SAP Regulatory Affairs Quality Assurance (RAQA) Consultant

RAQA, Regulatory Affairs Quality Assurance, QA, Quality Assurance, SAP
Contract W2, Contract Independent, Contract Corp-To-Corp, 12 Months
Depends on Experience
Work from home not available Travel not required

Job Description

Hi,

 

We have an urgent opening with " SAP Regulatory Affairs Quality Assurance (RAQA) " and I have sent you job description, please go through it and let me know your comfort with it and also send me your updated resume ASAP

 

Title –  SAP Regulatory Affairs Quality Assurance (RAQA)
Location – Portage MI
Duration – Long Term Contract

 

Job Description:

 

  • Possess and apply advanced knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to bring products to market and maintain compliance.
  • Review progress with management; assist Management in training RA Specialists, Senior, or Staff Specialists as required.
  • Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
  • Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
  • Evaluate proposed products for regulatory classification and jurisdiction.
  • Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  • Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
  • Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiencies.
  • Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
  • Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.
  • Demonstrate developing technical leadership skills interdepartmentally.
  • Evaluate medical device regulations and develop strategies for bringing products to market.
  • Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.
  • Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support.
  • Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
  • A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
  • A minimum of 5 years of experience in an FDA regulated industry required.
  • A minimum of 3 years of Regulatory Affairs experience required.
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
  • Experience authoring regulatory submissions for product approval and interacting with regulatory agencies required.

 

Thanks and Regards,

Akhil Verma

Sr. Technical Recruiter

Phone – 973 658 5959 Ext: 120

Cell – (973) 750 4685

Email akhil@epeopletech.com

 

ePeople Technologies Inc.

255 Baldwin Road, Suite  205

Parsippany, NJ 07054

Fax - 973 299 7602

http://www.epeopletech.com

 

Dice Id : 10230118
Position Id : 6143410
Originally Posted : 4 months ago
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