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
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