106 applicants

Company

Ambry Genetics · 2 days ago

Regulatory Specialist II (REMOTE, USA)

Aliso Viejo, CA

Full-time

Remote

Mid Level

$90K/yr - $100K/yr

3+ years exp

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Responsibilities

Coordinate and support preparation of submission regulatory documentation, including pre-market submissions, product registrations, and amendments.

Maintain accurate and up-to-date regulatory records and files.

Monitor and interpret regulations related to genetic testing, including FDA, CLIA, NYS , international regulations, IVDR, UK MDR2002 and other relevant standards.

Ensure compliance with regulatory requirements throughout the product lifecycle and post market monitoring.

Maintain, review and/or update regulatory documentation.

Review labeling, packaging and package inserts, marketing materials.

Write and review SOPs, write and support multiple regulatory writing activities.

Identify potential regulatory risks and develop strategies to mitigate them.

Conduct regulatory audits and assessments to ensure compliance and readiness for inspections.

Work closely with R&D, clinical operations, quality assurance, IT, and marketing teams to provide regulatory guidance and support.

Stay informed on industry trends, regulatory changes, and emerging technologies in genetic testing and IVDs.

Other duties as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory complianceRegulatory documentationRisk managementMedical device experienceClinical diagnostics experienceFDA regulationsInternational regulationsTechnical writingDegree in life scienceRegulatory Affairs Certification (RAC)Software validationCybersecurity in medical devicesLifecycle managementProgram management skills

Required

Bachelor’s degree in life science field (i.e., molecular genetics, biology, microbiology, chemistry, engineering, medical technology, regulatory science), or equivalent experience

Min 3yrs of medical device and/or clinical diagnostics regulatory experience required

Knowledge of international and federal, state, and accreditation body requirements (CAP, CLIA, NY, FDA, PMDA, EU)

Strong analytical, written/verbal communication, interpersonal, and relationship building skills

Ability to work well with quality, clinical, medical, bioinformatics, and laboratory teams

Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs

Exercise independent judgment and discretion within a broadly defined range of policies and practices, which includes analytical problem-solving and decision-making

Demonstrate organizational, planning, and program management skills, including action oriented, focused urgency and driving results.

Experience in writing technical and regulatory documentation.

Preferred

Master’s degree preferred

Regulatory Affairs related Training/Certification desirable (RAC)

Experience with: Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, CTA’s applications, Investigational Device Exemption (IDE) requirements

Ex-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDR

Software validation and risk management

Cybersecurity in medical devices

Lifecycle management of medical devices/IVDs