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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Rashi at
Title: Specialist Regulatory Affairs
Duration: 7 Months
Location: Abbott Park, IL/ Columbu, OH
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 and other stakeholder to define plan and 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 and various metrics.
RESPONSIBILITIES
Major Responsibilities:
Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF and 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, RandD, Technical center and 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 and scientific aspects of nutritional products.
Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Influence stakeholders on technical solutions.
3-5 years of regulatory exp, nutrition, healthcare, pharma exp or background, FMCG preferred, submission exp, system exp, Regulatory policies, operations exp, industry exp.
Flexible for any regulatory exp but preferred is operations regulatory, building doc, building product docs.
Day-to-day duties
Will work with a team, preparing docs, initially, they will be trained, and pull documents and reports from the system, documentation, it is an execution role, mostly depending on documentation, system experience, and regulations.
Adaptable in cultural and political diversity.
Capacity to learn and challenge status quo.
Team player
Self-motivated.
Education
Lowest level BS with some years of experience
Highest level- MS or PhD with 2 years experience
Interview: 1 round, virtual.
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.