Regulatory Affairs Associate - Medical

Role: Specialist Regulatory Affairs

Location: Abbott Park, Illinois - 60064-3500

Duration: 8 Months on W2

Shift Timings: 8 AM to 5 PM

Division: NUTRITION

Job 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

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.