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Sr. RA Manager

QualStaff Resources San Diego, CA

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Overview:
Provide Regulatory Affairs direction and hands-on support to all departments in activities such as but not limited to: design control process, process development, process validation, manufacturing, complaint handling, and regulatory submissions/compliance.

Duties:
  • 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

Skills:
  • 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

Requirements:
  • 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.
Education:
  • 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.)
 

QualStaff Resources

Address

San Diego, CA
USA

Industry

Government

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