Associate Director, Regulatory Affairs (IVD)

Precede Biosciences, Inc.; Cambridge (MA); Sur place; USD 175 000 - 220 000; Plein temps

Avantages offerts par ce poste

Performance bonus

Equity participation

Health benefits

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory strategy

FDA submissions

IVD requirements

Medical devices

Technical writing

Cross-functional leadership

Bioinformatics

Regulatory risk management

Formation

Bachelor's degree

Description du poste

The Opportunity

Precede Biosciences is seeking a hands-on Associate Director of Regulatory Affairs to lead regulatory strategy and execution for our products and companion diagnostic programs developed with biopharma partners. 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.

About Precede Biosciences

We are pioneering an advanced, minimally invasive, comprehensive epigenomics platform with the potential to profoundly impact the research and development of new medicines and the use of approved medicines in clinical practice across a number of conditions, including cancer. More information on our company and platform can be found on our company website and in our seminal publication in Nature Medicine.

We care deeply about creating a place where folks can do their best work from the start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.

What You Will Do

• Lead regulatory strategy. Develop and execute US and global IVD regulatory strategies from early development through commercialization, including pathway, intended use, claims, evidence, and sequencing of agency interactions.
• Own submissions end to end. A uthor, compile, and drive high-quality submissions and responses, including FDA Pre-Submissions, IDEs, 510(k)s, De Novo requests, PMAs and supplements, and relevant international technical documentation ( e.g. in support of IVDR CE ) .
• Represent Precede with regulators. Lead interactions with FDA and other health authorities or notified bodies, prepare teams for meetings, and convert agency feedback into clear decisions and development plans.
• Guide companion diagnostic programs. Serve as the regulatory lead for biopharma collaborations, aligning diagnostic and therapeutic development plans, clinical trial assay readiness, evidence generation, filing strategy, and labeling considerations.
• Shape development plans. Partner with assay development, computational biology, laboratory operations, quality, and program teams to define analytical and clinical performance studies that support the intended use and proposed claims.
• Ensure submission-ready evidence. Critically review protocols, reports, and technical documentation, including pre-analytical variables, specimen stability, analytical validation, software V&V, clinical performance, and bridging studies, to ensure conclusions are accurate and well supported.
• Set expectations and regulatory requirements for IVD s , including software and bioinformatics. Define regulatory requirements for IVD product(s), including s oftware, algorithms, and bioinformatics pipelines used in regulated products or in data supporting diagnostic and therapeutic submissions .
• Embed regulatory requirements in the quality system. Contribute to design and development controls, risk management, document control, and audit and inspection readiness in alignment with FDA's Quality Management System Regulation, ISO 13485, ISO 14971, and CLIA and CAP requirements as applicable.
• Assess changes and communications. Evaluate product, design, software, manufacturing, and labeling changes for regulatory impact, and review product communications and Research Use Only claims for compliance.
• Manage regulatory risk. Interpret evolving requirements, identify risks early, and recommend practical, science-based paths that protect patients, program objectives , and business priorities

What You Bring

• Bachelor's degree in life sciences, engineering, or a related field .
• At 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.
• Excellent technical writing and communication skills, including the ability to explain complex issues clearly to regulators, partners, scientists, and senior leaders.
• Sound judgment and comfort operating in a growth-stage environment, balancing strategic direction with hands‑on execution and managing multiple priorities with limited oversight.

Preferred Experience

• Companion diagnostic development, particularly oncology programs and coordination of diagnostic and therapeutic regulatory strategies from clinical development through approval.
• Liquid biopsy, epigenomics, oncology diagnostics, or biomarker-driven drug development.
• Global IVD registrations, including familiarity with the European Union In Vitro Diagnostic Medical Devices Regulation and technical documentation expectations.
• Regulatory oversight of software and bioinformatics lifecycle documentation for complex diagnostic products.
• An advanced scientific degree or Regulatory Affairs Certification.

The expected salary range for this role is $175,000 to $220,000 per year. Final compensation will reflect the candidate's qualifications, experience, and geographic location. Employees are also eligible for a performance bonus, equity participation, and comprehensive health benefits.

We believe in building an inclusive and balanced team, and we know that strong candidates may not meet every qualification listed.

Precede Biosciences is an equal opportunity employer. We do not discriminate based on race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other status protected by applicable law.

Precede Biosciences does not accept unsolicited resumes from recruitment agencies or external recruiters. No fees will be paid for unsolicited submissions.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.