Title: Senior Regulatory Compliance Specialist
Reports to: Sr. Director RA/QA
Department: Regulatory Compliance
Invuity, Inc. is committed to leveraging advanced photonics technology to transform and create a new standard of care for minimal access surgery. The Company’s patented Intelligent Photonics™ devices provide superior visualization of the surgical cavity enabling precision, efficiency, and safety. Clinical applications include breast and thyroid oncology, plastics, spine, orthopedic, cardiothoracic and general surgery among others.
Position Description :
Responsible for data-to-day support of processes used to demonstrate compliance with state (California Food and Drug Branch), federal (US Food and Drug Administration) and international regulations and standards for medical devices, including but not limited to: Day-to-day management of Internal Audits and the Corrective Action / Preventive Action program activities; GUDID data management and UDI implementation. Revise / develop quality systems procedures as required.
Essential Duties and Responsibilities:
Project Management / Support CE Mark, ISO 13485:2016 transition; EU MDR transition; and OUS Registration (EU and Japan).
Support ISO certification audits and FDA, FDB, EU and MDSAP regulatory inspections.
Preparation and maintenance of Technical Files.
Day-to-day management and primary oversight of Invuity’s CAPA program including:
Coordination of CAPA Board Meetings developing agendas, preparing meeting minutes, and providing CAPA status.
Ensuring all CAPA records are established, maintained, well documented, and compliant to CAPA program requirements.
Performance and/or review of CAPA of investigations, root cause analysis and action plan development.
Performance / coordination of CAPA verification of effectiveness reviews.
Generates monthly ANR / CAPA metrics for distribution to executive management.
Day-to-day management and primary oversight of Invuity’s Internal Audit program including:
Coordination and performance of Internal Audit activities in accordance with the Internal Audit schedule.
Ensuring all Audit records are established, maintained, well documented, and compliant to audit program requirements.
Performs Audit Nonconformance Report (ANR) follow-up reviews and file closure
Provide guidance to ANR / CAPA Owners on investigations, root cause analysis and action plan development.
Primary contact and oversight for Invuity’s UDI / GUDID programs including:
Issuing GTIN number from GS1 database.
Generation and maintenance of GUDID records both internally and in the FDA GUDID system.
Supports Quality Assurance and Regulatory as required.
Knowledgeable in applicable international regulations and standards (QSR, MDD / EU MDR, ISO 13485, CMDCAS, etc.). Excel, word, power point. Project Management skills. Strong communication skills including English writing and grammar.
Works from verbal and/or written instructions. Must demonstrate a high level of attention to detail. Requires minimal direct supervision.
Minimum 8-10 years’ experience in the medical devices field or similar regulated field such as biologics or pharmaceuticals.
Strong ISO 13485, Quality System Regulation (21 CFR part 820) and MDD (92/42/EEC).
Working knowledge of 21 CFR part 801 Subpart B (Labeling Requirements for Unique Device Identification) and 21 CFR part 830 (Unique Device Identification, including GUDID).
Strong CAPA and Internal Audit program experience
Formal internal audit training / certification
Additional Experience that would be a plus:
Familiarity with 21 CFR part 11, ISO 13485:2016, MDSAP and new EU MDR
510(k) and/or international product registrations.
Familiarity GUDID data entry on FDA site, GS1 and GMDN site interfaces.
Familiar with a variety of the field’s concepts, practices, procedures and regulations.