6325 Topanga Cyn Blvd #433
Woodland Hills, CA 91367
Senior Quality System Specialist
General Job Description:
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.
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.
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 firstname.lastname@example.org
Learn more about Regenimmune here