Overview
QA/RA Associate Jobs in San Francisco Bay Area at LifeScience PLUS, Inc
Title: QA/RA Associate
Company: LifeScience PLUS, Inc
Location: San Francisco Bay Area
Job Type: Part to full-time, hybrid on-site and remote
Note: This position is a job share with current QA/QMS Director
Description: The position is responsible for maintenance of the quality system; product technical files and submissions, certification renewals, periodic updates and registrations to regulatory agencies; review of product and regulatory changes for impact on regulatory filings; research of regulatory issues to provide guidance and advice to senior management.
Specific Duties and Responsibilities :
Medical device product line responsibilities:
o   Maintenance of product technical files
o   Maintenance of current product approvals and registrations, including initiation of product testing as necessary to maintain approvals: sterilization, biocompatibility, shelf life stability, etc
o   New product submissions
o   Support of international distribution partners with required reports and documentation for product approvals and registrations in their markets
o   Post-market surveillance activities, including regulatory reviews of customer complaints and determination of regulatory reportability, advisory notice or recall as applicable
o   Advice to executive management on impact of regulation changes, strategies for compliance
o   Regulatory guidance to development project teams regarding design, development, evaluation, and marketing of products
o   Maintenance of company and product information in GUDID, and EUDAMED databases
o   Risk Management, incorporating new inputs into risk analysis and risk assessment
o   Review of labeling, advertising, and marketing materials for compliance to regulatory requirements
·        Quality management system responsibilities:
o   Establishment and maintenance of the quality system in compliance with the requirements of FDA QSR, ISO 13485, EU MDR.
o   Internal Audits
o   Preparation of Management Reviews, including compiling, analyzing, trending and presenting data and QMS metrics
o   Participation in vendor evaluation, selection, and performance evaluation.
Other duties as assigned
Requirements:
BA degree in a science or related field
Minimum 5 years’ experience in medical device regulatory affairs
Strong working knowledge of US and EU medical device regulations
Strong working knowledge and experience with quality systems regulations (FDA QSR, ISO 13485, EU MDR)
Self-Management: possesses integrity, flexibility, good use of time.
Good communication skills, both verbal and written
Effective project management and problem-solving skills
Good organizational ability and strong attention to detail
