations and align diagnostic and therapeutic development plans.
• Define analytical and clinical performance studies to support intended use and claims.
• Assess changes and communications for regulatory impact and review claims for compliance.
• Manage regulatory risk by interpreting evolving requirements and recommending practical paths.

Skills

Regulatory strategy

FDA submissions

IVD requirements

Medical devices

Technical writing

Cross-functional leadership

Bioinformatics

Regulatory risk management

Education

Bachelor's degree

Job description

Precede Biosciences, Inc. in Cambridge, MA seeks an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs.

This senior role owns submissions from strategy through approval and serves as the regulatory lead on cross-functional and partner teams. The role requires leading FDA interactions, coordinating US and global IVD submissions (510(k), De Novo, PMA), and guiding diagnostic development with biopharma partners.