Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the formulation and implementation of regulatory strategies for NGS-based IVD products outside the United States.

• Focus on regulatory activities related to EU IVDR and Health Canada, which include technical documentation, engagement with Notified Bodies, PRRC responsibilities, EU Declaration of Conformity, and Medical Device License applications.

• Develop regulatory roadmaps for global expansion, addressing market-entry sequencing, gap analyses, and localization needs.

• Act as the primary liaison and chief negotiator with international regulatory bodies and Notified Bodies.

• Keep abreast of global regulatory developments and translate these changes into actionable strategies and process modifications.

• Manage international technical files, design dossiers, and obligations related to post-market surveillance and vigilance reporting.

• Direct regulatory efforts for biopharmaceutical co-development and companion diagnostic collaborations.

• Ensure the alignment of CDx regulatory strategies with partner drug development timelines, assisting with labeling, indications for use, and co-development agreements.

• Maintain an updated understanding of US FDA pathways and ensure global submission content, labeling, and change control assessments are aligned.

• Assist in the regulatory planning for international clinical trials and clinical programs.

• Mentor junior members of the Regulatory team, providing both technical and strategic guidance.

• Collaborate with R&D, Quality, and cross-functional product development teams.

• Present risk assessments and mitigation plans to leadership.

• Contribute to budgeting, resource allocation, and SOP development for international regulatory operations.

• Domestic and international travel is required, estimated at 10%.

⛳️ Requirements

• A Bachelor's degree in a life sciences, engineering, or a related scientific field; an advanced degree (MS, PhD, or equivalent) is preferred.

• Over 12 years of progressive experience in regulatory affairs within the IVD, molecular diagnostics, medical device, or biopharmaceutical industries.

• Hands-on experience with EU IVDR technical documentation and submissions to Notified Bodies.

• Familiarity with Health Canada Medical Device License applications.

• At least 2 years of supervisory experience.

• Proven experience in developing and executing global/international regulatory strategies across various product lines or markets.

• Knowledge of US FDA regulatory pathways for IVDs (510(k), De Novo, PMA) and considerations for CLIA/laboratory-developed tests.

• Experience interacting directly with regulatory authorities and/or Notified Bodies, including leading agency meetings and negotiations for submissions.

• Strong understanding of quality system frameworks pertinent to IVDs (ISO 13485, ISO 14971, IEC 62304 for software as a medical device).

• Exceptional written and verbal communication abilities, with experience presenting to senior leadership and external stakeholders.

• Demonstrated leadership skills, with the capacity to mentor and develop regulatory personnel.

• Adaptive is not currently sponsoring candidates who require work authorization support for this position.

🏝️ Benefits

• Equity grant

• Bonus eligible

• Comprehensive Adaptive benefits package (benefits at-a-glance provided)

• Affirmative Action and Equal Opportunity Employer

• Reasonable accommodation support for disabled job seekers