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Project Associate, Regulatory Affairs QA - Individual Contributor

Date Posted: 9/14/2021

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Job Description

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 back orders
* Assist in creating and executing relevant Regulatory Affairs 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).

What you need
* 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.
* Complying with constantly changing regulatory procedures; reprioritizing work effectively.
* Identifying and correcting errors and inconsistencies (e.g. grammatical, contextual, etc.).
* 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.
* Results-oriented with focus on continuous improvement in quality and regulatory compliance.
* Competent with Microsoft Office (Outlook, Excel, Word, etc.).
* Must possess excellent oral and written communication skills.
* Ability to understand and explain detailed regulatory compliance programs and/or issues.
* Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
* Ability to analyze and resolve non-routine regulatory issues using independent judgment.
* Ability to communicate and network with regulatory personnel to obtain relevant information.
* Excellent analytical and writing skills.

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orienta
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Job Snapshot

  • Employee Type:Full-Time
  • Location:Fremont, CA
  • Job Type:Manufacturing
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:9/14/2021
  • Contact: Laura Fulayter (480) 966-0090
  • Pay Range: $45.00 - $49.00 Hourly
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Job Reference: JO-2109-132856