Sr. RA Manager
QualStaff Resources San Diego, CA
- Expired: over a month ago. Applications are no longer accepted.
- Supports the company Quality System to comply with the FDA’s QSR, and ISO 13485 Standards
- Serve as Regulatory lead for Change Control, Material Review Board, Validations, Corrective/Preventative Actions, Continuous Improvement, Complaint Handling, and Post Market monitoring activities
- Works with Quality and Clinical to support areas such as Submissions, Technical Files, CE Mark, etc., and other countries as business dictates.
- Implements and oversees the processes per the IVDR EU Regulations
- Provide training, guidance and coaching for GMP/GDP/Quality Systems, and Regulatory actions.
- Perform regulatory activities such as, but not limited to: submissions, clinical trials, document reviews, agency reporting, MDR reviews and reports, registration renewals and maintenance, recalls and/or field actions, etc.
- Establish, build and maintain professional working relationships with all levels of staff, distributors, customers, suppliers, and government agencies
- Support Product and Process Development process for new products, product changes and enhancements
- Other duties as assigned; as emerging growth company it may be required from time to time to assist in other areas other than the area of specialty
- Commercialization of in-vitro diagnostic platforms
- Experience with the development of point-of-care, in-vitro diagnostic platforms that address FDA’s Quality System Regulation and ISO 13485 design control requirements
- Experience driving company goals and objectives, policies and procedures, compliance to FDA regulations and ISO standards throughout an organization
- Experience making sound decisions in a timely manner, based upon a mixture of analysis, wisdom, experience and judgment
- Experience resolving issues and overcoming obstacles to assure successful outcomes; uses independent judgment to resolve unique challenges that arise periodically
- Experience managing multiple activities and priorities concurrently to accomplish a goal; uses resources effectively and efficiently
- Excellent interpersonal, verbal and written communication skills, meticulous attention to detail and meeting deadlines
- Self-starter with a can-do attitude to drive quality and regulatory excellence in a fast-paced regulated start up environment
- Strong knowledge of the FDA QSR and ISO 13485 as well as the point-of-care, in-vitro diagnostic. Knowledge of other country directives and regulations is highly preferred
- Prior experience in the Medical Device and/or IVD industry with early stage (Start–up) company experience highly preferred
- Experience leading or assisting with 510(k) or PMA submissions
- Experience with complaint handling, review for reportability, and submitting MDR/Vigilance reports
- Design control experience with 510k and/or PMA IVD/POC products
- Must possess excellent written and verbal communication skills
- Experience with medical device and/or IVD manufacturing process validations using the IQ/OQ/PQ format
- Intermediate level skill in Microsoft Word, Excel, Outlook and other office software programs.
- A minimum of a BS or BA in Engineering, Biology, Chemistry or equivalent and relevant industry experience
- Minimum 7 years’ experience in Regulatory Affairs with responsibility for FDA submissions, registrations, complaint review for reportability, and generating/submitting agency reports (i.e., MDRs, Vigilance, etc.)
AddressSan Diego, CA
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