Regulatory Affairs Director

Company: MAU Workforce Solutions
Location: Ogden
Posted on: June 25, 2022

Job Description:

Regulatory Affairs DirectorSUMMARY:Expand your professional portfolio as a REMOTE Regulatory Affairs Director. As the Regulatory Affairs Director, you will oversee and complete strategies associated with regulatory approval of In Vitro Diagnostic (IVD) medical devices. They are responsible for the activities that lead to and maintain domestic and international regulatory approval for marketed devices. This is a direct-hire opportunity.REWARDS:

• Competitive pay
• Great hours
• Direct-hire opportunity
• Remote position
• Preferably based in Ogden, UT or Charlottesville, VAREQUIREMENTS:
  • B.Sc. degree in Biology, Chemistry, bio-engineering or related science
  • 5 years of IVD Regulatory Affairs experience (preferred)
  • Regulatory Affairs Certification (preferred)
  • Previous experience with 510 (k), PMA, PMA supplement submissions and/or EU MDR / IVDR Technical File creation and maintenance
  • Well versed in the aspects of regulatory strategy creation, design control, cGMP / Quality Systems, and import / export requirements
  • Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies
  • Experience in the balance and application of regulatory requirements
  • Direct and positive experience in communicating with Regulatory Authorities and co-development partners
  • Ability to regulatory review promotional marketing materials, press releases, labeling, etc.
  • Demonstrate in-depth understanding of advanced technical / scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices
  • Capacity to communicate regulations to technical functions within the Company's knowledge, skills, abilities
  • Able to work autonomously in a matrix-managed organizationRESPONSIBILITIES:
    • Responsible for providing guidance to assure that all regulatory submissions are planned, communicated, and executed per regulatory and business requirements
    • Be the subject matter expert on various regulations and coordinates regulatory issue resolution using internal resources, regulatory agencies, and outside consultants as needed
    • Deliver regulatory guidance to project teams and external partners key activities toward assisting the company in achieving its business goals
    • Serve as a member of the company's Global Regulatory department
    • Be the Regulatory Core Team Lead assisting Regulatory department in the update, enhancement, and creation of internal policies and procedures
    • Document regulatory strategies for product submissions
    • Facilitate and prepare US regulatory pre-submission documents for PCR assays/instrumentation
    • Facilitate FDA pre-submission meetings
    • Prepare US regulatory submissions (510 (k)) for PCR assays
    • Support EU representatives in their creation of CE / IVD Technical Files
    • Support global regulatory registration representatives for product global registration activities
    • Perform regulatory assessment of new and changed products
    • Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
    • Conduct trainings and/or communicate appropriate materials, as needed MAUMAU Workforce Solutions is an innovative global company with extensive experience providing solutions for success in staffing, recruiting, technology and outsourcing to our clients, employees and applicants. Headquartered in Augusta, GA since 1973, MAU is a family and minority-owned company offering better processes and better people to create efficiencies and greater profits for our clients. Our relationships with world-class companies, our training programs and our culture of family allow MAU to offer better results, better jobs and better lives to those who work with us.Disclaimer: All applicants must submit to background check and drug screening.This position does not offer sponsorshipEqual Opportunity EmployerMinorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply

Keywords: MAU Workforce Solutions, Ogden , Regulatory Affairs Director, Executive , Ogden, Utah