35 applicants

Company

GeneDx · 1 day ago

Regulatory & Quality Manager

Gaithersburg, MD

Full-time

Remote

Mid Level

$130K/yr - $145K/yr

4+ years exp

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Responsibilities

Manage the development and implementation of quality assurance and regulatory policies to FDA, and ISO 13485 requirements while maintaining compliance to other applicable regulations (e.g. CLIA, CAP, New York State CLEP).

Lead the monitoring and interpretation of changes to FDA and ISO 13485 quality and regulatory requirements and provide guidance to GeneDx cross-functional teams.

Work closely with Operations, Product & Technology, Commercial, Medical Affairs and other teams to ensure applicable quality assurance & regulatory requirements are defined, documented, and implemented via Policies and SOPs.

Provide quality assurance guidance during design and development processes, risk management, change management, process validation/controls, and equipment qualification including for software integral to the IVD product.

Support development and implementation of QMS Management Review and Post Market Surveillance that align to FDA and ISO 13485 requirements.

Support the preparation of regulatory submissions including to relevant authorities.

Support regulatory inspections and audits, ensuring successful outcomes.

Provide mentorship, regulatory and quality training to internal teams or cross-functional peers and on maintaining compliance with the applicable QMS requirements and regulations.

Identify and drive continuous improvements initiatives that enhance quality culture within the organization.

Qualification

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FDA IVD requirementsISO 13485ISO 14971IEC 62304CLIAState CLEPQuality Management System (QMS)Software as a Medical Device (SaMD)Regulatory Affairs Certification (RAC)Technical writingProject managementProblem-solving abilities

Required

A bachelor's or advanced degree in a relevant field scientific or technical field (e.g., Biology, Chemistry, Biotechnology, Engineering).

Minimum of 4 years of experience in quality and regulatory affairs within the medical device or IVD industry.

Practical experience with FDA, ISO 13485, ISO 14971, IEC 62304 and ISO 15189 regulations.

Working expertise in FDA IVD requirements, ISO (13485, 14971, 15189, etc.), IEC 62304 and knowledge of CLIA and New York State CLEP requirements.

Ability to work independently and as part of a cross-functional team.

Ability to lead projects involving cross-functional teams.

Strong project management and organizational skills.

Excellent communication and interpersonal skills.

Detail-oriented with strong analytical and problem-solving abilities.

Preferred

Certifications in Regulatory Affairs or Quality Assurance preferred.

Experience working with software as a medical device (SaMD) regulation is preferred.

Knowledge of design and development with software used as a medical device (SaMD) or software used as component in a medical devices / IVDs and applicable regulations.

Excellent technical writing skills.

Regulatory Affairs Professional Certification (RAC) preferred.

Working experience in a clinical genetics laboratory is desired.