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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. , Peabody , Senior QRA Specialist , Operations, Logistics & Warehousing , Danvers, Massachusetts , Massachusetts

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Senior QRA Specialist
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 (more...)
Company: Leica Biosystems Richmond, Inc.
Location: Danvers, Massachusetts
Posted on: 02/6/2020

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