Post Market Complaint Analyst - IVDR

Sunnyvale, CA

Posted: 04/14/2020 Position Categories: Administrative: Technical Writing/Publishing

Job Description

Executes Quality Systems and Regulatory Compliance requirements in conjunction with Company, Business and Regulatory requirements. Coordinates Quality System / Regulatory Compliance (QS/RC) interactions, requirements and compliance activities interfacing with Technical Service, Technical Support and other customer support teams.  Responsible for assisting with IVDR activities including complaint handling, developing post market surveillance plans and reports

 

ESSENTIAL JOB RESPONSIBILITIES:

  • Help develop Product PMS plans and reports related to IVDR requirements
  • Work with cross functional IVDR teams to complete deliverables
  • Support integration of the Post Market Process into all facets of the new IVDR regulations to include management controls, Complaint Handling, Corrective and Preventive Actions, and Risk Management.
  • Work with global post market functions (Risk, CAPA) to ensure IVDR compliance
  • Ensure documents updated, formatted, develop document control system
  • Support changes to QS/RC processes through timely analysis and completion of field reports, service requests and customer complaints
  • Ensure documents updated, formatted, develop document control system
  • Ensure all actions required by Core Team/Project Manager delivered in timely manner with clear reporting upwards
  • Develop SOPs /WIs in agile doc control system
  • Partner with Quality Systems to continuously evaluate and improve internal compliance systems
  • Continuously review requirements and practices in customer-facing responsibilities to ensure compliance to business, customer and regulatory needs
  • Support continuous improvement of the Cepheid quality system meeting both operational quality and regulatory requirements.
  • Ensure compliance to regulatory standards, as applicable.
  • Prepare formal written reports/documents for distribution within work unit and regions.

Job Requirements

Education or Experience (in years): 

  • Bachelor’s degree or equivalent in Molecular Biology, Biology, Chemistry or related scientific discipline with at least 2 years of experience in a fast paced regulatory/compliance/quality team ideally in a medical environment
  • Understanding of quality and QS/RC compliance requirements in relationship to product performance and customer expectation.

 

 

Knowledge and skills: 

  • Strong knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA’s QSRs, EU’s MDD, Canadian Regulations) is required.
  • Strong technical and written communication skills
  • Possess essential skills for prioritizing workload and responsibilities
  • Interprets subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.
  • Able to confidently deal with ambiguous issues and provide input towards suitable actions.
  • Strong written communication, interpersonal, negotiations and problem solving skills
  • Effective communicator of technical & non-technical information
  • Ability to work in a self-directed manner to see issues through to completion.
  • Exceptionally strong team player with excellent interpersonal, and experience working with end-users in a mentoring capacity
  • Proficient with the Microsoft Office suite.

Additional Information

For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.

Richmar is an Equal Opportunity Employer.

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