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Regulatory Affairs Ops Technical Writer Specialist - 19489

iMPact Business Group Fremont, CA

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

Job Description

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Regulatory Affairs Ops Technical Writer Specialist for a 12 Month + Contract Opportunity.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail-oriented Top Talents in an extremely collaborative and professional environment. 

 

Responsibilities

 

As the Regulatory Affairs Ops Specialist you will perform the following tasks:

 

  • Manage and transact data between several company systems keeping the database as source of truth for various internal clients.
  • Execute product holds and releases actions in a timely manner to assure business continuity and avoid backorders
  • Assist in creating and executing relevant RA metrics to support strategic planning.
  • Author SOP/Work Instructions related to scope of work.
  • Uses existing systems and procedures and recommends solutions and/or improvements.
  • Provide professional representation of RA in cross-functional projects and multifunction boards.
  • Provides support to the evaluation of proposed changes to products and controlled documents, and the implementation of global regulatory action based on changes.
  • Experience working on systems & process change implementation projects.
  • Ability to make the complex or ambiguous understood to the business in communications, training and status updates to the business.
  • Hold self-accountable to deliver on tasks, meet business deadlines, deliver on project tasks and meet project milestones.
  • Organizes and maintains regulatory approvals, files and documentation.
  • Responsible for all document formatting, publishing, verification, submission of technical dossier to competent authority and notified bodies.
  • Provides document formatting support to ensure consistency with company guidelines, Good Documentation Practices, and health authority/notified body submission standards.
  • Ensures that existing approvals and documentation are maintained.
  • Communicates with in-country RA personnel to facilitate global clearances/approvals.
  • Performs responsibilities required by the Quality System and other duties as assigned or requested.
  • Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).

 

Requirements

 

  • Bachelor's degree or equivalent work experience required.
  • A minimum of one year in a Regulatory Affairs role preferred.
  • RAC certification or Advance Degree (Master in Regulatory Affairs) preferred.
  • Knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD), and applicable guidance documents preferred.
  • Experience with international regulations preferred.
  • Understanding of the FDA device listing and establishment registration process preferred.
  • Experience with rapidly building product knowledge and understanding of highly technical and scientific regulatory activities.
  • Experience working with Adobe Pro, MS Word and other document editing applications.
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.).
  • Must possess excellent oral and written communication
Company Description
Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.

iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential.

Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!

Contact us today to learn more:
*** Grand Rapids, Michigan: 616.254.8586
*** Tampa, Florida: 813.463.8850
*** www.impactbusinessgroup.com
*** Chat with us live: https://lc.chat/now/8608604/

iMPact Business Group

Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management. iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential. Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference! Contact us today to learn more: *** Grand Rapids, Michigan: 616.254.8586 *** Tampa, Florida: 813.463.8850 *** www.impactbusinessgroup.com *** Chat with us live: https://lc.chat/now/8608604/

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Fremont, CA
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