Regulatory Affairs Associate

HI ,

This is Gayatri, senior recruiter at Experis IT Manpower Group. Our client, Medical device manufacturing is seeking a Regulatory affairs associate to join their team. Reg Affairs, IVD or Medical Device, Project Management, and previous Abbott would be ideal

Job Title: Regulatory Affairs Associate

Pay Range: $33/hr

Location: 100 Abbott Park Road , Lake Bluff , IL 60064

Duration: 12-month contract with high possibility of extension

Accountability / Scope

As 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 approach to solutions. Individual shall be good with excel and numbers, so that they can help analyze submission numbers & various metrics.

Responsibilities

Major Responsibilities

Support 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

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

Skills/Experience Requirements

Prior experience (2-3yrs) and Bachelor’s degree in nutrition/science related field. Good understanding and working experience in different regulatory environment 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. Adaptable in cultural and political diversity. Capacity to learn and challenge status quo. Team player Self-motivated.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.