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Quality Assurance and Regulatory Affairs Specialist

Company: Medical Instrument Development Laboratories, Inc.
Location: San Leandro
Posted on: July 28, 2022

Job Description:

Mid Labs is a California-based medical device company currently focused on developing novel products for vitreoretinal surgery. Mid Labs was acquired by HOYA Surgical Optics, the intraocular lens division of HOYA Group, in 2019.Main Purpose of Job:We are seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy. This position supports the RA function by assisting with the coordination and preparation of global regulatory premarket submissions and provide all around Quality Engineering support to Project Team/Manufacturing.Key Duties & Responsibilities:

  • Author or revise Standard Operating Procedure (SOPs) to improve regulatory compliance of the quality management system
  • Work closely with R&D through product development process and design activities including sterilization, packaging, shelf life, and biocompatibility
  • Author/participate in design validation and process validations, IQ, OQ, PQ
  • Prepare, review, and approve risk management files and support risk management activities including hazard analysis and FMEA
  • Assist with environmental regulations and standards (i.e. RoHS, WEEE Directive, REACH, etc.)
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
  • Assist the organization and preparation of regulatory submissions and all applicable documentation
  • Coordinate, investigate, analyze product complaints and/or safety issues and make recommendations regarding their reportability and resolution
  • Monitor post-production events and reporting of adverse events
  • Participate in internal or external audits
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
  • Interpret domestic or international laws, guidelines, standards, regulatory rules, or rule changes and ensure that they are communicated through corporate policies and procedures
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Directive (MDD), Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope
  • Review and/or approve product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
  • Lead effort in resolution on non-conforming materials in MRB. Interface with supplier base to resolve quality and compliance issues
  • Administer CAPA Program. Perform CAPA investigations, implement corrective actions and perform effectiveness checks
  • Coordinate and develop effective receiving inspection, in-process and end-of-line testing activities. Facilitate lot release testing and sterilization review activities
  • Establish and maintain statistical sampling methods for inspection activities
  • Fluent in the proper selection and use of coordinate-measuring machine, optical measurement system, optical comparator, calipers, drop indicator, micrometers, gage pin, etc
  • Ability to write routine reports and clearly communicate effectively in a team setting
  • Ability to read and interpret documents including drawings (including geometric dimensioning and tolerancing), standards, production documents, test documents, maintenance instructions etc.
  • Support and improve company Quality Systems by creating a quality culture and provide on-going education on compliance activities
  • Contribute towards accomplishment of departmental and corporate goals and objectives
  • All other duties as requested by his/her managerEducation
    • Bachelor's degree preferably in a scientific discipline such as Science or Engineering or equivalent experienceExperience
      • At least 3 years of Class II medical device quality and/or regulatory experience is required
      • Regulatory Affairs Certification (RAC) is a plusSkills
        • Strong regulatory/quality writing skills
        • Ability to apply business and Regulatory Affairs ethical standards
        • Excellent analytical and critical thinking skills
        • Able to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilization
        • Strong verbal and written communication skills, including a proven ability to translate technical documentation into effective quality documentation and regulatory submissions
        • Strong understanding of FDA and EU regulatory process
        • Experience in Risk Management per ISO 14971 and QMS per ISO 13485
        • Good interpersonal skills and able to work well with cross-functional teams
        • Able to work independently with minimal instructions/supervision
        • Capable of multi-tasking and rapidly adapting to changing prioritiesOther Requirements
          • Candidate must be authorized to work in the USABy submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes.We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.

Keywords: Medical Instrument Development Laboratories, Inc., San Leandro , Quality Assurance and Regulatory Affairs Specialist, Other , San Leandro, California

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