Open Position: Manager, RA/QA
Function: Regulatory Affairs/Quality Assurance (RA/QA)
Contributes their analytical and compliance (quality and regulatory) skills to the successful development of medical devices and combination products as well as to the Quality System elements required to support the development and maintenance of such products. An integral member of the QA/RA team—will be interacting with teams involved with FDA, CE Mark, and CLIA compliance issues involved with product development cycle and its impact on the post market requirements.
Please send your resume and a cover letter to [email protected] and include Manager, RA/QA in the Title.
Essential Duties and Responsibilities
- Support the Quality (Management) Representative of the EdgeOne Quality System with maintenance and continuous improvement of the EdgeOne’s ISO 13485 compliant QMS
- Support the development and remediation of client Quality Systems
- Participate in internal and external audits, observations, responses and applicable certifications. Incumbent may be responsible for leading audits if appropriate background / certification is present.
- Contribute to quality system and product development deliverables (i.e., Procedures, Risk Assessments, CAPAs, Complaints, protocols/reports, etc.) for client specific projects
- Support and contribute to development of regulatory strategies, submissions and pre-submission meeting requests with agency
- Participate in the coaching, training and mentoring of both EdgeOne employees and Clients on all facets of quality and regulatory requirements and processes that impact regulatory filings, the quality system or client product
- Support Quality review of laboratory documentation, including testing protocols and reports
- Monitor the implementation and effectiveness of the EdgeOne Quality system
- Assist in the review of data feeders including but not limited to internal and external audit observations, CAPA’s, process behavior trends, customer feedback, and management review to determine effectiveness of the quality system
- Partner with suppliers in providing necessary services to the client
- Develop client relationships and personnel commensurate with their job responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Equal Employment Opportunity
- Bachelor’s degree in Engineering, Life Science, or Equivalent
- 5-8 years experience in quality systems and regulatory related to medical devices
- Thorough understanding and experience with ISO 14971:2007, 13485:2016, and 21CFR820
- Experience and familiarity with US and European regulatory filings. Other country or regional regulatory experience and familiarity is beneficial (i.e. Japan, Australia and Canada)
- Broad knowledge of the Product Development Processes and its supporting quality systems.
- Strong leadership, facilitation, mentoring, and communication skills
- Strong multi-tasking and project management skills
- Must be able to interact and communicate with all levels of an organization
- Must be able to interface with clients on a personal level
- Motivation and desire to share your knowledge with the broader industry community
Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.