Manager of RA/QA
Company: Aurora Spine
Position: Manager of RA/QA
Location: Carlsdbad, CA
Posted: September 20, 2020
Please Contact Director of Engineering Jeremi Leasure firstname.lastname@example.org with Cover Letter and Resume
3.0 Education requirements
3.1 Bachelor Science (or equivalent) required
3.2 Masters (or equivalent) or advance studies desired.
4.0 Experience requirements
4.1 Minimum of 10 years experience in regulatory affairs and/or quality assurance required.
4.2 Senior management experience required.
4.3 Moderate clinical background (e.g., familiarity with animal studies, operating room environment, working with physicians) required.
4.4 Experience in working with regulatory agencies (e.g., FDA, competent authorities) and registrars / notified bodies highly desired.
4.5 Experience in orthopedic industry desired.
5.0 Job requirements
5.1 Function as the Company’s Management Representative. Fully implement the quality management system and ensure that the Company is in compliance with ‘Regulations’ (I.e., QSR, CMDR and MDSAP), ‘Standards’ (I.e., ISO 13485) and the Quality Manual.
5.2 Responsibilities as Management Representative include:
5.2.1 Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and
5.2.2 Reporting on the performance of the quality system to management with executive responsibility for review.
5.2.3 Responsible for promoting awareness of regulatory and customer requirements throughout the organization. This includes creating, presenting and ensuring completion of the QSR / ISO / MDSAP / CMDR training for applicable employees.
5.2.4 Direct, implement and monitor regulatory and corporate compliance.
5.2.5 Official correspondent to the U.S. FDA and other regulatory agencies. This includes keeping the notified body / registrar informed of any significant changes as defined by the MDSAP / CMDR.
5.2.6 Evaluate regulatory requirements and institute quality policies to meet current industry standards.
5.2.7 Review and approve all documentation associated with manufacturing, validations, change control, deviations and operating procedures.
5.2.8 Manage regulatory and compliance information, filings for new product approvals, schedules and requirements.
5.2.9 Coordinate recalls, notifications, adverse events and other safety reports to FDA.
5.2.10 Responsible for internal and external audits.
5.2.11 Responsible for creating, approving and maintaining the technical file, and responsible for ensuring that all necessary certifications (I.e., ISO 13485 and MDSAP) are in place and applicable prior to approving any technical file.
5.2.12 Responsible for creating and maintaining the clinical data, and responsible for obtaining and approval of, the clinical data report from a person suitably qualified in the relevant field and knowledgeable in the current state-of-the-art (I.e., a spine surgeon).
5.2.13 Other duties as assigned