Senior QRA Specialist
Company: Leica Biosystems Richmond, Inc.
Location: Danvers, Massachusetts
Posted on: February 6, 2020
Job Description:
Duties: Manage the quality system and regulatory activities
within the LBS Companion Diagnostics (CDx) development team within the Advance Staining business unit. Work closely
with QRA management in collecting and reporting metrics for RA/QA KPIs to Senior Management. Establish and
maintain compliance to all applicable quality system requirements supporting the development of in vitro diagnostic
devices intended for CDx use. Provide management of key Quality System processes including document and training
management, CAPA program management, supplier qualification process management, nonconformance and deviation
process management. Responsible for planning, organizing and conducting activities related to assigned areas
of the sites regulatory obligations. Work with global colleagues in support of product registrations and submissions,
device listings and licenses according to government requirements. Serve as site RA representative on new product
development teams and change management initiative. Review and approve labeling and advertising and promotion
materials for compliance to applicable regulations. In conjunction with management, develop plans to implement any
regulations that have a significant impact on the business (e.g. IVDR, MDR etc.) Supporting Adverse events and
patient safety Recalls activities (MDR, Vigilance, clinical trials). Use Danaher Business System (DBS) tools on a regular
basis to continually improve the RA and Quality systems. Establish and maintain strong relationships with
internal and external stakeholders. Requirements: Master's degree in pharmacology, pharmacy or
related field (willing to accept foreign education equivalent) plus three years of experience in industry related
quality assurance experience in regulatory affairs., including Preparing, reviewing, and submitting materials for CDx
Assay PMAs, 510(k), MDEL and/or CE marking and integrating drug development partner requirements into local
quality and design control systems in compliance with 21 CFR part 820, ISO 13485 and EU IVDD regulations; Managing
medical device quality systems, integrating drug development partner requirements into local quality and design
control systems in compliance with 21 CFR part 820, ISO 13485 and EU IVDD/IVDR regulations; ISO Quality System
Auditor Training Certification (i.e. 13485:2016 or equivalent) and experience in leading, conducting, hosting and
managing quality system, internal, external and customer audits; Proficient in the review and approval of
marketing, advertising, promotional, scientific, and sales (MAPSS) materials, and compliance with applicable labeling
requirements and regulations. Position requires 10% travel. Qualified candidates please e-mail resume to
MaryAnn.Marcuzzi@LeicaBiosystems.com and reference job title.
Keywords: Leica Biosystems Richmond, Inc. , Marthas Vineyard , Senior QRA Specialist , Operations, Logistics & Warehousing , Danvers, Massachusetts , Massachusetts
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