18 Regulatory Affairs Associate - Medical Devices Jobs in North Chicago, IL
intellectt is Hiring a Regulatory Affairs Associate - Medical Devices Near North Chicago, IL
Duration: 8 Months contract only Shift Timings: 7 am to 4 pmAccountability / ScopeAs the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any deficiencies and develop an approach to solutions. Individuals shall be good with excel and numbers, so that they can help analyze submission numbers & various metrics.
Major ResponsibilitiesSupport Regulatory submissions for Food, FSMP, Enteral Nutrition, IF & FUF, Drug for EURI/MENAP/ global. Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changes. Partnership with affiliates to support regulatory agency interactions to expedite approval of pending registration. Participates/ Awareness on project plans, regulatory submission strategy, any risks management. Advises project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Partner with other regulatory functions for smooth project transition and launch. Support review of change controls to determine the level of change and consequent submission requirements. Support pulling reports, metrics related to submissions and approvals. Offers country specific regulatory support System VEEVA experience is helpful. Stakeholders: Direct interaction with RA functions including Regulatory Operations, Submissions Execution, Regulatory Project Management, Strategic Area and other stakeholders such as Project managers, Manufacturing Plants, affiliates, R&D, Technical center & Product Developers. Requirements include:
- Prior experience (2-3yrs) and Bachelor's degree in nutrition/science related field.
- Good understanding and working experience in different regulatory environments in multiple countries.
- Experience in registration filing process of new nutrition products preferred.
- Knowledge and understanding of formulation & scientific aspects of nutritional products.
- Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
- Influence stakeholders on technical solutions.
Job Summary
Contractor
Business Services
$74k-97k (estimate)
07/03/2024
08/01/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
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