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Senior Quality System Specialist

March 8, 2019

  

 

 

 

 

 

 

Company Name:

Regenimmune Inc

 

Job Location:

6325 Topanga Cyn Blvd #433

Woodland Hills, CA 91367

 

Position Title: 

Senior Quality System Specialist

 

Position Type:

Full Time

 

General Job Description:

 

Responsibilities

  • Develop, implement, and maintain compliance to FDA QSR, ISO 13485, and other related Federal, State and Local regulations or standards, as it applies to the business.

  • Manage document control, complaint, supplier control, NCR, and CAPA processes.

  • Identify Quality System deficiencies through internal audits and assist individual departments in their correction.

  • Make recommendations to the President and Management Representative for correction of deficiencies.

  • Ensure training of REGENimmune personnel is in compliance with the Quality Manual.

  • Maintain training records.

  • In cooperation with the President and CSO, develop training programs for company personnel.

  • Review all V&V protocols to ensure they meet FDA regulations and guidance and are in compliance with ISO 13485 and ISO 14155, as applicable.

  • Assist in domestic and global submissions related to pre- and post-market needs.

  • Maintain Establishment Registrations, Device Listings, and Import/Export filings, as needed.

  • Vigilance and MDR reporting, as needed.

  • Assist in the development of regulatory strategies and plans for new or modified products.

  • Review labeling and marketing materials for compliance with US and other country regulations as required; recommends appropriate changes.

  • Monitor activities/publications of FDA and international regulatory bodies to identify and respond to new or revised regulatory requirements.

  • Lead design control and risk management activities, as required.

  • Communicate with regulatory authorities, as needed.

  • Develop regulatory documents, as directed by the Management Representative and President. 

  • Develop budgets, plans, and priorities for QA activities.

  • Act as a Quality System leader within the organization.

  • Other activities as assigned by the Management Representative and/or President.

  • Authorities and Reporting.  The Senior Quality System Specialist reports to the Management Representative.

 

Liaison

  • Chief Scientific Officer

  • Other REGENimmune employees

  • Regulatory Affairs Consultant

  • Quality Systems Consultant

  • Domestic and Global Regulatory Authorities

  • Supervises.  Supervises, up to three part-time Quality Assurance employees.

  • Travel:  10-20%

 

Qualifications:

 

The Senior Quality System Specialist shall possess at least 2 years experience working with a medical device quality system, 5 years experience in the medical device industry and, ideally, some pre-market regulatory affairs experience. Good verbal, written and organizational skills; strong leadership, interpersonal and communication skills; and the ability to work effectively in a fast-paced, start-up environment. The Senior Quality System Specialist shall demonstrate familiarity with HIPAA, IRB, IDE, CE Mark, and 510(k) submission requirements.

 

 

Application Information & Contact (How to Apply)

 

Please apply by emailing periodaisy@yahoo.com

Learn more about Regenimmune here

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