Job Title: Regulatory Affairs Associate

Location: Abbott Park, IL 60064

Duration: 06 Months (Contract to Hire)

Time: 7 AM – 4 PM

Note:

• 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.

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