Specialist Regulatory Affairs, EURI/ MENAP

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists

Rashi at 630 847 1027

Divya at 224 369 2969

Title: Specialist Regulatory Affairs, EURI/ MENAP

Location: Abbott Park, IL

Duration: 8 Months

Description

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.

Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports.

Review and approval of manufacturing changes for Class III implantable medical devices.

May require an advanced degree and 5-8 years of direct experience in the field.

Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.

Relies on extensive experience and judgment to plan and accomplish goals.

Performs a variety of tasks.

May lead and direct the work of others.

A wide degree of creativity and latitude is expected.

Typically reports to a manager or head of a unit/department.

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.

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

 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.

Skills/Experience Requirements

Requirements include:

 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.

About Us

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.