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
- 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,
Sr. Technical Recruiter
Phone – 973 658 5959 Ext: 120
Cell – (973) 750 4685
Email – firstname.lastname@example.org
ePeople Technologies Inc.
255 Baldwin Road, Suite 205
Parsippany, NJ 07054
Fax - 973 299 7602